Strong Heart Study Newsletters
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Investigating Cardiovascular Disease in American Indians
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SHS Newsletter, December 2001, Volume 13,
Number 2
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SHS Coordinating Center Uses Secure Methods to
Protect Participants’ Information
Since
the beginning of the Strong Heart Study, the Coordinating Center (CC), based in
Oklahoma City, has been here to serve the study. Before the beginning of each round of
examinations, the CC helps investigators finalize the study protocol, compiles
a manual of operations, develops data collection tools, establishes computer
databases, designs data management and quality control procedures, creates
programs for data entry,
develops secure mechanisms to
transmit data from field clinics to the CC, and organizes training sessions to
ensure that all the SHS staff understand the study protocols and are familiar
with examination and data-handling procedures.
When examinations start and data collection begins, the CC vigilantly
monitors the progress and inspects the data’s quality. When the data have been collected, the CC
performs most of the statistical analyses to assist investigators to report SHS
findings.
In the current phase of
the study (Phase IV), the programmers in the CC have used Microsoft Access
database software to create custom applications for data entry. While writing the data entry programs, we
also inserted many special functions -- such as logic checks to minimize
unnecessary data errors, and coding for "skip patterns" to correspond
with those that appear in the data collection forms – to speed up the data
entry process.
A
major improvement in the data processing for this round of examinations is that
we are taking greater advantage of the widespread availability of Internet
access and high-speed connections. We
use Terminal Services technology, which involves the data entry personnel at
the field clinic sites connecting their computers to the CC's data entry server
computer through the Internet, for each data entry session. This sets up "real-time"
transmission of data from the field centers to the CC as it is being entered by
field staff. In fact, the Access
application runs exclusively on the CC's computer, while the field center
computers only need to be running the communications software. This allows the CC's programming staff to be
very efficient in maintaining software installations and addressing program
revision needs.
As
the data are keyed in, they are saved in the CC's server computer
immediately. The highly reliable nature
of the Internet communications software employed ensures data transmission
integrity. It is very rare for any data
to be lost during transmission, because if data entry is interrupted by a power
surge or drop (we prescribe the use of battery back up systems to help prevent
this) or a sudden loss of internet connection, data entry staff can simply
reestablish the connection to the data entry server, which will normally allow
the data entry process to resume at the point where it was interrupted. And since the Terminal Services connections
are strictly password-protected and apply very strong (128-bit) encryption
technology to all communications between the field center's computer and the
CC's data entry server, it is virtually impossible for confidential data to be
successfully intercepted during the data entry process.
As
a first step in working with incoming data, the CC's data manager transfers
newly-entered data out of the data entry server on a weekly basis. The data manager performs regular quality
checks, and, after stripping all personal identifiers, distributes these
"raw" data to the CC's programmers or data analysts for second-level
data clean-up purposes only. Later, the
cleaned-up data along with the derived variables will be distributed to the
interested investigators upon their request.
The
CC is also diligent in backing up the data.
Our data back-up procedures include several layers of safeguards to
protect against data loss. We have a
daily back-up, weekly back-up, and monthly back-up, so that if an accident such
as a hard drive failure ever occurs, the damage will be minimal. Our back-up data are stored in cartridge
disks, CD-ROM, and archival tapes. All
the back-up media are stored in locked offices, and regularly-updated copies
are housed in an industrial-rated fire-resistant safe. Those media are only accessible by the CC's
principal investigator, system administrator, and data manager. All the CC's staff, including statisticians,
have signed a pledge to maintain the confidentiality of the data under the CC's
guard.
Funding Search Continues
As
the Strong Heart Study (SHS) investigators and staff talked to participants and
tribal leaders, everybody agreed that it is essential to translate the
information from the SHS into intervention programs that can help to decrease
or prevent the increasing occurrence of heart disease. The SHS investigators believe that their
findings are ready for translation into a clinical intervention. The SHS found that most of the heart disease
is in people with diabetes, that cholesterol levels are strong predictors of
heart disease, and that elevated blood pressure is a risk factor for heart
disease (coupled with its effect on increasing protein excretion from the
kidney). Excellent medications are now
available in the US for lowering LDL cholesterol and blood pressure. While these drugs have not been tested in
studies in Indian communities, they have been tested in many other populations
and approved by the FDA. The SHS
investigators believe that if these current treatment strategies to lower blood
pressure and cholesterol are applied to diabetic American Indian patients, they
will result in lower rates of heart disease.
In order to implement this strategy into medical practice, it is
necessary to test it with a randomized trial.
This means that a study must be performed where the participants will be
divided into two groups, one of which will have current treatment for
cholesterol and blood pressure, and the other group will receive more
aggressive treatments so that their blood pressure and cholesterol levels will
be lowered even further. The SHS has
shown that the ultrasound pictures of the heart and of the blood vessels in the
neck both show changes in individuals with diabetes that are reflective of cardiovascular
disease. These measures can be used in
the study to determine whether the aggressive blood pressure and cholesterol
treatments are effective. The SHS
investigators met and planned a study, which will be conducted in the three
existing SHS communities and also in Chinle, Arizona in order to involve the
Navaho people who also appear to be having greatly increased rates of diabetes
and heart disease.
Attempts to obtain
funding for this program are ongoing. We
initially applied, along with many other people throughout the country, to be
part of a very large consortium to test strategies for lowering heart disease
in individuals with diabetes. Our center
was not accepted to be part of that program.
In retrospect, this is probably fortunate, since that program will be
extremely complex and have a very long-term follow-up with many interventions
that the participants will need to undergo.
SHS investigators have planned a simpler, shorter term (3-years) study
involving only blood pressure and cholesterol lowering. The National Heart, Lung and Blood Institute
agreed to accept an application for independent funding of this project. It was
submitted last year. Current procedures
for obtaining research funding involve a very rigorous peer review process. The application underwent that process, and,
while it received an encouraging score, enough questions were raised that it
could not be funded without resolving some of the issues related by the review
committee. The investigators came
together and rewrote the proposal (which now totals about 400 pages including
appendixes), and this has been resubmitted to the National Heart, Lung and
Blood Institute. It will undergo review
by the Fall Review Committee. We are all
hoping for a favorable review this time, because SHS would like very much to
start as soon as possible to test and prove that the intervention suggested by
our data will be effective in reducing heart disease in people with
diabetes. If we can prove this, then the
interventions will be adopted by care providers throughout Indian country.
