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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00664040 |
Cardiovascular disease (CVD) is the leading cause of death in the United States and many people that die of heart disease have no previous symptoms. This study will look specifically at the response to four short-term environmental exposures including: the body's response to a cold stimulus, to a high fat milk shake, to aspirin, and to a high and low salt diet. These interventions are all known to influence CVD and people can have different responses to these interventions, which may be due, at least in part, to differences in genetic make up.
Condition | Intervention |
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Cardiovascular Diseases |
Other: Aspirin Other: Cold Pressor Test Other: High Fat Meal Other: Dietary Salt |
Study Type: | Interventional |
Study Design: | Basic Science, Open Label, Single Group Assignment |
Official Title: | Heredity and Phenotype Intervention (HAPI) Heart Study |
Enrollment: | 868 |
Study Start Date: | May 2003 |
Study Completion Date: | August 2006 |
Nearly one million Americans died of CVD in 1999, and it is predicted that, over one million Americans will have a myocardial infarction (MI) with 650,000 of these experiencing their first MI. Coronary artery disease (CAD) is the leading cause of mortality in the U.S., accounting for 1 of every 5 deaths, or 680,000 of more than 2,000,000 deaths. CAD is also the leading cause of premature, permanent disability in the U.S. labor force, accounting for more than $110 billion in health care costs annually, as compared to $329 billion for all CVD. Risk factors for CAD include high blood pressure, tobacco smoke, abnormal lipids and lipoproteins, physical inactivity, overweight and obesity, diabetes mellitus, increasing age, male sex, heredity, individual response to stress, and menopause in women. Other indicators for increased risk of events include the presence and extent of coronary artery calcification, endothelial dysfunction, and platelet aggregation. Of those who die suddenly from CAD, 50% of men and 63% of women have no previous symptoms. Studies of how specific environmental interventions may interact with genes to influence selected risk factors, especially in individuals with varying extent of vascular calcification, a marker of atherosclerosis, will facilitate the early identification of asymptomatic high-risk individuals who will benefit from existing or new interventions.
The overall objective of this proposal is to identify novel loci (and ultimately genes) that interact with specific environmental exposures to modify risk factors for cardiovascular disease (CVD). To achieve this goal, we will perform four short-term interventions known to modify CVD risk in participants of the Amish Family Calcification Study (AFCS), an ongoing study of the joint genetic determinants of CVD and osteoporosis. Over 1,000 individuals from this ongoing study have already been recruited and are being characterized with respect to CVD risk factors, including blood pressure, body composition, lipids, and coronary artery calcification (by electron beam computerized tomography (EBCT)). From a previous examination, DNA has been collected on all AFCS subjects and a 5-cM genome scan (~800 short tandem repeat (STR) markers) has been completed by the NHLBI Mammalian Genotyping Service. Thus, this large family study from a unique genetically homogeneous founder population provides an ideal opportunity to identify genes that interact with the environment in shaping risk factors for CVD. The Specific Aims of this proposal are:
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Participant of Amish Family Calcification Study or related to a AFCS participant and at least 20 years old.
Exclusion Criteria:
Excluded for the entire study if the subject-
Excluded from the Cold Pressor Test if the subject-
1. Has Raynaud's disease or symptoms
Excluded from the High Fat Challenge if the subject-
Excluded from the Dietary Salt Intervention if the subject-
Excluded from the Aspirin Intervention if the subject-
Study ID Numbers: | 1404, U01 HL072515-05, H-22773 |
Study First Received: | April 18, 2008 |
Last Updated: | April 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00664040 |
Health Authority: | United States: Federal Government |
Aspirin |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Hematologic Agents Physiological Effects of Drugs Enzyme Inhibitors Fibrinolytic Agents Cardiovascular Agents Pharmacologic Actions Fibrin Modulating Agents |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Platelet Aggregation Inhibitors Cardiovascular Diseases Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |