Timing of FFR-guided PCI for Non-IRA in NSTEMI and MVD (OPTION-NSTEMI)
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0006406
- Lead Sponsor
- Chonnam National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 676
1) Age = 19 years old
2) Non-ST-segment elevation myocardial infarction
** Angina pectoris or equivalent ischemic chest discomfort with at least 1 of 3 features and,
# occurs at rest, usually lasting > 10 minutes
# severe and new onset (within the prior 4-6 weeks)
# crescendo pattern
** Elevated cardiac biomarkers and,
# = 99% value of high-sensitivity cardiac troponin
** No ST-segment elevation = 0.1 mV in = 2 contiguous leads or newly developed left bundle branch block on 12-lead electrocardiogram
3) PCI within 72 hours after symptom development
4) Multivessel disease: Non-IRA with at least 2.5 mm diameter and 50% diameter stenosis by visual estimation
5) Patient's or protector's agreement about study design and the risk of PCI
1) Cardiogenic shock at initial presentation or after treatment of infarct-related artery(IRA)*
2) Thrombolysis in Myocardial Infarction(TIMI) flow at non-IRA = 2 at initial coronary angiography
3) Severe procedural complications (e.g. persistent no-reflow phenomenon, coronary artery perforation) which restricts study enrollment by operators' decision
4) Non-IRA lesion not suitable for percutaneous coronary intervention(PCI) treatment by operators' decision
5) Chronic total occlusion at non-IRA
6) History of anaphylaxis to contrast agent
7) Pregnancy and lactation
8) Life expectancy < 1-year due to non-cardiac disease
9) Severe valvular disease
10) History of coronary artery bypass graft(CABG), or planned CABG
11) Severe asthma
12) Patient's refusal for study participation
* The definition of cardiogenic shock
1) Systolic blood pressure(SBP) < 90mmHg for more than 30min, or needs for vasopressor to maintain equal or more than SBP 90mmHg
2) Pulmonary congestion, or increased left ventricular filling pressure by cardiac catheterization
3) At least one sign of impaired organ perfusion: mental obtundation, pallor, coldness, oliguria, increased blood lactate
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cumulative incidence rate of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization
- Secondary Outcome Measures
Name Time Method Contrast-induced nephropathy;All unplanned revascularization;Target-lesion revascularization;Target-vessel revascularization;Non-target vessel revascularization;All-cause death;Cardiac death;Non-cardiac death;Non-fatal myocardial infarction;Hospitalization for unstable angina;Hospitalization for heart failure;Definite or probable stent thrombosis by ARC definition;Ischemic and hemorrhagic stroke;Major bleeding (BARC classification 3 or 5)