NCT00013975

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2001

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2001

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 4, 2001

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 5, 2001

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
Last Updated

March 4, 2008

Status Verified

March 1, 2003

First QC Date

April 4, 2001

Last Update Submit

March 3, 2008

Conditions

Coronary Arteriosclerosis

Keywords

Framingham Risk ScoringBrachial Artery ReactivityEPC Colony AssayHealthy VolunteerAtherosclerosis Risk FactorsCholesterolHypertensionSmokingDiabetesPostmenopausalHeart Disease Risk FactorsRisk Factors

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Men: aged 21 and above with or without cardiovascular risk factors
  • Women - post menopausal (based on clinical history) with and without cardiovascular risk factors

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Heart, Lung and Blood Institute (NHLBI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Shi Q, Rafii S, Wu MH, Wijelath ES, Yu C, Ishida A, Fujita Y, Kothari S, Mohle R, Sauvage LR, Moore MA, Storb RF, Hammond WP. Evidence for circulating bone marrow-derived endothelial cells. Blood. 1998 Jul 15;92(2):362-7.

    PMID: 9657732BACKGROUND

  • Asahara T, Murohara T, Sullivan A, Silver M, van der Zee R, Li T, Witzenbichler B, Schatteman G, Isner JM. Isolation of putative progenitor endothelial cells for angiogenesis. Science. 1997 Feb 14;275(5302):964-7. doi: 10.1126/science.275.5302.964.

    PMID: 9020076BACKGROUND

  • Ross R. The pathogenesis of atherosclerosis: a perspective for the 1990s. Nature. 1993 Apr 29;362(6423):801-9. doi: 10.1038/362801a0.

    PMID: 8479518BACKGROUND

MeSH Terms

Conditions

Coronary Artery DiseaseHypertensionSmokingDiabetes Mellitus

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesBehaviorGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

April 4, 2001

First Posted

April 5, 2001

Study Start

March 1, 2001

Study Completion

March 1, 2003

Last Updated

March 4, 2008

Record last verified: 2003-03

Locations

US(1)