The largest epidemiologic study of cardiovascular disease in American Indians

Welcome to the Website of the

Strong Heart Study

 

 

 

 

SHS LOGOhttp://www.ouhsc.edu/graphics/spacer.gif

 

Principal Investigators

Organizational Structure

SHS Directory

Participating Communities

Phase I Exam (SHS-I)

Phase II Exam (SHS-II)

Phase III Exam (SHS-III)

Phase IV Exam (SHS-IV)

Phase V Exam (SHS-V)

Publications

bd15060_ Publications and Presentations Policy and Forms (updated on 6-12-2014) (New)

SHS Databook

SHS Data Request Policy and Form for Ancillary/Sub-Studies (New)

SHS Ancillary/Sub-Studies Guidelines and Proposal Form (.pdf) (New)

SHS Ancillary/Sub-Studies Guidelines and Proposal Form (.docx) (New)

SHS Operations Manual, Forms with Variables

(Phase I, II, III, IV, and V), and Data Dictionaries (Phase I, II, III, and IV)

Hypertension Risk Calculator as a tool for research and community planning

SHS Form(s) and Updates

SHS Slides Presentations & Lab QC Results

SHS Phase V training photo albums

Newsletters

Related Sites

bd15060_SHHS Homepage

bd15060_SHHS Publications

bd15060_Special SHS Links

 

bd14866_The following contents require login:

 

bd15060_Minutes of the Steering Committee Calls and Meetings

 

bd15060_SHS Subcommittee Minutes; Phase VI Planning Calls; SHS SC Correspondence; and SHS OSMB Archive

 

bd15060_Internal Paper Tracking Info and Data Requests

Archives of SHS Educational Resources

 

 

 

 

 

 

 

 

 

Quick Website Update Info: Calculators:

*      Coronary Heart Disease Risk Calculator

*      Diabetes Risk Calculator

sunNew: SHS Publications and Presentations Policy and Forms

sunNew: SHS Ancillary/Sub-Studies Guidelines and Proposal Form (.pdf)

sun SHS Ancillary/Sub-Studies Guidelines and Proposal Form (.docx)

sunNew: Data Request Policy and Forms for Ancillary/Sub-Studies

sunSHS Community Education Brochures

sunSHS Publications

sunSHS Recently Approved Paper/Dissertation/Thesis Proposals

sunSHS Recently Approved Ancillary Studies/Collaborations

sunSHS Newsletters

sunSHS Directory

 

About the Strong Heart Study (SHS)

 

In the early 1980s, a review of existing data by the Subcommittee on Cardiovascular and Cerebrovascular Disease of the Secretary of Health and Human Services Task Force on Black and Minority Health concluded that information on cardiovascular disease (CVD) in American Indians was inadequate and strongly recommended epidemiologic studies of this problem. The Strong Heart Study (SHS) was designed to respond to this recommendation.

 

Cardiovascular disease has become the leading cause of death in American Indians. Major problems such as small community size, relatively young age, cultural diversity, and the geographic dispersion of the American Indian population have made it difficult to determine the prevalence and severity of cardiovascular disease among American Indians.

 

The SHS is a study of cardiovascular disease and its risk factors among American Indian men and women supported by the National Heart, Lung, and Blood Institute (NHLBI) since October 1, 1988 and is the largest epidemiologic study of American Indians ever undertaken. The SHS, which uses standardized methodology, is designed to estimate cardiovascular disease mortality and morbidity and the prevalence of known and suspected cardiovascular disease risk factors in American Indians and to assess the significance of these risk factors in a longitudinal analysis. The study included 13 American Indian tribes and communities in three geographic areas: an area near Phoenix, Arizona, the southwestern area of Oklahoma, and western and central North and South Dakota.

 

In its initial stages, the SHS included three components. The first was a survey to determine cardiovascular disease mortality rates from 1984 to 1994 among tribal members aged 35-74 years of age residing in the 3 study areas (the community mortality study). The second was the clinical examination of 4,500 eligible tribal members. The third component is the morbidity and mortality (M&M) surveillance of these 4,500 participants. The SHS has completed three clinical examinations of the original Cohort (Phase I: 1989-1991; Phase II: 1993-1995; Phase III: 1998-1999, respectively). Due to the importance of genetics in the occurrence of CVD, the SHS expanded into the genetic epidemiology area. In the Phase III study, in addition to the Cohort examination, the study conducted a pilot family study. Each field center recruited about 10 large families. The family pilot study recruited approximately 30 families which consisted of more than 900 family members. Due to the success of the pilot study, Phase IV was funded to conduct a full-blown family study to investigate the heritability of CVD and its risk factors and to localize genes that contribute to CVD risk. A 10-centimorgan map has been constructed and linkage analysis is being performed to assess inheritance of CVD risk factors. In Phase IV, an additional 18 to 25 extended families (a total of about 900 members at least 15 years of age) were recruited from each of the field centers from 2001 2003. This provides a total of 3,776 individuals from 94 families, of whom 825 are Phase III participants re-examined in Phase IV. Click here if you are interested in the SHS genetic study.

