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

OPtimal TIming of Fractional Flow Reserve-Guided Complete RevascularizatiON for Non-Infarct Related Artery in ST-Segment Elevation Myocardial Infarction with Multivessel Disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004457

Enrollment

994

Registered

2019-11-21

Start date

2019-12-30

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : Patients with ST-segment elevation myocardial infarction and multivessel disease will be randomized after primary PCI for IRA. All patients will be randomized to immediate complete

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
A composite of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Korea, Republic of

Contacts

Public ContactMin Chul Kim

Chonnam National University Hospital

kmc3242@hanmail.net+82-62-220-6578

Outcome results