Stepping Out ..........and Counting
By
now, many of you may have been told about the pedometer that is being used
during the Strong Heart Study phase IV campaign. You may have wondered what it is and why you
will be asked to wear one. In order to
make this process a little easier, we would like to provide you with some
important information that will help you understand what the pedometer is, what
it does, and why you will be asked to wear it.
® What
is a pedometer?
A pedometer or movement meter is a small
battery operated device about the size of a matchbook. It is very light weight and can be clipped to
your pants or skirt.
® What
does the pedometer do?
The
pedometer captures movement, mostly walking, that you do throughout the day.
® Why
are we asking you to wear a pedometer?
The answer is very
simple. By wearing the pedometer or
movement meter, you will help us to help you. We would like to assess the
movement that you do during the day for a seven-day period. The numbers produced from your pedometer will
help the Strong Heart Study staff determine what a typical week of movement
looks like for you. This information
will help us to provide you with valuable feedback.
In
order to capture a typical week of movement from you, we ask that you do not
change your physical activity levels during the week that you are asked to wear
the pedometer. Keep doing what you would
normally do during the week. Remember, everyone is different in regard to
activity and movement level; the SHS staff will be pleased to receive your
seven day record regardless of the level it shows.
We
look forward to making this phase of the project successful and hope this
information helps you to better understand the pedometer and its
usefulness. If you have any further
questions or concerns about the movement meter, please feel free to contact a
SHS staff member who will be able to answer your questions.
SHS Data
Adds to Indian Health Knowledge
The Strong Heart Study staff
continue to examine community members who are part of large families that will
shed light on genetic as well as environmental contributors to cardiovascular
disease in American Indians. Almost 1200
examinations had been completed as reported in the October meeting of the
Strong Heart Study investigators. The
Dakota Center continued to set the pace with 412 examinations completed. It was followed by Arizona with 388 and
Oklahoma with 358. All three centers were
ahead of the pace that was planned for this examination phase which is a
tribute to the enthusiastic community support for the study and to the
continuing excellence of the SHS staff in recruiting and implementing the exam. We appreciate everyone’s effort in making
this study a success to date; keep up the good work!
Earlier
data from the Strong Heart Study are getting good visibility in areas where it
counts. SHS investigators attended the
Association of American Indian Physicians in August, where they presented two
papers and three posters related to Strong Heart Study data. Several of the presentations won awards for
excellence. American Indian physicians
and researchers attending the conference were pleased to have SHS results and
noted that they hoped to see more in the future.
In
addition, the Strong Heart Study data book has been printed and is being made
available to study community leaders, health care workers, and study
participants; other American Indian communities; political leaders; and
biomedical researchers to keep them informed on the health status of American
Indians and to provide guidance in decision making about allocation of
resources for health care needs. We hope
this data book will be seen as a sign of appreciation for the participants in
the Strong Heart Study and used by the communities and medical community to
improve the health of current and future generations.
Genetics
...Where’s the Beef?
fourth in a
series of articles by Lyle Best, MD
We have heard so much about the
promise of genetics in the past number of years that some people have wondered
whether this is just another example of media “hype” and no practical results.
If you were expecting genetics to change the genes you inherited so that you
can eat all the cheeseburgers you want, or produce an un-limited supply of
genetically matched pigs’ hearts that can be transplanted whenever your heart
fails.... then you have been disappointed. Still, genetic discoveries have led
to some little-known medical advances that are used everyday.
Many
of you probably take cholesterol lowering medication with a name that ends with
“...statin.” There are only a few medicines that we know can prevent heart
attacks and death if used properly, and this group of cholesterol medications
has proven to be one of the best. How these
medications were discovered tells us much about the way genetics can
improve our health.
In
the middle 1950’s studies much like SHS (except in white communities) showed
that high cholesterol levels made heart disease much more likely. Genetic
scientists knew of families that had very high levels of cholesterol because of
mutations in genes they passed from one generation to the next. In 1973 two
Nobel Prize winning researchers discovered that a gene in these families failed
to produce the proper form of a cholesterol receptor on liver cells. In the
late 1980’s the “statin” group of medicines was developed from some kinds of
fungus; and by the early 1990’s the benefit of these medicines was being proven
in tests involving thousands of participants around the world.
Many
of you use insulin to help control diabetes, or you may have used a
clot-dissolving medicine to stop a heart attack that was developing. Although
insulin was discovered in the 1920’s and was extracted from the byproducts of
pork and beef slaughter for many years; in the 1970’s genetic methods were used
to produce insulin from yeast that was identical to human insulin and avoided
possible contamination from viruses
that animals might carry. The drugs used to dissolve clots and stop heart
attacks and strokes are also made using genetic methods, as are 50-60 vaccines and other
important medicines that we use every day.
So while genetics hasn’t perhaps been as important as some people
predicted a few years ago, it has still provided many benefits and the best is
probably still to come.
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SHS Newsletter, April 2002, Volume 14,
Number 1
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Taking Medicines: Too Many? Not Enough?
Elders usually have more
illness than younger people. They often
take several kinds of medicine. Using
many medicines (polypharmacy) can cause drug reactions. Sometimes drug reactions can be serious
enough to cause death.
The number of American
Indian elders is growing. Many elders
need to take medicines for diabetes and high blood pressure. They may have
other conditions and take medicines (including traditional herbal remedies) for
those as well. Researchers have studied
what happens when older people take many medicines in the general
population. No one has studied American
Indian elders and the effects taking many medicines may have on them. Strong Heart Study data provide information
in this area.
