Revascularization Strategy of Multivessel Disease for Patients with Acute Myocardial Infarction Complicated by Cardiogenic Shock Undergoing Veno-arterial Extracorporeal Membrane Oxygenator
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 (RESCUE-SHOCK)
Samsung Medical Center
560 participants
Nov 16, 2022
INTERVENTIONAL
Conditions
Summary
This study is a prospective, open-label, two-arm, randomized multicenter trial to identify whether immediate multi-vessel PCI would be better in clinical outcomes compared with culprit lesion-only PCI for AMI and multi-vessel disease with an advanced form of CS patients who require veno-arterial extracorporeal membrane oxygenator (VA-ECMO).
Eligibility
Inclusion Criteria4
- 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.
- Target lesions amenable for planned primary PCI by operators' decision
- Patients with multi-vessel disease
Exclusion Criteria9
- 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.
- Patients with single-vessel disease (Patients with single-vessel disease will be enrolled in the RESCUE-SHOCK registry)
- 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
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Interventions
Randomization will be done after coronary angiography before or during primary PCI for IRA. Patients will be randomized to either immediate multi-vesesl PCI group or culprit-lesion only PCI group with 1:1 ratio. This group will be taken culprit-lesion only PCI during primary PCI.
Randomization will be done after coronary angiography before or during primary PCI for IRA. Patients will be randomized to either immediate multi-vesesl PCI group or culprit-lesion only PCI group with 1:1 ratio. This group will be taken immediate multi-vesesl PCI during primary PCI.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05527717