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:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT01484912
Eligibility Criteria:
Inclusion criteria:
1. Male or female aged \> 20;
2. Patients who had effort-induced angina which was relieved by rest or nitroglycerin, or who had catheterization-documented coronary artery disease or previous myocardial infarction ≥ 3 months before screening;
3. Patients who manifested positive ETT (exercise tolerance testing) (defined as ST-segment depression ≥ 1 mm compared with at rest, with or without limiting angina) at screening (Day -7);
4. Patients who manifested positive ETT (exercise tolerance testing) (defined as ST-segment depression ≥ 1 mm compared with at rest, with or without limiting angina) on the day of enrollment (Day 0). ETT performance between Day -7 and Day 0 were required not differ by \>20% in total exercise time;
5. Female patient who was in the post-menopausal stage or of childbearing potential who:
* used adequate contraception since last menstruation and no plan for conception during the study;
* was non-lactating;
* had negative pregnancy test (urine) within 14 days prior to the study;
6. Able to provide written informed consent.
Exclusion criteria:
1. Patients with pre-excitation, conduction abnormalities, pacemaker rhythm, unstable angina or myocardial infarction within the preceding 3 months;
2. Patients with heart failure (New York Heart Association class III or IV), uncorrected valvular or congenital heart disease, patients who needed digoxin, isosorbide mononitrate, nitroglycerin sustained release preparation, theophylline, class I antiarrhythmic agents, digitalis, or monoamine oxidase inhibitors, as judged by the investigator;
3. Patients with any EKG abnormalities preventing the interpretation of ischemia (complete left bundle branch block);
4. Patients with Chronic Obstructive Pulmonary Disease (COPD) requiring bronchodilators;
5. Patients with hepatic failure (defined as aspartate transaminase (AST) and/or alanine transaminase (ALT) \> 3X the upper limit of normal values), and/or renal failure (defined as serum creatinine \> 3 mg/dL);
6. Patients with severe gastrointestinal illness as judged by the investigator;
7. Patient with any conditions that interfered the performance of exercise tolerance test as judged by investigator (e.g., knee/ankle arthropathy, Parkinsonism, stroke).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01484912
Study Brief:
Protocol Section:
NCT01484912