Strong Heart Study
participants have made it possible for scientists to learn more about what
happens when elders take many medicines. Participants brought all their
medicines to the first SHS exams.
Researchers were able to create a record of the medicines taken by participants. By studying these records, SHS scientists
will be able to learn more about how taking many medicines affects older
American Indians. Researchers will share
what they discover in articles they are writing now.
SHS scientists graphed
the information collected and saw some interesting things. More than one third of participants were
taking no medicine. Almost half were
taking from one to three different kinds of medicine. About 17% were taking four or more different
kinds of medicines. Chart 1
Are
SHS participants taking more or fewer medicines than other groups that have
been studied? Again, the researchers
graphed the SHS information with data from
a
study in rural North Carolina and from a study in Seattle. Chart 2
As
the graph shows, SHS participants used fewer medicines than either of the other
two groups. More of the SHS group take
no medicines. Although SHS group had the
highest percentage of people who reported taking one or two medicines, SHS
participants had the lowest percentage of people taking three or more
medicines.
SHS
group's low number of medicines was a surprise since many of the SHS group have
diabetes or high blood pressure. Now
researchers are looking at whether some SHS participants may be under treated
for their medical conditions. Chart 2
Taking
the right amount and kind of medicines for conditions being treated is
important to good health. Always call your doctor or pharmacist if you think
your medicines may be causing problems.
If you want more information about taking several medicines at the same
time, please contact your SHS office.
Strong Heart Study
Stays on Track
The National Heart,
Lung, and Blood Institute of the National Institutes of Health funds the Strong
Heart Study. NHLBI must be certain that
the SHS study follows guidelines for good research. To do this, NHLBI names a committee of
scientists to examine the way the Strong Heart Study operates. The group is called the Observational Study
Monitoring Board. SHS researchers give the OSMB reports at least once a
year. Researchers report on topics such
as how SHS signs up new participants, the number of times and ways SHS shares
results of the study, changes in study plan, and unfavorable events. The OSMB studies the reports and recommends
actions to the NHLBI Director. The most
important question OSMB answers is whether or not to continue the study. The committee also gives advice on new sub-studies,
study safety, and how stored samples should be used.
OSMB
members come from across the country.
The chairman of the Board is Dr. Greg Burke from Wake Forest University
School of Medicine. The executive
secretary of the board is Dr. Paul Sorlie, from NHLBI. Other board members are
Dr.
Eric Boerwinkle – University of Texas
Dr.
John Eckfeldt - University of Minnesota
Dr.
Dorothy Gohdes - New Mexico
Dr.
Jennie Joe - the University of Arizona
Dr.
Francine Romero - Northwest Portland Area Indian Health Board
Dr.
Patricia Wahl - University of Washington.
Dr.
Gerald Ignace is a past president of the Association of American Indian
Physicians. He was a member of the OSMB
for many years. Dr. Ignace resigned from
OSMB recently because of heavy clinical responsibilities.
SHS
Ahead of the Game on Exams
The Strong Heart Study
is ahead of schedule. Mid-February
reports from the centers show that all centers have completed more examinations
than targeted. Center totals are very close in number to each other:
North
and South Dakota – 556
Arizona
– 544
Oklahoma
- 546
The Strong Heart Study
is a good model. SHS's success is due to strong community and participant
support and the hard work of examination teams. We look forward to a strong
finish as we enter the second year of examinations.
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Heart fact: Each
minute, the heart pumps about 6 quarts of blood 3 times throughout the body |
Adiponectin
and Insulin Resistance
Everything we do, even
breathe and walk, takes energy. We get
energy from food. Our bodies take the food we eat and change it into energy
that we can use now or store as fat to use later. This process is complicated. Scientists are
learning more about the process and the many things that can affect how well
the body performs this necessary task. One thing that scientists know is that
the body must be able to use insulin it produces to process sugar and starches
into energy. Someone whose body can't
use insulin has a condition called insulin resistance. Insulin resistance often leads to diabetes.
Researchers
believe that some substances produced in fat cells (adipose tissue) may help the
body's ability to use insulin (increase insulin sensitivity). One of these substances is called
adiponectin. Adiponectin is a protein
that circulates in the blood. Adiponectin levels in overweight people are lower
than in people with normal weight. Scientists have questions about how
adiponectin levels may affect health:
Could
having higher levels of adiponectin protect against becoming overweight?
Could
lower levels of adiponectin signal higher heart disease risk?
SHS
researchers are planning to look at these questions. They will measure adiponectin levels in stored
blood samples taken during Phase II.
Adiponectin levels will be compared with the number of heart problems
which developed after the samples were taken.
The study may show that having less adiponectin leads to insulin
resistance, diabetes, or heart disease.
If this is the case, doctors may be able to use adiponectin levels to
know which patients are at risk. This information could even lead to drugs
which raise the level of adiponectin and prevent diabetes and heart disease.
Lipid Levels Treatment
Guideline Now Available
Research is best when
information leads to action. Strong Heart Study researchers recently saw their
work become action with the creation of treatment guidelines for a major risk
factor of heart disease. That risk is abnormal lipid levels in the blood.
Lipid
levels that are risk factors for heart disease are:
high "bad
cholesterol" (LDL)
low "good" cholesterol (HDL)
high fat (triglyceride)
levels
SHS
research showed two reasons for action:
high
heart disease rate among Native Americans
high
cholesterol seems to create a greater risk for heart disease among Native Americans than among others
In December 2000 more than
70 Indian Health professionals met in Phoenix.
The goal of their meeting was to decide the best way to treat abnormal
lipid levels. Strong Heart Study researchers Jim Galloway and Barbara Howard
led the group to make a framework for treatment guidelines. In January 2002 SHS researchers could see
their work in action. The full set of
treatment guidelines was released.
Doctors and clinical health professionals now have good information to
help them prevent heart disease.
These
guidelines are on the web at http://www.ihs.gov/MedicalPrograms/Cardiology/LipidGuidelines.pdf.
