Effect of Nitric Oxide Donor on Endothelial Progenitor Cells in Patients With Coronary Artery Disease

NCT00090558 | Completed Phase 2

• 2 other identifiers: 04026804-H-0268
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Regular exercise reduces the risk of heart problems, in part because it improves the work of the endothelium (the cells that line blood vessels). Exercise appears to release precursor cells from the bone marrow that will later become endothelial cells. A molecule called nitric oxide (NO) appears to be involved in this release. However, some heart patients do not improve their endothelial function despite regular exercise. The researchers believe that the heart disease in these patients may interfere with the normal relationship between exercise and endothelial function. This study is designed to test whether giving a patient nitroglycerin (which is converted to NO in the bloodstream) will increase the release of endothelial precursor cells from the bone marrow. If the study succeeds, it may lead to improved healing of arteries in heart disease patients. Adults may be eligible for this study if they have coronary artery disease and do not take nitroglycerin or nitroglycerin-like medication on a daily basis. Volunteers will be admitted to the Clinical Center on 2 separate nights at least 1 week apart. On the morning after each admission, volunteers will have blood drawn from an arm vein for laboratory tests, and then walk on a treadmill until fatigue or discomfort prevents further exercise, or until asked to stop. On one of their admissions, volunteers will receive 1 tablet of nitroglycerin under the tongue shortly before the treadmill test. Volunteers will be monitored by EKGs and blood pressure tests during the treadmill tests, and will have more blood drawn at about 15 minutes and 24 hours after each treadmill test. Researchers will examine the levels of endothelial precursor cells and nitric oxide in the blood samples taken before and after exercise.

Conditions

Coronary Artery Disease

Keywords

Atherosclerosis; Bone Marrow; Exercise; Endothelium; Nitroglycerin; Coronary Artery Disease; CAD

Interventions

nitroglycerin DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults older than 21 years.
• Coronary artery disease established by angiography.
• No myocardial infarction within 1 month.
• Left ventricular ejection fraction greater than 30%.
• No congestive heart failure symptoms within 2 months.
• No associated medical, neurological or orthopedic condition that might prohibit safe performance of exercise.
• Subject understands protocol and provides written, informed consent in addition to willingness to comply with specified follow-up evaluations.

You may not qualify if:

• Significant structural heart disease (e.g. hypertrophic or dilated cardiomyopathy, valvular heart disease) as determined by echocardiography.
• History of recent (within 2 months) rest or nocturnal angina
• Organic nitrate (e.g., nitroglycerin) use other than study medication within 24 hours of exercise testing
• Hypersensitivity to organic nitrates.
• Women of childbearing age unless recent pregnancy test is negative.
• Lactating women.
• ELIGIBILITY CRITERIA - HEALTHY SUBJECTS
• Healthy subjects must be older than 50 years of age (to approximate the anticipated age of CAD patients), without known CAD, and be free of the following risk factors: blood pressure greater than 140/90 mmHg, fasting glucose greater than 110 mg/dL, smoking, total cholesterol greater than 250 mg/dL. Healthy subjects taking chronic prescription medications will be excluded.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Heart, Lung and Blood Institute (NHLBI)

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis; Motor Activity

Interventions

Nitroglycerin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 27, 2004
• First Posted: August 27, 2004
• Study Start: August 1, 2004
• Study Completion: September 1, 2005
• Last Updated: March 4, 2008

Record last verified: 2005-09

Locations

US (1)