Status:
UNKNOWN
Timing of Complete Revascularization in Patients With ST-segment Elevation Myocardial Infarction And Multivessel Disease
Lead Sponsor:
Beijing Anzhen Hospital
Collaborating Sponsors:
Beijing Chao Yang Hospital
Beijing Luhe Hospital
Conditions:
ST-elevation Myocardial Infarction
Multivessel Coronary Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 S...
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 case...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
426 Patients enrolled
Trial Details
Trial ID
NCT05231226
Start Date
March 1 2022
End Date
December 1 2024
Last Update
February 9 2022
Active Locations (1)
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1
Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100029