Strong Heart Study On the Web
People say that you can
find anything on the Web. Whether or not
that is completely true, the Strong Heart Study website has been revised and
you can now find the most current information about what’s going on in the
study by visiting this site.
The
address of the revised site is http://caihr.ouhsc.edu/strongheart/. Anyone can browse the menu bar on the left of
the page and learn about the study’s
principal
investigators
organizational
structure
participating
communities
phases
I - IV exams
publications
Other
features of the website include a link to view the SHS Data Book, and the SHS
Operations Manual. The text of
newsletters are also posted online.
The
website is a work in progress for the SHS Coordinating Center in Oklahoma City.
Webmaster Yiming Wang says that menu items marked with a star (*) are still
under construction. The SHS Operations
Manual, for example, is presented by sections in PDF files. Eventually viewers
will be able to choose how they want to view the Operations Manual, either HTML
or PDF format.
Viewers
can also easily travel from the SHS website to related sites with one
click. Links are provided to many
organizations including the Centers for Disease Control, the Indian Health
Service, the Department of Health and Human Services and the National
Institutes of Health. In addition, a
section called Special SHS links, takes the viewer to a page with information
directly pertaining to the Strong Heart Study.
(A link to the lipids treatment guide described on page 3 of this
newsletter is on the Special SHS links page.)
One
section of the website requires a password.
By logging in, SHS researchers can keep up with the latest decisions of
the SHS Steering Committee and Data Sub-Committee.
Take
a look at the SHS website. If you have
suggestions, please e-mail the Webmaster at yiming-wang@ouhsc.edu. Please indicate subject as SHS Website.
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SHS Newsletter, September 2002, Volume 14,
Number 2
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Gila River Indian Community
Elders and SHS Steering Committee Meet
More
than 100 gathered on July 10 at the Elders' Concerns Meeting of the Gila River
Indian Community. Mary Thomas chaired
the meeting of community members. The Strong Heart Study Steering Committee and
the SHS Arizona staff attended.
Barbara
Howard presented copies of the Strong Heart Data Book to all of the
elders. SHS researchers have given
communities various findings of the Strong Heart Study in the past. The data book gathers together and explains
many SHS findings in one easy-to-use document.
Dr.
Howard also told the group about a new project, SANDS (Stop Atherosclerosis in
Native Diabetics Study). SHS researchers
have been working on the planning and funding of the project for three years. The study will look for ways to either stop
or reverse developing heart disease. Dr.
Howard told the group how the study will proceed and asked the elders for their
ideas. Many elders asked questions and
gave advice. As suggested, Arizona
Strong Heart staff will visit all districts giving information and asking for
advice.
The
group visited further at lunch. Many of
the elders present were participants in the Strong Heart Study. Their willing help contributed toward
understanding heart disease in the community.
SHS scientists and staff are grateful for their support. The 24 SHS representatives (from Washing-ton,
D.C., New York, North and South Dakota, Oklahoma, Texas and Arizona) enjoyed
the meeting and the chance to hear elders' concerns.
Allergies Affect Health
of American Indians
Thirty
years ago a University of Oklahoma physician and researcher, Dr. Everett
Rhoades, observed that very few American Indians had asthma. That is not true today.
Of the 3197 participants of the third SHS exam, 10% of the women and 5% of the men said they have asthma. Twice that many reported having hay fever or sinusitis (infection of the sinus passages). Dr. Paul Enright of the University of Arizona supervised breathing tests for 600 of the exam group, and SHS staff gave them allergy skin tests.
Asthma,
hay fever and sinusitis are all related to allergies. People with air-borne allergies can
experience hay fever when they inhale particles of the allergen (what they are
allergic to). They may sneeze. Their nose may be runny or congested or
itchy. Sometimes their eyes may get
itchy and red for hours. (Doctors call
this disease allergic rhinitis rather than hay fever, because the disease is
not caused by hay and there is no fever!)
Hay fever can also cause a sinus infection if the congestion in the nose
prevents the sinuses from draining properly into the inner nose.
When
people with asthma are exposed to allergens, they may have a more serious
reaction than hay fever. Allergens can
trigger an asthmatic "attack" or swelling of the lining of the
airway. This allergic reaction makes it
difficult for the person to breathe.
Clearly, anyone with allergies should avoid allergens to prevent reactions. Avoiding allergens is easy if the allergen is obvious. When symptoms start a few minutes after contact with a cat, for instance, the person is probably allergic to cats. Many allergens are not obvious and can be all around us, like allergens from trees and weeds. The only way to discover allergies to those widespread allergens is to have a skin test. A drop of allergen is put on the arm with a plastic toothpick. If the skin becomes itchy, raised or red where the allergen was placed, the person is allergic to that substance.
Dr.
Fawn Yeh, a researcher at the University of Oklahoma, says that 10% of SHS
participants with hay fever or asthma were allergic to one or more of the
following: various grasses, weeds, trees, molds, house dust mites, cockroaches,
cats, dogs, horses or cattle. Completely
avoiding some of these would be very hard. (How could you avoid something you
can't even see like a dust mite?)
While
totally avoiding some allergens may not be possible, there are many things that
can be done to limit exposure to:
·
Dust mites. Contain dust mites. Enclose pillows, mattresses and upholstered
furniture (where dust mites live) in allergen-proof covers.
·
Mold. Eliminate moist conditions. Repair water leaks in home and use
refrigerated air conditioning rather than cooling by swamp cooler to keep
indoor humidity below 40%.
·
Cockroaches. Eliminate their food sources. Store all food in plastic or metal containers
and remove crumbs of food and grease from kitchen surfaces.
Two helpful books on allergies and asthma are My House Is Killing Me by Jeffrey May and Doctor Tom Plaut's Asthma Guide by Tom Plaut. Information is also available on the Web at www.webmd.com.
