OPtimal TIming of Fractional Flow Reserve-Guided Complete RevascularizatiON in ST-Segment Elevation Myocardial Infarctio

Not Applicable

Active, not recruiting

Conditions: Diseases of the circulatory system

Registration Number: KCT0004457

Lead Sponsor: Chonnam National University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Active, not recruiting

Sex: All

Target Recruitment: 994

Inclusion Criteria

1) Age = 19 years old
2) ST-segment elevation myocardial infarction
: ST-segment elevation = 0.1 mV in at least 2 contiguous leads or,
: New onset left bundle branch block
3) Primary PCI within 12 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

Exclusion Criteria

1) Cardiogenic shock at initial presentation or after treatment of IRA
2) Unprotected left main coronary artery disease with at least 50% diameter stenosis by visual estimation
3) TIMI flow at non-IRA = 2
4) Severe procedural complications (e.g. persistent no-reflow phenomenon, coronary artery perforation) which restricts study enrollment by operators’ decision
5) Non-IRA lesion not suitable for PCI treatment by operators’ decision
6) Chronic total occlusion at non-IRA
7) History of anaphylaxis to contrast agent
8) Pregnancy and lactation
9) Life expectancy < 1-year
10) Severe valvular disease
11) History of CABG, or planned CABG
12) Fibrinolysis before admission
13) Severe asthma
14) Patient's refusal to participate in study

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A composite 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);A composite of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization