Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00013975
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2001-04-04
Brief Title:
Endothelial Progenitor Cells and Risk Factors for Coronary Artery Disease
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Endothelial Progenitor Cells and Risk Factors for Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2003-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Medical history and physical examination
Blood tests to measure EPC level and various risk and growth factors
Brachial reactivity study - This ultrasound study tests how well the subjects arteries widen The subject rests on a bed for 30 minutes An ultrasound measuring device is placed over the artery just above the elbow The size of the artery and blood flow through it are measured before and after inflating a pressure cuff around the forearm The pressure cuff stops the flow of blood to the arm for a few minutes After a 15-minute rest the drug nitroglycerin is sprayed under the subjects tongue Before the nitroglycerin spray and 3 minutes after it the size of the artery and blood flow through it are measured again
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
Medical history and physical examination
Blood tests to measure EPC level and various risk and growth factors
Brachial reactivity study - This ultrasound study tests how well the subjects arteries widen The subject rests on a bed for 30 minutes An ultrasound measuring device is placed over the artery just above the elbow The size of the artery and blood flow through it are measured before and after inflating a pressure cuff around the forearm The pressure cuff stops the flow of blood to the arm for a few minutes After a 15-minute rest the drug nitroglycerin is sprayed under the subjects tongue Before the nitroglycerin spray and 3 minutes after it the size of the artery and blood flow through it are measured again
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-H-0119 | None | None | None |