Sleep Study Moves
Forward
Strong
Heart Study participants in the Sleep Heart Health Study (SHHS) continue their
strong support of the sleep study. The
SHS centers of the sleep study finished the second round of data collection
before any other SHHS center. Not only
that, but nearly 100% of the first round participants returned for the second
round of exams. "This is a
remarkable achievement given the inconvenience of having an overnight sleep
study," said SHS scientist Helaine Resnick. "Finishing first two times in a row
shows how dedicated Strong Heart participants are to the goals of Strong Heart
as a whole," Dr. Resnick added.
Researchers
have already learned a great deal from the round one data. One of the reports showed that sleep apnea
(brief pauses in breathing during sleep) and high blood pressure are related. If sleep apnea causes high blood pressure,
having sleep apnea may increase the risk of heart disease by increasing blood
pressure. (High blood pressure is a
known heart disease risk factor.)
Scientists are studying this question further.
Dr.
Resnick examined the relationship between sleep apnea and diabetes and found
that people with diabetes had more sleep apnea than those who do not have
diabetes. What scientists do not know is
whether diabetes can cause sleep apnea, or whether sleep apnea can cause
diabetes. Both are possible. Resnick explained that one of the reasons
diabetic people have so much sleep apnea is the weight factor. Many diabetics tend to be overweight and
being overweight is also a risk factor for sleep apnea. "When the effects of being overweight
are taken into account, the relationship between diabetes and sleep apnea is
greatly reduced. This supports the idea
that obesity, rather than diabetes, is the key to most kinds of sleep
apnea. However, we must still untangle
the cause-and-effect relationship here, and this is very difficult," she
added.
The
Sleep Heart Health Study has published 14 scientific papers from the research
done so far. Six more papers have been
accepted for publication and researchers are preparing an additional 40.
"Now
that we have completed the second phase of data collection, we are ready to ask
questions about how sleeping habits change over time, and whether these changes
influence the risk of heart disease," said Resnick. "We are considering writing more grant
proposals to examine diabetes and sleep in greater detail in the Sleep Study,
but there are other questions we could ask as well. We are very excited about the possibilities
for the future," she added.
The
National Heart, Lung, and Blood Institute funds both the Strong Heart Study and
the Sleep Heart Health Study.
Participants for the sleep study come from several large heart
studies. American Indians from the
Strong Heart Study are 10% of the total SHHS study group.
Centers Report Family
Study Exams Ahead of Schedule
All
centers have great news. Recruitment for
the Strong Heart Family Study is high.
Centers report large numbers of completed examinations:
• Arizona 764
• Oklahoma 752
• Dakotas 762
All centers expect to complete their exams early.
Staffs
will soon begin second examinations of pilot study participants. In 1997, over 900 people from 32 families of
Strong Heart Study participants took part in the pilot Family Study. The remarkable success of this pilot study
convinced the National Heart, Lung, and Blood Institute to fund today's large
Strong Heart Family Study. The Strong
Heart investigators want all of the pilot Family Study members to know how
important it is for them to return later this Fall or in 2003 for a second
exam. The repeat exam will give
participants another look at their risk factors. They will be able to see if their risk
factors have improved since their first exam in 1997.
Some
of the procedures and forms used in today's family study are different from
those used in the 1997 pilot study.
Researchers need data from the second exam to have complete
information. SHS scientists cordially invite
and encourage all pilot study participants (those seen in 1997) to return for
their second exam. SHS staff will soon
begin contacting the pilot study participants to schedule the second exams.
Why
heart disease risks are higher among some American Indian families is an
important question. Strong community
support of the family study makes it possible to look for answers. Researchers are excited because they will
soon be able to share information from this important study.
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SHS Newsletter, May 2003, Volume 15, Number
1
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Stop Atherosclerosis
in Native Diabetics Study Begins
The
Stop Atherosclerosis in Native Diabetics Study (SANDS) began recruiting
participants in April 2003. This is the
first study ever to explore ways to prevent or reverse the progression of
cardiovascular disease in American Indians with diabetes. The National Heart, Lung, and Blood Institute
announced the funding of SANDS in September 2002. SANDS is a clinical trial that will be
conducted in four geographic areas.
Three areas are sites of the Strong Heart Study; Phoenix AZ, Lawton OK, and Rapid City
SD. The fourth site is Chinle AZ so that
members of the Navaho community will be able to participate in this
program. We have reported previously in
this newsletter that the Strong Heart Study found a rapidly increasing rate of
heart disease in American Indian communities.
Most of this appeared to be in individuals with diabetes. Their results also showed that both LDL
cholesterol (the bad cholesterol, a type of fat in the blood) and blood
pressure were strong risk factors; that
is, individuals with higher levels of LDL or blood pressure had the greatest
chance of developing heart disease. The
SANDS clinical trial is testing a prevention strategy that will treat LDL
cholesterol and blood pressure to targets that are lower than currently
accepted treatment guidelines. There is
currently debate throughout the country about whether treatment targets in
individuals with diabetes, because they are at such high risk for heart
disease, should be lower for both LDL cholesterol and blood pressure. The SANDS study seeks to answer this
question.
The
study staff will recruit 124 diabetic men and women (at least 40 years of age)
in each of the four centers. These
individuals, after careful screening for other health problems, will be
randomly assigned to either an intensive care group where their blood pressure
will be lowered to 115/75 mmHg and their LDL to 75 mg/dl, or to a control group
whose blood pressure and cholesterol will be treated to currently accepted
targets, 130/80 mmHg and 100 mg/dl. Only
FDA approved medications will be used in the program, and participants will be
carefully monitored for side effects and the effectiveness of cholesterol and
blood pressure lowering agents. Study
participants will be seen often, at least four times a year, and study staff
will also make sure that they receive their regular diabetes care at their
local IHS or tribal clinic. At the
beginning and after three years, ultrasound will be used to measure thickness
of the arteries in the neck and to measure heart function. These will be the endpoints of the study, and
the rates of change will be compared in the aggressive and the usual care
groups.
