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Clinical Trials in South Korea / NCT07741721
Starting soon Not applicable

Optimal Timing of Staged Complete Revascularization in STEMI With Multivessel Disease

NCT07741721 · tracked via the Priya Life Science South Korea tracker
Sponsor
Chonnam National University Hospital
Phase
Not applicable
Started
2026-09-01
Last updated
2026-08-17

Condition(s) studied

Myocardial Infarction (MI)

Investigational drug(s) / intervention(s)

In-hospital staged complete revascularizationOut-of-hospital staged complete revascularization

In-hospital staged complete revascularization: PCI of non-IRA lesions will be performed on a separate day during the index hospitalization, at least 48 hours after PCI of the IRA. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without FFR evaluation. Non-IRA lesion with diameter stenosis 50-69% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion will be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized.

Out-of-hospital staged complete revascularization: PCI of non-IRA lesions will be performed after discharge and between 15 and 45 days of randomization. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without FFR evaluation. Non-IRA lesion with diameter stenosis 50-69% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion will be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized.

Study summary

This prospective, multicenter, open-label, superiority trial will enroll patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease. Following successful percutaneous coronary intervention (PCI) of the infarct-related artery (IRA), patients who meet the eligibility criteria will be randomized in a 1:1 ratio to either in-hospital staged complete revascularization with PCI of non-IRA lesions performed on a separate day during hospitalization, at least 48 hours after PCI of the IRA, or out-of-hospital staged complete revascularization with PCI of non-IRA lesions performed after discharge between 15 and 45 days of randomization. In both groups, non-IRA lesions with 50-69% stenosis will be evaluated using FFR.

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥19 years * ST-segment elevation myocardial infarction (STEMI): ST-segment elevation ≥ 0.1 mV in at least two contiguous leads, or New-onset left bundle branch block (LBBB) * Primary PCI within 12 h after symptom development * At least 1 non-infarct related artery (non-IRA) with diameter ≥ 2.5 mm and 50% stenosis by visual estimation Exclusion Criteria: * Cardiogenic shock at initial presentation or after infarct-related artery (IRA) treatment * Thrombolysis in myocardial infarction flow at non-IRA ≤ 2 * Severe procedural complications during primary percutaneous coronary intervention that, in the judgement of the operator, preclude study enrollment * Non-IRA lesion unsuitable for percutaneous coronary intervention (PCI) treatment that, in the judgement of the operator, preclude study enrollment * Chronic total occlusion in a non-IRA * History of anaphylaxis to contrast agent * Pregnancy and lactation * Life expectancy \< 1 year * Severe valvular heart disease * History of coronary artery bypass grafting (CABG) or planned CABG * Fibrinolysis therapy prior to admission * Severe asthma

Primary outcome measure(s)

  • Composite of all-cause death, nonfatal myocardial infarction, or all unplanned revascularization — At 12 months after randomization

Trial sites (30)

FacilityCityRegionStatus
Bucheon Sejong Hospital Bucheon-si South Korea
Gyeongsang National University Changwon Hospital Changwon South Korea
Samsung Changwon Medical Center Changwon South Korea
Soon Chun Hyang University Hospital Cheonan Cheonan South Korea
Chungbuk National University Hospital Cheongju-si South Korea
Kangwon National University Hospital Chuncheon South Korea
Daegu Catholic University Medical Center Daegu South Korea
Keimyung University Dongsan Hospital Daegu South Korea
Kyungpook National University Hospital Daegu South Korea
Yeongnam University Medical Center Daegu South Korea
Chungnam National University Hospital Daejeon South Korea
Chonnam National University Hospital Gwangju South Korea
Chosun University Hospital Gwangju South Korea
Gwangju Veterans Hospital Gwangju South Korea
Kwangju Christian Hospital Gwangju South Korea
Chung-Ang University Gwangmyeong Hospital Gwangmyeong South Korea
Jeju National University Hospital Jeju City South Korea
Jeonbuk National University Hospital Jeonju South Korea
Presbyterian Medical Center Jeonju South Korea
Gyeongsang National University Hospital Jinju South Korea
Inje University Busan Paik Hospital Pusan South Korea
Inje University Haeundae Paik Hospital Pusan South Korea
Kosin University Gospel Hospital Pusan South Korea
Pusan National University Hospital Pusan South Korea
Koera University Guro Hospital Seoul South Korea
Korea University Anam Hospital Seoul South Korea
Yonsei University Health System, Gangnam Severance Hospital Seoul South Korea
St. Carollo General Hospital Suncheon South Korea
Ajou University Hospital Suwon South Korea
Pusan National University Yangsan Hospital Yangsan South Korea

More Chonnam National University Hospital trials in South Korea

Timing of FFR-guided PCI for Non-IRA in STEMI and MVD (OPTION-STEMI) Active, not recruiting
Timing of FFR-guided PCI for Non-IRA in NSTEMI and MVD (OPTION-NSTEMI) Recruiting
Abbreviated Antithrombotic Therapy After PCI in Patients With AF and AMI Recruiting
Imaging and Physiologic Evaluation of Coronary Artery Disease Recruiting
PREcise Percutaneous Coronary Intervention for Stent OptimizatION in Treatment of COMPLEX Lesion (PRECISION-COMPLEX) Active, not recruiting

Other trials for the same condition

Abbreviated Antithrombotic Therapy After PCI in Patients With AF and AMI Recruiting
Timing of Coronary Angiography in NSTEMI Complicated by Acute HF Recruiting
Optimal Timing of Microaxial Flow Pump(Impella CP) in AMI-related Cardiogenic Shock Starting soon
The Rule-Out Acute Myocardial Infarction Using Aritifical Intelligence Electrocardiogram (ROMIAE) 2 Trial Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07741721 on ClinicalTrials.gov ↗ ← All trials in South Korea