TERMINAL: Timing of Complete Revascularization in Patients With ST-segment Elevation Myocardial Infarction And Multivessel Disease

Sponsor

Beijing Anzhen Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05231226

Collaborator

Beijing Chao Yang Hospital (Other), Beijing Luhe Hospital (Other)

426

Enrollment

Location

Arms

33.1

Anticipated Duration (Months)

12.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

At present, the two treatment strategies of opening non infarct related arteries (non IRA) simultaneously or by stages after emergency percutaneous coronary intervention (PCI) in patients with acute ST segment elevation myocardial infarction (STEMI) complicated with multi vessel disease (MVD) are still controversial. In our previous retrospective analysis, there was no significant difference between complete revascularization (CR) and staged CR at Anzhen Hospital in the cases of cardiac death, reinfarction, stroke, proportion of revascularization and hospitalization rate of heart failure.

Condition or Disease	Intervention/Treatment	Phase
ST-elevation Myocardial Infarction Multivessel Coronary Disease	Procedure: Immediately CR Procedure: Staged (within 45 days) CR	N/A

Detailed Description

The literature reports on the benefits of two CR strategies of opening non IRA simultaneously or by stages after IRA treatment in STEMI patients are inconsistent. This study intends to enroll 426 cases and divide into two groups to verify whether the occurrence of major cardiovascular adverse events (all-cause death, nonfatal myocardial infarction, ischemia driven revascularization and heart failure) in one year in immediately open non-IRA after successful emergency PCI of infarct related arteries in STEMI patients with MVD group is not inferior to staged (within 45 days) CR group. It can accumulate more evidence-based medical basis for the selection of better treatment schemes, so as to formulate optimized treatment schemes for clinic. To study when to open meaningful non IRA in acute STEMI complicated with MVD is of great guiding significance for CR after acute myocardial infarction. At the same time, it has important social significance and economic value for delaying or preventing cardiovascular events.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

426 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Timing of Complete Revascularization in Patients With ST-segment Elevation Myocardial Infarction And Multivessel Disease-A Multi-center Randomized Controlled Trial

Anticipated Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Immediately CR group Immediately open non-IRA after successful emergency PCI of IRA in STEMI patients with MVD	Procedure: Immediately CR Immediately opening non-IRA after emergency opening IRA in STEMI patients with MVD
Active Comparator: Staged (within 45 days) CR group Strategy of opening non-IRA by stages after emergency PCI of IRA in STEMI patients with MVD	Procedure: Staged (within 45 days) CR Staged opening non-IRA after emergency opening IRA in STEMI patients with MVD

Arm

Intervention/Treatment

Experimental: Immediately CR group

Immediately open non-IRA after successful emergency PCI of IRA in STEMI patients with MVD

Procedure: Immediately CR

Immediately opening non-IRA after emergency opening IRA in STEMI patients with MVD

Active Comparator: Staged (within 45 days) CR group

Strategy of opening non-IRA by stages after emergency PCI of IRA in STEMI patients with MVD

Procedure: Staged (within 45 days) CR

Staged opening non-IRA after emergency opening IRA in STEMI patients with MVD

Outcome Measures

Primary Outcome Measures

Major Adverse Cardiovascular Event [1 year]
Including All-cause death, Ischemia driven revascularization, Nonfatal myocardial infarction and Heart failure

Secondary Outcome Measures

All-cause death [1 year]
All reasons of death
Ischemia driven revascularization [1 year]
Myocardial ischemia needs to revascularize
Nonfatal myocardial infarction [1 year]
A kind of Myocardial infarction which does not lead to death
Heart failure [1 year]
Deterioration of heart function or acute heart failure
Cardiovascular related death [1 year]
Died of cardiovascular diseases
Stent thrombosis [1 year]
Thrombosis in stent
Dialysis or acute renal insufficiency [1 year]
Dialysis or acute renal insufficiency occurred after operation
Bleeding events [1 year]
Bleeding occurred after oral administration of dual antiplatelet drugs

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Onset of the spontaneous acute STEMI (24 hours).
The anatomical structure of coronary artery is suitable for complete revascularization by PCI.
It is suitable for PCI through radial artery or femoral artery.
Be able to fully identify Infarct-related artery（IRA）.
In addition to IRA, in the vessels of lumen diameter is 2.25mm or more, but less than 4.5mm. there is at least one non IRA's stenosis more than 70% observed in both planes, or 50% ~ 69% stenosis and fractional flow reserve (FFR) or Quantitative Flow Ratio (QFR) measured value is 0.80 or less.
After IRA revascularization the thrombolysis in myocardial infarction (TIMI) blood flow is in grade 3.
The hemodynamics of patients after IRA revascularization is stable, that is, systolic blood pressure ≥ 90mmHg, or blood pressure ≥ 90mmHg after catecholamines, and there is no clinical manifestation of hypoperfusion.
Patient who has signed informed consent

Exclusion Criteria:

Cardiogenic shock which means a group of clinical syndromes leading to cardiac dysfunction caused by various reasons, which meet the following criteria: A: continuous hypotension, systolic blood pressure < 90mmHg or mean arterial pressure decreased from baseline ≥ 30mmhg, more than 30min; B: cardiac index < 1.8l/min/m2, pulmonary congestion or elevated left ventricular filling pressure; c: Signs of organ perfusion damage (at least one): changes in mental state, wet and cold skin, oliguria, and increased serum lactic acid level.
The duration of cardiopulmonary resuscitation is more than 10 minutes.
Emergency coronary artery bypass grafting (CABG) is needed.
Previous coronary-artery bypass grafting surgery.
Hybrid revascularization is planned.
Coronary dissection.
Stent thrombosis.
In stent restenosis, definition: A: target vessel diameter stenosis ≥ 50% at follow-up. b: The lumen loss at follow-up was larger than 50% of the net lumen gain after operation. c: The lumen diameter at follow-up and the minimum diameter loss measured immediately at stenting were 0.72 mm or more.
Acute myocardial infarction complicated with severe mechanical complications, defined as acute severe mitral regurgitation, ventricular septal perforation and cardiac free wall rupture / pericardial tamponade.
Severe renal failure (EGFR < 30ml / min) or dialysis treatment is required.
Chronic total occlusion of main coronary artery.
Complex bifurcation lesions requiring dual stent treatment.
Stenosis of Left main coronary artery≥ 50% or stenosis of left anterior descending coronary artery and circumflex coronary artery ≥ 70%.
Coronary, cerebrovascular or peripheral revascularization is planned.
Cardiac surgery or other surgical treatment is planned.
Contraindications to double antibody therapy [aspirin and P2Y12 inhibitor (clopidogrel or ticagrelor) for 3 months.
pregnant woman.
Patient who has participated in other clinical trials.
Life expectancy < 1 year.
Patient who is not suitable for inclusion in the study according to the operator's judgment.