Endothelial Progenitor Cells and Risk Factors for Coronary Artery Disease

March 3, 2008 updated by: National Heart, Lung, and Blood Institute (NHLBI)

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 subject's 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 subject's tongue. Before the nitroglycerin spray and 3 minutes after it, the size of the artery and blood flow through it are measured again.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Heart, Lung and Blood Institute (NHLBI)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2001

Study Completion

March 1, 2003

Study Registration Dates

First Submitted

April 4, 2001

First Submitted That Met QC Criteria

April 4, 2001

First Posted (Estimate)

April 5, 2001

Study Record Updates

Last Update Posted (Estimate)

March 4, 2008

Last Update Submitted That Met QC Criteria

March 3, 2008

Last Verified

March 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 010119
  • 01-H-0119

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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