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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00013975 |
This study will measure and compare the levels of endothelial progenitor cells (EPCs) in the blood of people with and without risk factors for atherosclerosis (hardening of the arteries) to see if there is a relationship between these cells and cardiovascular risk factors such as smoking, high cholesterol level and high blood pressure.
Healthy male volunteers between the ages of 21 and 55 years with and without heart disease risk factors may be eligible for this study. Candidates must have no evidence of coronary or peripheral vascular disease, proliferative retinopathy, or other chronic disease and no history of cancer, migraine-type headache, cluster headache, raised intraocular pressure, raised intracranial pressure, hyperthyroidism.
Participants will undergo the following procedures at the NIH Clinical Center:
Condition |
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Coronary Arteriosclerosis |
Study Type: | Observational |
Official Title: | Endothelial Progenitor Cells and Risk Factors for Coronary Artery Disease |
Estimated Enrollment: | 120 |
Study Start Date: | March 2001 |
Estimated Study Completion Date: | March 2003 |
Evidence suggests that risk factors for atherosclerosis contribute to atherogenesis by causing endothelial injury. However, little is known about determinants of endothelial cell repair and regeneration. We propose that mobilization of endothelial progenitor cells (EPCs) constitutes one mechanism for ongoing endothelial repair. EPCs are a bone marrow derived cell population that can be isolated from peripheral blood. Among human peripheral mononuclear cells, EPCs are relatively abundant with an estimated frequency of 1 in 500 to 1 in 1000 cells. Evidence suggests that EPCs can participate in angiogenesis under pathophysiological circumstances. Under normal conditions, however, adult organisms undergo little if any active angiogenesis.
One explanation for this set of observations is that high circulating levels of EPCs may exist to allow these cells to participate in functions beyond angiogenesis. We hypothesize that one such function is in the repair of ongoing endothelial injury. To test this hypothesis, we will measure peripheral blood EPC activity by ascertaining the number of EPC colony forming units from peripheral blood sampling. We intend to correlate this biological determinant with the degree of endothelial dysfunction assessed by flow-mediated brachial artery reactivity, and an atherosclerotic risk stratification method developed by the Framingham study. We hypothesize that a correlation will exist between the atherosclerotic risk profile, endothelial function and EPC activity and that the EPC activity will therefore become a novel surrogate biological marker for cumulative cardiovascular risk.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
Men: aged 21 and above with or without cardiovascular risk factors
Women - post menopausal (based on clinical history) with and without cardiovascular risk factors
EXCLUSION CRITERIA:
Pre-menopausal women
History of cancer
Evidence of proliferative retinopathy
History of migraine-type headache
History of cluster headache
History of raised intraocular pressure
History of raised intracranial pressure
Hypersensitivity to organic nitrates
History of hyperthyroidism
Any intercurrent illness
Any other chronic disease not including cardiovascular risk factors.
No current medications including vitamins for at least 1 week.
Study ID Numbers: | 010119, 01-H-0119 |
Study First Received: | April 4, 2001 |
Last Updated: | March 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00013975 History of Changes |
Health Authority: | United States: Federal Government |
Framingham Risk Scoring Brachial Artery Reactivity EPC Colony Assay Healthy Volunteer Atherosclerosis Risk Factors Cholesterol |
Hypertension Smoking Diabetes Postmenopausal Heart Disease Risk Factors Risk Factors |
Atherosclerosis Arterial Occlusive Diseases Heart Diseases Myocardial Ischemia Diabetes Mellitus Vascular Diseases Arteriosclerosis |
Ischemia Healthy Coronary Disease Smoking Coronary Artery Disease Hypertension |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Cardiovascular Diseases Arteriosclerosis Coronary Artery Disease |