Status:
COMPLETED
Effect of Nitric Oxide Donor on Endothelial Progenitor Cells in Patients With Coronary Artery Disease
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
Phase:
PHASE2
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 b...
Detailed Description
Exercise training has long been recommended as a means of improving cardiac function and reducing morbidity and mortality in patients with coronary artery disease (CAD). One mechanism of benefit may b...
Eligibility Criteria
Inclusion
- PATIENT INCLUSION CRITERIA
- 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.
- PATIENT EXCLUSION CRITERIA
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00090558
Start Date
August 1 2004
End Date
September 1 2005
Last Update
March 4 2008
Active Locations (1)
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1
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, United States, 20892