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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: | NCT00005545 |
To determine if risk factors measured in childhood can predict the development of atherosclerotic coronary and carotid artery disease in adulthood.
Condition | Phase |
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Cardiovascular Diseases Heart Diseases Coronary Arteriosclerosis Carotid Artery Diseases |
N/A |
Study Type: | Observational |
Study Start Date: | December 1998 |
Study Completion Date: | May 2009 |
Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
BACKGROUND:
Many young adult subjects have some degree of atherosclerotic coronary and carotid artery disease and experience no symptoms. As time passes, many die suddenly and unexpectedly and only limited therapeutic process begins in youth, a measure of the early manifestations of atherosclerosis may have the potential of identifying subjects at risk for premature coronary and carotid occlusive vascular disease when therapeutic options can be administered. Impaired brachial artery flow mediated dilatory (FMD) capacities have been shown to exist in children and young adults with hypercholesterolemia, hyperhomocysteinemia, diabetes and in those who smoke. Impaired brachial artery FMD has been shown to related to impaired endothelial function, which is an early manifestation of the atherosclerotic process. If impaired brachial artery FMD is a predictor of the process, then it may be used to non-invasively assess atherosclerosis early in its development and to evaluate the effect of therapeutic interventions.
DESIGN NARRATIVE:
In this longitudinal study using previously studied members of the Muscatine study, measurements are made of contemporaneous risk factors, and brachial artery FMD, along with coronary artery calcification (CAC) and carotid artery intimal-medial thickness (IMT) (the latter two established measures of early atherosclerosis) and again three years later. The effort is designed to examine the following hypotheses: 1) Established risk factor levels measured in childhood, adulthood and across the years form childhood through adulthood are predictive of brachial artery flow mediated dilatory (FMD) capacities; 2) Putative risk factor levels measured in adulthood are related to the degree of brachial artery FMD, CAC and carotid artery IMT; 3) Brachial artery FMD, CAC and carotid artery IMTare related in adults; and 4) Brachial artery FMD is predictive of increased carotid artery IMT.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
No eligibility criteria
Study ID Numbers: | 5088 |
Study First Received: | May 25, 2000 |
Last Updated: | May 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00005545 History of Changes |
Health Authority: | United States: Federal Government |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases Central Nervous System Diseases |
Ischemia Arteriosclerosis Brain Diseases Carotid Artery Diseases Cerebrovascular Disorders Coronary Artery Disease |
Arterial Occlusive Diseases Heart Diseases Myocardial Ischemia Nervous System Diseases Vascular Diseases Central Nervous System Diseases Arteriosclerosis |
Brain Diseases Cerebrovascular Disorders Coronary Disease Cardiovascular Diseases Carotid Artery Diseases Coronary Artery Disease |