SANDS staff at all four
centers will be closely aligned with their communities and will work closely
with the community and tribal leaders throughout the five years of this
program. Principal Investigators at the
four field sites are Dr. Charlton Wilson, currently an internist at the Phoenix
Indian Medical Center, Dr. Bryce Poolaw, Clinical Director of the Lawton
Hospital and a member of the Kiowa community, Dr. James Galloway, IHS
cardiologist, and Dr. Jeffrey Henderson, President of the Black Hills Center
for American Indian Health and a member of the Lakota community. The SANDS and Strong Heart Staff are working hard to make this study a
success and hope that its results will lead to better care and less heart
disease for American Indians with diabetes.
Strong Heart Study and Communities: Tradition of Enrichment
Since
the Strong Heart Study began in 1988, the SHS investigators have made every
effort to help the Indian communities that participate in the study. One of the biggest benefits has been the
large number of tribal members who have worked on the study, thereby gaining
experience in the health-related research.
The human resources that have developed as a result of the SHS are very
empowering for the participating tribes, because their capacity for conducting
their own research has greatly increased.
In addition, all the SHS employees have become more health conscious and
have served effectively as health educators and role models for their
communities, advising the participants and the communities in how they can
obtain the best health possible. On the
other hand, the SHS has benefited greatly in many ways, too. Staff members from the local communities
bring the perspectives of the communities directly to the study. They represent the study in the most friendly
and familiar way possible for the comfort and confidence of the
participants. Having community members
as an integral part of the study helps ensure the relevance of the study
questionnaires and overall goals to the communities and that all aspects of the
day to day workings of the study are conducted with cultural sensitivity.
Each
center has many examples of employees who have contributed to the health of
their communities in outstanding ways.
Of the 138 people who worked on SHS at the Dakota Center since 1988, 64
are American Indians and 40 were health professional students at the time they
first worked on SHS. Kurt Schweigman,
MPH, a member of the Oglala Sioux Tribe of Pine Ridge, SD, was a college
student when he first worked on SHS in 1990.
His work on SHS stimulated his interest in epidemiology. After graduation from the University of North
Dakota, Kurt obtained an NIH Intramural Research Training Award and spent
almost a year working at the National Heart, Lung, and Blood Institute where he
gained work experience in epidemiology that resulted in a published paper. Kurt then earned a Masters of Public Health
degree from the University of Oklahoma.
During his training in Oklahoma, Kurt received support for his graduate
work through the Minority Graduate Research Supplement program of the National
Heart, Lung, and Blood Institute. Kurt
worked as a graduate research assistant in the SHS Coordinating Center in OK at
the Center for American Indian Health Research.
Recently Kurt has returned to Rapid City, SD, to work on the EARTH
project, a study of chronic diseases among American Indians and Alaska Natives.
Marcia
O'Leary, RN, a life-long, non-Indian resident of the Cheyenne River Sioux
Reservation, was a Presentation College
- Lakota campus nursing student when she first worked on SHS in 1992. Marcia and her husband, Timothy O'Leary, a
member of the Cheyenne River Sioux Tribe, have formed a Buy-Indian corporation,
Missouri Breaks Research, Inc., Timber Lake, SD, which is the grant recipient
for the Dakota Center SHS. Two Dakota
Center SHS staff members, Danial Kougl and Lillian Brown, presented a poster at
the 15th Annual IHS Research Conference, Scottsdale, AZ in May 2003.
Jeff
Henderson, MD, MPH, a member of the Cheyenne River Sioux tribe, received an
NHLBI Minority Supplement to work on the Strong Heart Study in 1998. Dr. Henderson subsequently formed the Black
Hills Center for American Indian Health, which has received several large
grants to conduct research on health problems afflicting Northern Plains
American Indians. SHS data have been
made available to Native American graduate students for research. The principal investigators and
co-investigators have worked closely with the students in developing their
thesis plans and dissertations. Chani
Phillips, a member of the Cheyenne River Sioux Tribe, completed her PhD in
psychology utilizing SHS data with the supervision of Dr. Tom Welty.
The
Oklahoma Coordinating Center/Field Center has been fortunate to have 26
community members join the study as staff members, several of whom have served
SHS throughout most of the study. Linda
Poolaw and Stephanie Gomez have been with the SHS Oklahoma Center for about 10
years or more, and Juanita Cortez retired in 2001 after more than 10 years of
service. All of the staff members have
contributed greatly to the continued success of the project. Oklahoma SHS has actively pursued the goal of
promoting the interest and success of young American Indians in developing
careers in health. As mentioned above,
the NHLBI, the Dakota Center and the Oklahoma Center all have helped Kurt
Schweigman develop his interests and career in epidemiology. Valarie Jernigan, a member of the Choctaw
Tribe in Oklahoma, has just completed her graduate assistantship at the Oklahoma
Center. Valarie is the seventh American Indian student in the Oklahoma Center
to receive support through the NHLBI Minority Graduate Research Supplement
program. Valarie obtained an MPH in
Health Promotion Sciences in the College of Public Health at the University of
Oklahoma Health Sciences Center.
She worked as a graduate research
assistant in the SHS Coordinating Center, learning as much as possible about
the workings of a coordinating center, performing data entry and statistical
analyses, working on papers to present at national scientific meetings and to
publish in scientific journals. Valarie
has worked on SHS data on access to health care, and she presented her findings at the IHS
Research Conference in May 2003.
The Arizona Field
Center has also had many community members join the study as staff members and
as students working for brief periods of time.
All interested community members have been encouraged to contact and
work with the staff in order to pursue their own interests in health and/or
research occupations. Since the start of
SHS, the Arizona Center has had 41 staff members representing different tribal
communities. Many of these people have
gone on with their career development in health-related fields. Some examples include: master's degrees in
nursing, BS in nursing, radiography technician, certified ultrasound
technician, and a degree in business administration. For example, Brian O’Leary, a member of the
Cheyenne River Sioux Tribe, received a minority supplement from NHLBI through
the MedStar Research Institute. He
worked with Dr. Barbara Howard in the utilization of the SHS data to develop
his thesis and dissertation. He is
currently interning at Walter Reed Medical Center and will defend his
dissertation in the fall of 2003. Others
are taking classes towards degrees. The
current staff includes two community
members who presented posters at
the Indian Health Service Research Conference in May 2003. The contribution of these community members
to the Strong Heart project is essential and vital to the success of this
project.
