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RECRUITINGPhase 4INTERVENTIONAL

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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. * Target lesions amenable for planned primary PCI by operators' decision * Patients with multi-vessel disease 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. * 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

Treatments Being Tested

PROCEDURE

Culprit lesion only 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 culprit-lesion only PCI during primary PCI.

PROCEDURE

Immediate multi-vessel 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)

Samsung Medical Center
Seoul, South Korea