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

Primary Purpose

ST-elevation Myocardial Infarction, Multivessel Coronary Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Immediately CR
Staged (within 45 days) CR
Sponsored by
Beijing Anzhen Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST-elevation Myocardial Infarction focused on measuring Acute ST segment elevation myocardial infarction, Multi vessel lesions, Complete revascularization, Non infarct related arteries, Major cardiovascular adverse events

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Onset of the spontaneous acute STEMI (24 hours).
  2. The anatomical structure of coronary artery is suitable for complete revascularization by PCI.
  3. It is suitable for PCI through radial artery or femoral artery.
  4. Be able to fully identify Infarct-related artery(IRA).
  5. 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.
  6. After IRA revascularization the thrombolysis in myocardial infarction (TIMI) blood flow is in grade 3.
  7. 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.
  8. Patient who has signed informed consent

Exclusion Criteria:

  1. 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.
  2. The duration of cardiopulmonary resuscitation is more than 10 minutes.
  3. Emergency coronary artery bypass grafting (CABG) is needed.
  4. Previous coronary-artery bypass grafting surgery.
  5. Hybrid revascularization is planned.
  6. Coronary dissection.
  7. Stent thrombosis.
  8. 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.
  9. Acute myocardial infarction complicated with severe mechanical complications, defined as acute severe mitral regurgitation, ventricular septal perforation and cardiac free wall rupture / pericardial tamponade.
  10. Severe renal failure (EGFR < 30ml / min) or dialysis treatment is required.
  11. Chronic total occlusion of main coronary artery.
  12. Complex bifurcation lesions requiring dual stent treatment.
  13. Stenosis of Left main coronary artery≥ 50% or stenosis of left anterior descending coronary artery and circumflex coronary artery ≥ 70%.
  14. Coronary, cerebrovascular or peripheral revascularization is planned.
  15. Cardiac surgery or other surgical treatment is planned.
  16. Contraindications to double antibody therapy [aspirin and P2Y12 inhibitor (clopidogrel or ticagrelor) for 3 months.
  17. pregnant woman.
  18. Patient who has participated in other clinical trials.
  19. Life expectancy < 1 year.
  20. Patient who is not suitable for inclusion in the study according to the operator's judgment.

Sites / Locations

  • Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immediately CR group

Staged (within 45 days) CR group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 30, 2021
Last Updated
February 8, 2022
Sponsor
Beijing Anzhen Hospital
Collaborators
Beijing Chao Yang Hospital, Beijing Luhe Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05231226
Brief Title
Timing of Complete Revascularization in Patients With ST-segment Elevation Myocardial Infarction And Multivessel Disease
Acronym
TERMINAL
Official Title
Timing of Complete Revascularization in Patients With ST-segment Elevation Myocardial Infarction And Multivessel Disease-A Multi-center Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2022 (Anticipated)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Anzhen Hospital
Collaborators
Beijing Chao Yang Hospital, Beijing Luhe Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST-elevation Myocardial Infarction, Multivessel Coronary Disease
Keywords
Acute ST segment elevation myocardial infarction, Multi vessel lesions, Complete revascularization, Non infarct related arteries, Major cardiovascular adverse events

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
426 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediately CR group
Arm Type
Experimental
Arm Description
Immediately open non-IRA after successful emergency PCI of IRA in STEMI patients with MVD
Arm Title
Staged (within 45 days) CR group
Arm Type
Active Comparator
Arm Description
Strategy of opening non-IRA by stages after emergency PCI of IRA in STEMI patients with MVD
Intervention Type
Procedure
Intervention Name(s)
Immediately CR
Intervention Description
Immediately opening non-IRA after emergency opening IRA in STEMI patients with MVD
Intervention Type
Procedure
Intervention Name(s)
Staged (within 45 days) CR
Intervention Description
Staged opening non-IRA after emergency opening IRA in STEMI patients with MVD
Primary Outcome Measure Information:
Title
Major Adverse Cardiovascular Event
Description
Including All-cause death, Ischemia driven revascularization, Nonfatal myocardial infarction and Heart failure
Time Frame
1 year
Secondary Outcome Measure Information:
Title
All-cause death
Description
All reasons of death
Time Frame
1 year
Title
Ischemia driven revascularization
Description
Myocardial ischemia needs to revascularize
Time Frame
1 year
Title
Nonfatal myocardial infarction
Description
A kind of Myocardial infarction which does not lead to death
Time Frame
1 year
Title
Heart failure
Description
Deterioration of heart function or acute heart failure
Time Frame
1 year
Title
Cardiovascular related death
Description
Died of cardiovascular diseases
Time Frame
1 year
Title
Stent thrombosis
Description
Thrombosis in stent
Time Frame
1 year
Title
Dialysis or acute renal insufficiency
Description
Dialysis or acute renal insufficiency occurred after operation
Time Frame
1 year
Title
Bleeding events
Description
Bleeding occurred after oral administration of dual antiplatelet drugs
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaotong Hou, MD,PhD
Phone
8610 64456631
Email
xt.hou@ccmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hou
Organizational Affiliation
Beijing Anzhen Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
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Timing of Complete Revascularization in Patients With ST-segment Elevation Myocardial Infarction And Multivessel Disease

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