The
SHS is very proud to have made these contributions to the human resources
available to conduct research in Indian communities. We will continue this tradition as we plan
for the fifth phase of the study.
Testing
Possible Heart Disease Genes
As you know, one of the
main goals of SHS-Phase IV is to find out how genes we inherit from our parents
affect our chances of having heart disease, diabetes, and risk factors for these diseases. The main way
that this will be studied, is by "linkage analysis", which attempts
to find the location of genes along the chromosomes, or DNA of a person. This
testing is coming along well, and the results will start to be analyzed soon.
The
other way of testing is called "candidate gene" analysis. This looks
at certain changes in known genes that are thought to have a possible effect on
heart disease. Most of these candidate
gene changes have already been suspected of increasing the risk of heart disease
in other, non-Indian populations. The
researcher then checks to see if these changes are present more often in people
who have the health problem.
In the near future, a
number of candidate genes will be tested from SHS participants' samples.
Research colleagues of Dr. Howard in Washington, DC, and others will be
checking on the effects of the angiotensinogen gene on diabetes, obesity and
kidney injury. Cornell University, which also reads all of the echocardiograms
etc for SHS, will be investigating whether this same gene affects the enlargement of the heart that is
common among SHS participants. Other researchers with Dr. Howard will be
testing whether differences in genes that produce some of the fat-carrying
proteins in our blood, influence our risk for heart disease.
You
may remember a newsletter article about a gene for mannose binding protein (MBP). The analysis
is not yet complete, but there appears to be an increased risk for heart
disease in people who have changes in this gene.
All of this testing is
in a very early stage and whether these findings are confirmed and turn out to
be helpful to doctors taking care of patients, is still unknown. We are excited
though, to begin the process of learning about the effect of genes on our
health.
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SHS Newsletter, December 2003, Volume 15,
Number 2
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Strong Heart Study Staff Completes Phase IV Early
The Strong Heart Study has built a track record that is nothing short of
extraordinary. That track record has
continued with Phase IV of the Strong Heart Study. The Phase IV goal for each center was to examine
1,200 participants from approximately 40 families. As of the end of August, all three centers
completed the project one month ahead of schedule with the number of
examinations completed by each center as follows: Arizona - 1202; Dakotas -
1206 and Oklahoma - 1210. The staff of
each center is to be congratulated not only for meeting the recruitment goals
of the study but also for maintaining high quality data collection throughout
the examination phase. Dr. Richard
Devereux, Cornell Medical School, noted that the ultrasound imaging meets or
exceeds the quality of many of the research studies conducted in urban areas by
major research institutions.
Dr. Barbara Howard, Steering Committee Chair, echoed
remarks from earlier phases of the Strong Heart Study when she noted what a
wonderful experience it has been working with the team over the years to
consistently demonstrate that excellent research can be done in Indian
Country. Dr. Elisa Lee, Principal
Investigator for the Oklahoma Center, suggested that the mutual respect and
level of support of the communities over the years has greatly facilitated the
research effort. Dr. Richard Fabsitz,
NHLBI Project Officer, noted that this was the fourth example in a row of the
Strong Heart Study communities and staff delivering on the stated goals of a
research study. "It is really a
pleasure to be associated with this group of investigators and these
communities." Dr. Jim Galloway, IHS
cardiologist, noted how the Strong Heart Study data had already become a major
contributor to health planning for American Indians. Efforts will now focus on analysis of these
valuable data to generate information that will be useful to improve the health
of individuals, their communities, and future generations of American Indians.
Strong Heart Study Generates New Information on Outcomes Related to
Leg Blood Flow
The generosity and
dedication to wellness of Strong Heart Study participants has resulted in the
collection of a large amount of information on the health of blood vessels in
the heart, neck and legs. Strong Heart
scientists recently asked questions about how painless measures of blood flow
to the legs and feet may be associated with risk of cardiovascular disease
(CVD) and mortality. These questions are important since it is known that
reduced blood flow to the legs is common in diabetes, and both conditions are
related to poor health outcomes.
Blood flow to the legs can
be assessed by comparing blood pressure at the ankle with blood pressure in the
arm. This is called the “ankle-brachial
index” or “ABI.” In healthy people, the
ABI is about 1. In people who have
problems with blood flow to their legs, the ABI can be less than 1 or more than
1. Previous studies have shown that a
low ABI is a warning for future development of CVD. However, there are no reports on the
relationship between a high ABI and future CVD.
This is an important question in the Strong Heart Study, since a high
ABI is common in diabetes.
Strong Heart Study scientists
wanted to see if either a high or low ABI was a warning for CVD mortality in
the SHS population. The results showed
that both high and low ABI were associated with death due to CVD. Participants with low ABI had about 2.5 times
the risk of dying due to CVD during the ten years of follow-up (when compared
to those with normal ABI). Participants
with a high ABI had about twice the risk for CVD mortality compared to those
with a normal ABI.
These results support
earlier studies showing a relationship between low ABI and increased risk of
death due to CVD, but Strong Heart Study data extended these findings to
include the diverse group of American Indians in the study. In addition, data from this investigation
also show a relationship between high ABI and increased risk for CVD-related
mortality. This is important new
information because of high rates of diabetes in the Strong Heart Study
population and the increasing rates of CVD.
A high or low ABI may be an important factor to measure in the doctor’s
office when considering a risk for CVD
among American Indians.
Genes and Drug Effects
The good and bad effects of
medicines depend on many things. Sometimes the food we eat with a medicine will
change the way it works. Sometimes two medicines will work against each other.
Some medicines have to be taken at exactly the right times, or many times a
day; and it is hard to take them correctly.
Besides this, of course, our
bodies are slightly different. Some people are extra sensitive to the effects
of a medicine. Some of us break down medicines, or flush them out through our
kidneys or liver quicker than the next person. Many scientists think that a lot
of these differences come from genes or special qualities that we inherited
from our parents.