 

Phase V of the SHS is pursuing the following aims: 1) Expand the genetic studies that will emphasize the genome scan approach, but also include investigation of carefully selected candidate genes. The completed genome scan of 3,776 members from 94 extended families will be used to localize genes that contribute to CVD susceptibility. We also will examine a selected number of candidate genes that are difficult to implicate on the basis of linkage studies, but are of potential importance to vascular disease. 2) Continue the mortality and morbidity surveillance of the original cohort (2859 male and female survivors, ages 60 89 years) and to initiate annual mortality surveillance and limited morbidity follow-up of the non-cohort family members. 3) Re-examine the family members so that changes in risk factors can be analyzed and genetic effects on changes estimated.

 

Advantages of the SHS include the following: 1) It provides health data on an underserved ethnic group. 2) It is the largest, longest longitudinal study in the US of CVD and its risk factors in individuals with diabetes. 3) Data from cardiac, carotid, and popliteal ultrasound measures will substantially improve understanding of mechanisms of vascular disease in diabetes and the genetics of CVD. 4) This population includes a group in which the epidemic of obesity and diabetes has impacted people at very young ages, permitting analysis of genetic and environmental effects on these conditions with limited confounding by age effects. SHS may lead to valuable therapeutic and prevention strategies for this and other populations in the US and the world, where the epidemics of obesity, diabetes, and CVD are increasing rapidly.

 

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Contact the Strong Heart Study:

 

Center for American Indian Health Research

College of Public Health

University of Oklahoma Health Sciences Center

P.O. Box 26901

Oklahoma City, OK 73190-0901

(405) 271-3090

Toll Free 1-888-231-4671

OUHSC Links

 

OUHSC1

 

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HIPAA Information Website

HIPAA Information Website

View Notice of Privacy Practices (PDF)

 

 

 

 

 

http://www.ouhsc.edu/graphics/spacer.gifPrincipal Investigators

 

Arizona Center and Core Laboratory

Barbara Howard, Ph. D., MedStar Research Institute

 

Dakotas Center

Phase I-II: Thomas K. Welty, M.D., Aberdeen Area Indian Health Service

Phase III: Thomas K. Welty, M.D., Aberdeen Area Tribal Chairmen's Health Board

Phase IV: Lyle Best, M. D., Missouri Breaks Industries Research, Inc.

 

Oklahoma Center and Coordinating Center

Elisa T. Lee, Ph.D., Center for American Indian Health Research (CAIHR), University of Oklahoma Health Sciences Center (OUHSC).

 

ECG and Ultrasound Reading Center

Richard B. Devereux, M.D., Division of Cardiology, the New York Presbyterian Hospital Weill Medical College of Cornell Medical Center.

 

SHS Genetics Center

Phase III-V: Jean W. MacCluer, Ph.D., Department of Genetics, Texas Biomedical Research Institute*

Phase V: Shelley Cole, Ph.D., Department of Genetics, Texas Biomedical Research Institute*

* formerly the Southwest Foundation for Biomedical Research

 

bd14868_For the full list of Principal and Co-Investigators and their contact info, please refer to Appendix I in the SHS Operations Manual, Volume 1

 

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Organizational Structure

 

bd14868_The organizational chart can be viewed in Appendix 2 of the SHS Operations Manual, Volume 1.

 

SHS has the following standing committees:

 

Steering Committee

 

Subcommittees: (bd14868_ Full list of members can be viewed in Appendix 4 in Volume 1 of the Operations Manual)

 

blebul1a Data Committee

blebul1a Ethics Committee

blebul1a Genetic Committee

blebul1a Infectious Disease Committee

blebul1a Morbidity Review Committee

blebul1a Mortality Review Committee

blebul1a Nutrition Committee

blebul1a Psychosocial Committee

blebul1a Publications and Presentations Committee

blebul1a Quality Control Committee

blebul1a Renal Disease Committee

blebul1a Sample Committee

 

bd14868_Other key personnel and consultants and their contact info can be viewed in Appendix 5 and Appendix 6 in the SHS Operations Manual, Volume 1.

 

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Participating Communities

 

Participating communities include 13 American Indian tribes and communities in four states: Seven Tribes from Southwestern Oklahoma (Apache, Caddo, Comanche, Delaware, Fort Sill Apache, Kiowa and Wichita), three tribes from Arizona (Gila River and Salt River Pima/Maricopa, and Akchin Pima/Papago), and three Sioux Tribes from South/North Dakota (SD/ND) (Oglala Sioux, Cheyenne River Sioux, and Spirit Lake Communities).

 

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Phase I Exam (SHS-I, The Baseline Examination)

 

 

The purpose of the Phase I exam was to measure the extent of heart disease and heart disease risk factors among the three SHS centers.

 

The Phase I exam was conducted between 1989 and 1991. 4549 tribal members, ages 45-74 years of age (62% of the total population ages 45-74 yrs) were seen. In the Phase I examination, medical history, family history of related illness, diet, alcohol and tobacco consumption, physical activity, degree of acculturation, and socioeconomic status of the participants were assessed in personal interviews. The physical examination included measurements of body fat, body circumferences, and blood pressure, an examination of the heart and lungs, an evaluation of peripheral vascular disease, and a 12-lead resting electrocardiogram (ECG). Laboratory measurements in the baseline exam included fasting and post-load glucose and fasting insulin, fasting lipids, apoproteins B and AI, apo E phenotype, fibrinogen, Lp(a), LDL size, Gm allotype, and glycated hemoglobin. Measures were also made of urinary creatinine and urinary albumin, and some blood samples were frozen and stored for future analysis.

