Gene-Environment Interactions in Complex Disease
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ClinicalTrials.gov Identifier: NCT00064506 |
Recruitment Status
:
Completed
First Posted
: July 10, 2003
Last Update Posted
: January 15, 2015
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Condition or disease |
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Cardiovascular Diseases Heart Diseases Atherosclerosis Coronary Disease |
BACKGROUND:
Cardiovascular disease (CVD), the number one cause of death in industrialized countries today is a complex disease with a multifactorial etiology involving many genetic and environmental factors. Public health prevention programs designed to reduce the risk and occurrence of CVD commonly focus on modifiable environments and behaviors such as diet and physical activity, with varied results among individuals. This heterogeneity in response to CVD interventions is at least in part of genetic origin. Although a number of candidate genes have been identified which appear to influence the development of CVD, little is known about how these genetic effects may vary within demographic (e.g., race and gender) and environmental (e.g., diet and exercise) contexts; thus, it is of utmost importance to determine how genes and environments interact to produce CVD.
DESIGN NARRATIVE:
The purpose of this study is to characterize the environment-dependent effects of 87 biologic and positional candidate genes in a population-based sample of 11,625 African-American and Caucasian men and women from the Atherosclerosis Risk in Communities (ARIC) study. Candidate loci were selected based on confirmed functional significance, consistent association with CVD or its risk factors, and or identified as positional candidates in genome-wide linkage scans. Environmental contexts will focus on dietary measures (e.g., total kcals, Keys score, alcohol intake), obesity, measures of physical activity (sport, leisure, and work indices), smoking, and menopause status/hormone use (women only). Outcome variables will include measures of quantitative risk factors (e.g., total cholesterol, BMI, blood pressure), subclinical disease (carotid wall thickness), and clinical disease (incident coronary heart disease (CHD) and stroke). Existing DNA samples will be used for genotyping of candidate loci, and no further contact with study participants will be necessary. The ARIC cohort, because of its large size and wealth of environmental and physiological measures, provides an ideal, timely, and efficient opportunity to evaluate the effects of modifiable environments on genetic variation which may influence CVD risk and disease outcomes with the ultimate goal of establishing more efficacious programs for the treatment and prevention of CVD.
Study Type : | Observational |
Actual Enrollment : | 15792 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Gene-Environment Interactions in Complex Disease |
Study Start Date : | July 2003 |
Actual Primary Completion Date : | May 2007 |
Actual Study Completion Date : | May 2007 |


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Ages Eligible for Study: | 45 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00064506
Principal Investigator: | Eric Boerwinkle | University of Texas |
Publications:
Responsible Party: | Eric Boerwinkle, ◦Professor & Director, Division of Epidemiology & Kozmetsky Family Chair In Human Genetics, The University of Texas Health Science Center, Houston |
ClinicalTrials.gov Identifier: | NCT00064506 History of Changes |
Other Study ID Numbers: |
1224 R01HL073366 ( U.S. NIH Grant/Contract ) |
First Posted: | July 10, 2003 Key Record Dates |
Last Update Posted: | January 15, 2015 |
Last Verified: | January 2015 |
Additional relevant MeSH terms:
Cardiovascular Diseases Heart Diseases Atherosclerosis Coronary Disease Coronary Artery Disease |
Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Myocardial Ischemia |