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 @ 2:21 AM
Ignite Modification Date:
2025-12-25 @ 2:21 AM
NCT ID:
NCT01952834
Eligibility Criteria:
Inclusion Criteria:
1. Age between 40-75 years old
2. Male sex
3. History of known coronary artery disease (by either history of myocardial infarction, angiogram demonstrative \>=50% stenosis in at least 1 major epicardial coronary artery, or a previous stress test that showed evidence of ischemia that has not been revealed to be a false positive test by angiography)
Exclusion Criteria:
1. Unstable angina or myocardial infarction by history, ECG, and/or enzymatic criteria within 1 month of enrollment.
2. Left ventricular dysfunction as defined by an left ventricular ejection fraction documented as \< 45% within 1 year of enrollment by an echocardiogram, MRI, or nuclear imaging.
3. Uncontrolled hypertension with a blood pressure greater than 170/100 mmHg at the screening visit.
4. Known history of chronic renal insufficiency, liver dysfunction, or cancer besides non-melanoma skin carcinomas or localized prostate cancer requiring systemic treatment within five years of enrollment.
5. Known history of cognitive impairment or inability to follow study procedures
6. Patient with an implanted defibrillator or permanent pacemaker on with the potential participant is known to rely upon for greater than 50% of ventricular depolarizations.
7. Patients who received probiotics, prebiotics, and antibiotics in the last 12 weeks.
8. Patients with dosing changes of vasoactive medications and 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors in the 6 weeks prior to enrollment.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT01952834
Study Brief:
Protocol Section:
NCT01952834