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 @ 5:01 AM
Ignite Modification Date:
2025-12-25 @ 5:01 AM
NCT ID:
NCT02715518
Eligibility Criteria:
(1) Inclusion Criteria
1. Subject must be at least 19 years of age
2. Acute ST-segment elevation myocardial infarction (STEMI) A. ※ STEMI: "ST-segment elevation ≥0.1 mV in ≥2 contiguous leads B. or documented newly developed left bundle-branch block "
3. Acute non-ST-segment elevation myocardial infarction (NSTEMI)
A. ※ NSTEMI: NSTEMI is defined as a combination of criteria with mandated elevation of a cardiac biomarker, preferably high-sensitive cardiac troponin with at least one value above 99th percentile of the upper reference limit and at least one of the following:
4. Symptoms of ischaemia.
5. New or presumed new significant ST-T wave changes
6. Development of pathological Q waves on electrocardiography (ECG).
7. Imaging evidence of new or presumed new loss of viable myocardium or regional wall motion abnormality.
8. Intracoronary thrombus detected on angiography.
9. Primary percutaneous coronary intervention (PCI) in \< 12 h after the onset of symptoms for STEMI patients (In case of NSTEMI, PCI should be performed within 72 hours of symptom onset)
10. Multivessel disease (at least one stenosis of \>50% in a non-culprit vessel ≥ 2.0 mm by visual estimation)
11. Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic evaluation and PCI and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
(2) Exclusion criteria
1. Severe stenosis with TIMI flow ≤ II of the non-IRA artery
2. Unprotected left main coronary artery disease (stenosis \> 50% by visual estimation)
3. Non-IRA stenosis not amenable for PCI treatment by operators' decision)
4. Chronic total occlusion in non-IRA
5. Cardiogenic shock (Killip class IV) already at presentation or the completion of IRA PCI
6. Intolerance to Aspirin, Clopidogrel, Plasugrel, Ticagrelor, Heparin, Bivaluridin, or Everolimus, Zotarolimus
7. Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)
8. Pregnancy or breast feeding
9. Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
10. Other primary valvular disease with severe degree: severe mitral regurgitation, mitral stenosis, severe aortic regurgitation, or aortic stenosis
11. Patients with a history of Coronary Artery Bypass Graft (CABG) or treated with fibrinolytic Therapy
12. Unwillingness or inability to comply with the procedures described in this protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT02715518
Study Brief:
Protocol Section:
NCT02715518