Status:
COMPLETED
Biomarkers for Cardiovascular Disease
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
21+ years
Brief Summary
Biomarkers for Cardiovascular Disease Summary: This study will examine the function of the lining cells of blood vessels and measure substances in the blood to see how they relate to various blood te...
Detailed Description
Cardiovascular events are a major cause of morbidity and mortality world-wide and traditional risk factor assessment is limited in its ability to predict which patients will have an event. The endothe...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Adults older than 21, of both sexes:
- The initial study group will consist of 120 subjects, which will consist of 100 subjects with documented CAD (by cardiac catheterization showing greater than or equal to 70% stenosis in an epicardial vessel), previously documented MI (based on ECG or cardiac enzymes) or CAD risk equivalents (diabetes, peripheral vascular disease, abdominal aortic aneurysm, symptomatic carotid disease, or multiple risk factors that confer a 10 year risk of greater than 20% as defined by the Framingham Risk Score) and 20 healthy age- and sex-matched controls.
- Written informed consent.
- EXCLUSION CRITERIA
- Atrial fibrillation
- Any contraindications to oral nitrates
- Hypotension, bradycardia.
- Myocardial infarction within the prior 30 days
- Symptoms of acute CHF
- Pregnant women
- Receiving active treatment for cancer
- Any other condition that may interfere with the interpretation of the study results or not be in the best interest of the subject in the opinion of the investigator.
- Since oral nitrate therapy is known to affect serum and possibly whole blood nitrite levels, we will exclude patients on long-acting nitrates for the initial group of 100 cardiac patients. Those patients on chronic nitrate therapy will subsequently be included in the later portion of the study but will be analyzed separately.
Exclusion
Key Trial Info
Start Date :
April 19 2005
Trial Type :
OBSERVATIONAL
End Date :
April 15 2009
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00109018
Start Date
April 19 2005
End Date
April 15 2009
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892