 

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Phase II Exam (SHS-II)

 

 

Most of the information about factors that increase the risk of heart disease comes from non-Indian populations. We assume that the same factors contribute to heart disease in Indians. To be sure of which factors contribute to heart disease in Indians, it was necessary to do more than one examination. The second examination was conducted to show whether these risk factors change with time. In addition, new measurements were added to increase our understanding of heart disease and lung disease among American Indians. These were the objectives of the second examination the Phase II examination.

 

The Phase II examination was conducted between 1993 and 1995. It re-examined 89% of all surviving members of the original cohort. During the examination, medical history was updated and a 24-hour dietary recall was performed on all individuals. Alcohol consumption and tobacco use were reassessed. The physical examination included measures of body fat, body circumferences and blood pressure, an evaluation of peripheral vascular disease, and a 12-lead resting electrocardiogram (ECG). Measures of pulmonary function, an echocardiogram, and a gallbladder sonogram were added. Laboratory measurements included fasting and post-load glucose, and fasting insulin, fasting lipids, fibrinogen, PAI1, glycated hemoglobin, and urinary albumin and creatinine; red blood cell allotypes were also assessed. Blood samples for future analysis were again stored at -70.

 

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Phase III Exam (SHS-III)

 

 

The Phase III exam was conducted between 1998 and 1999 and 88% of all surviving participants were re-examined. The examination included personal habits and medical history update, twenty-four hour dietary recall, and assessment of alcohol and tobacco consumption. The physical exam included measures of body fat, body circumferences and blood pressure, an evaluation of peripheral vascular disease, and a 12-lead resting electrocardiogram. Ultrasound assessment of the carotid arteries and a measurement of arterial stiffness were added; skin testing and monitoring of pulmonary function were done in those with a history of asthma. Laboratory measurements included fasting and post-load glucose, and fasting insulin, fasting lipids, fibrinogen, PAI1, glycated hemoglobin, and urinary albumin and creatinine, hematocrit and Chemistry Profile (SMAC 12, including electrolytes, BUN, creatinine, total protein, SGPT, and SGOT).

 

Additionally, SHS demonstrated in the Phase III pilot Family Study (May through December 1997) that the study was able to recruit and retain large kindreds from which physiologic measurements were made and blood samples taken for direct genotyping.

 

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Phase IV Exam (SHS-IV)

 

The Phase IV Exam is a continuation and marked expansion of the Family Study initiated in Phase III. Phase IV will recruit and examine 90 more families and perform linkage analysis on a total sample of 3600 individuals including re-examination of the 900 Phase III Family Study participants. The major components of Phase IV include non-invasive carotid ultrasound and pressure waveform analysis, measures of LV structures and function by echocardiography, and laboratory tests (include measures of Thyroid Stimulating Hormone (TSH) and Endothelin and VCAM-1).

 

The Strong Heart Study-IV (SHS, Cardiovascular Disease in American Indians Phase IV) is continuing the mortality and morbidity surveillance of the original cohort, the study of the inheritance of risk factors in American Indian families, and the re-examination of the members of the original families recruited in Phase III.

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Phase V Exam (SHS-V)

 

Phase V of SHS will continue to examine the genetic basis of a wide spectrum of cardiovascular phenotypes to enable quantification of CVD, to assess trends over time in cardiovascular risk factors and CVD events, with focus on diabetes, and to further evaluate the alarming prevalence of diabetes, diabetes-associated risk factors and preclinical CVD in young American Indians. The Phase V Exam is a continuation of the Family Study initiated in Phase III and greatly expanded in Phase IV. In Phase V all family members examined in Phase III and/or Phase IV will be invited to the Phase V exam. This re-examination will incorporate the major components of Phase IV including non-invasive carotid artery ultrasound and measures of the structure and function of the heart by echocardiography. These ultrasound measures will be expanded to include assessment of atherosclerosis in the legs (popliteal artery in the knee area) as an indicator of peripheral artery disease. The laboratory tests will include the usual blood and urine indicators of general and cardiovascular health and will also include new indicators of inflammation (namely, free fatty acids (FFA), C-reactive protein (CRP) and leptin), which appear to be related to obesity, insulin resistance and diabetes, all of which are important risk factors for CVD.

 

In addition to re-examining the members of the original families recruited in Phase III and/or Phase IV, the Strong Heart Study-V (SHS, Cardiovascular Disease in American Indians Phase V) is continuing the mortality and morbidity surveillance of the original SHS cohort, initiating annual mortality surveillance and limited morbidity follow-up of the non-cohort family members, and continuing the study of the inheritance of risk factors in American Indian families.

 

bd14868_For more information on data and results from all five examinations, please refer to our publications, SHS databook, and SHS Operations Manual.

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