Welcome to the Website of the
Strong Heart Study
Arizona Center and Core Laboratory
Barbara Howard, Ph. D., MedStar Research Institute
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-VI: Lyle Best, M. D., Missouri Breaks Industries Research, Inc.
Oklahoma Center and Coordinating Center
ECG and Ultrasound Reading Center
SHS Genetics Center
Phase III-V: Jean W. MacCluer, Ph.D., Department of Genetics,
Phase V-VI: Shelley Cole, Ph.D., Department of Genetics,
* formerly the Southwest Foundation for Biomedical Research
The organizational chart can be viewed in Appendix 2 of the SHS Operations Manual, Volume 1.
SHS has the following standing committees:
Subcommittees: ( Full list of members can be viewed in Appendix 4 in Volume 1 of the Operations Manual)
Infectious Disease Committee
Morbidity Review Committee
Mortality Review Committee
Publications and Presentations Committee
Quality Control Committee
Renal Disease Committee
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.
Participating communities include 13 American Indian tribes and communities in four states: Arizona, Oklahoma, South Dakota and North Dakota.
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.
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°.
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.
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.
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.
Phase VI will continue the mortality and morbidity surveillance of the original SHS cohort and of the SHFS participants to better understand cardiovascular disease, cancer, liver disease, and inflammation in American Indians. All surviving participants will be invited to participate in Phase VI and fill out a medical history questionnaire after a written consent is given. Their medical records will then be reviewed and pertinent information will be abstracted for morbidity and mortality events that are suspected to relate to the diseases of interest. The abstracted information will then be reviewed by physicians on the Morbidity and Mortality Review Committees to determine whether the event is related to cardiovascular disease, cancer, liver disease, etc. Incidence rates and prevalence proportions of these health conditions as well as their risk factors, including genetic factors, will be determined from analyses of the data collected in Phase VI and those collected in Phases I-V.
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