Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT00109018
Eligibility Criteria:
* 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT00109018
Study Brief:
Protocol Section:
NCT00109018