Dr. Raymond Woosley and Dr.
Patricia Thompson at the University of Arizona in Tucson are especially
interested in testing some of the genes that have been found to change the way
people break down and get rid of medicines. In other studies, some people with
certain of these genes don’t pass these medicines out of their body as fast as
the average person; and so they start to build up and sometimes cause side
effects. Sometimes the medicines are broken down too fast, and they don’t have
a chance to work like they are supposed to.
These researchers don’t know
if American Indian (AI) people have these same kinds of genes or not. This
testing will tell us more about how AI people react to their medicines; and
someday, maybe this will let doctors do a better job of prescribing a better medicine,
at a dose that fits the patient better.
SANDS Stop
Atherosclerosis in Native Diabetics Study
As you may know, SANDS is a study funded by the National Institute of
Health to try to reduce or prevent heart disease in Native Americans with
diabetes. It is now well underway in the
Phoenix, AZ, Chinle, AZ, Rapid City, SD, and Lawton, OK areas. Currently, over
250 people have been enrolled, but we need about 250 more.
The Strong Heart Study found
that heart disease is rapidly increasing in Indian communities. Heart disease is caused by atherosclerosis
(hardening and clogging of blood vessels).
SANDS will study strategies to see if using medicines for lowering blood
pressure and cholesterol can stop this from happening.
If you are interested in
joining, you will be scheduled for two screening visits to obtain your medical
history and measure your blood pressure and cholesterol. If you are eligible, you will be given
medicines to lower your cholesterol and blood pressure, and you will be
followed for 3 years. An ultrasound
picture (like the one taken of babies for pregnant women) of the vessels in
your neck and heart will be taken at the beginning, middle and end of the 3
years.
After you enroll you will be
followed every 3 months for 3 years. During
that time we will check your blood pressure and cholesterol and adjust the
medicines to meet your goals. We will do
this along with your regular doctor.
SANDS visits will not take the place of your regular doctor visits.
If you join the study, you
will not only be followed closely for your blood pressure and cholesterol, but
you will also have the satisfaction of knowing that the results from SANDS may
help improve your health and the health of Native Americans with diabetes for
generations to come.
If you would like to know
more about SANDS, please call the SANDS clinic in your area.
Phoenix area: 1-888-90SANDS
(1-888-907-2637)
Lawton area: (580) 678-0676
Rapid City area: (605)
716-4812
Chinle area: (928) 674-7589
Better Medicine Through
Genetics
Most of the cells in our bodies
contain 23 pairs of chromosomes. One
chromosome of each pair is a copy of a chromosome we have received from our
father and the other is a copy of one from our mother. All of our genes are located on these 23
pairs of chromosomes. Our genes help
determine what diseases we may develop.
Learning about the genes that lead to heart disease, diabetes, high
blood pressure, and obesity can help us learn how to prevent and treat these
diseases. One of the first steps is to find
the exact location of each gene (which chromosome is it on, and which part of
that chromosome?).
In the Strong Heart Study,
we are collecting information from people in large families. We ask about diseases, we evaluate disease
risk factors, and we collect DNA, which is the material that genes are made
of. We are using powerful computers to
analyze all of this information and to try to pinpoint the locations of genes
that may lead to disease. This is a big
job that is just beginning to give us some results.
We know that the
relationship between diseases and genes is complicated. More than one gene (perhaps many genes) may
work together to influence our disease risk.
The effects of these genes also may depend on things like diet, smoking,
and other life style factors. If we can
locate one or more genes that influence risk of heart disease or diabetes, then
we can isolate the genes and find out how they work. We hope that our work will someday lead to
new ways of preventing and treating diseases.
Lower-Extremity
Amputation Related to Poor Health Outcomes
American
Indians have very high rates of type 2 diabetes. A lower extremity amputation (LEA) is one of
the most disabling complications of diabetes.
LEA results from damage to the nerves and blood vessels in the legs and
feet that comes from high blood sugar levels.
LEAs occur with significantly greater frequency in diabetic American
Indians than in diabetic people of other ethnicities. Strong Heart Study (SHS) investigators wanted
to understand the long-term health consequences of American Indians with
LEA. The overall results of the study
showed that SHS participants with LEAs are at substantially increased risk of
death from all causes and from heart disease compared to SHS participants without
a LEA.
Out of 4,549 American
Indians seen in the first SHS exam (between 1989 and 1991), 134 SHS
participants had a LEA due to diabetes.
These people represented 6% of all SHS participants with diabetes. Eighty people had a toe amputation, 53 had an
amputation below the knee (BKA) and 1 person had an amputation above the knee
(AKA). Participants with a LEA had
higher systolic blood pressure and LDL cholesterol levels than people without a
LEA, and they also had worse kidney function and circulation in their legs
compared to people who did not have a LEA.
Investigators
discovered that a participant’s risk of experiencing a LEA increased with the
time he or she has had diabetes. In
addition, diabetes duration was longer in those who had “more” of the leg
amputated. For example, participants
with a toe amputation had an average diabetes duration of 19 years;
participants with a BKA had an average diabetes duration of 21 years, and the
participant with an AKA had diabetes for 34 years.
LEA increased the risk of
death, even when diabetes duration was taken into account.
Of the 134 LEAs, 107 were in
Arizona, 14 in the Dakotas and 13 were in Oklahoma. The higher number of LEAs in the Arizona center
may be due to the fact that average diabetes duration was longest in that
center.
These findings highlight the
need for American Indians to control their blood sugar levels and practice
proper foot care in order to prevent damage to the extremities that can lead to
an LEA. In people who already have a
LEA, it is important to control blood sugar levels and seek regular medical
care to control risk factors such as kidney disease, high blood pressure and
high cholesterol. Diabetes prevention
among non-diabetic individuals is also essential.
This investigation, entitled
Prevalence and Long-Term Follow-up of Diabetes-Related Lower Extremity
Amputation in American Indians, is currently being submitted for
publication.
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