REvaSCUlarization StratEgy of Multivessel Coronary Artery Disease for Patients with Acute Myocardial Infarction Complicated by Cardiogenic SHOCK Undergoing Veno-arterial Extracorporeal Membrane Oxygenator: Randomized-Controlled Trial

Not Applicable

• Conditions: Diseases of the circulatory system

• Registration Number: KCT0007715
• Lead Sponsor: Samsung Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 October 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

(1) Randomization inclusion criteria
?Subject must be at least 19 years of age.
?Patients presented with AMI (ST-segment elevation MI [STEMI] or non-ST-segment elevation MI [NSTEMI]) complicated by CS (SCAI Shock classification C, D or E) * who requiring VA-ECMO.
- Classic CS (Stage C) was defined as the following criteria.
Systolic blood pressure less than 90 mmHg for more than 30 min or catecholamines required to maintain pressure more than 90 mmHg during systole with signs of organ failure (A or B)
A. Sign of pulmonary congestion
B. Sign of impaired organ perfusion with at least one of the following:
a) altered mental status.
b) cold, clammy skin and extremities.
c) oliguria with urine output < 30mg/h.
d) serum lactate > 2.0 mmol/l.
- SCAI Shock classification D is defined as failure to respond to initial interventions with clinical deterioration of classic CS or SCAI Shock classification E is defined as cardiac arrest with ongoing cardiopulmonary resuscitation requiring VA-ECMO insertion.
?Target lesions amenable for planned primary PCI by operators’ decision
?Patients with multi-vessel disease*

(2) Registry inclusion criteria
?Subject must be at least 19 years of age.
?Patients presented with AMI (ST-segment elevation MI [STEMI] or non-ST-segment elevation MI [NSTEMI]) complicated by CS (SCAI Shock classification C, D or E) * who requiring VA-ECMO.
- Classic CS (Stage C) was defined as the following criteria.
Systolic blood pressure less than 90 mmHg for more than 30 min or catecholamines required to maintain pressure more than 90 mmHg during systole with signs of organ failure (A or B)
A. Sign of pulmonary congestion
B. Sign of impaired organ perfusion with at least one of the following:
a) altered mental status.
b) cold, clammy skin and extremities.
c) oliguria with urine output < 30mg/h.
d) serum lactate > 2.0 mmol/l.
- SCAI Shock classification D is defined as failure to respond to initial interventions with clinical deterioration of classic CS or SCAI Shock classification E is defined as cardiac arrest with ongoing cardiopulmonary resuscitation requiring VA-ECMO insertion.
?Target lesions amenable for planned primary PCI by operators’ decision
?Patients with single-vessel disease*

Exclusion Criteria

(1)Common exclusion criteria
?Other causes of shock (hypovolemia, sepsis, obstructive shock).
?Shock due to mechanical complication to MI (rupture of papillary muscle, the ventricular septum, or free wall).
?Unwitnessed out of hospital cardiac arrest with persistent Glasgow coma scale <8 after the return of spontaneous circulation.
?Onset of shock >24 hours.
?Known heparin intolerance.
?Other severe concomitant disease with limited life expectancy < 6 months
?Pregnancy or breast feeding
?Do not resuscitate wish.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
all-cause mortality or advanced heart failure requiring cardiac replacement therapy

Secondary Outcome Measures

Name	Time	Method
In-hospital mortality, In-hospital cardiac mortality, VA-ECMO weaning success, Time to VA-ECMO weaning, Critical limb ischemia after successful VA-ECMO weaning, CPC 3-5, Length of intensive-care unit stay, Total procedural time, Total amount of contrast use, Follow-up all-cause mortality, Follow-up cardiac mortality, Requirement of cardiac replacement therapy, Requirement of renal replacement therapy, Follow-up recurrent spontaneous MI, Follow-up MI related to culprit vessel Follow-up MI related to non-culprit vessel, Follow-up ARC-defined definite or probable stent thrombosis, Follow-up re-hospitalization due to heart failure, Follow-up re-hospitalization due to any cause, Follow-up target lesion revascularization, Follow-up target vessel revascularization, Follow-up repeat revascularization, Follow-up cerebrovascular accident, Follow-up bleeding (BARC type 2, 3, or 5), Follow-up major bleeding (BARC type 3, or 5)