Actively Recruiting

Phase 4
Age: 19Years +
All Genders
ID05527717

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)

Led by Samsung Medical Center · Updated on 2024-11-06

560

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the best revascularization approach for patients with acute myocardial infarction (AMI) complicated by cardiogenic shock (CS) who require veno-arterial extracorporeal membrane oxygenator (VA-ECMO). This trial compares whether performing immediate multi-vessel percutaneous coronary intervention (PCI) leads to better clinical outcomes than treating only the culprit lesion in patients with multi-vessel coronary artery disease and advanced CS. The study addresses ongoing uncertainty about the benefits of non-culprit artery treatment in this high-risk patient group. Participants will be randomly assigned to one of two groups: one receiving PCI only on the culprit lesion, and the other undergoing immediate PCI on multiple vessels during the primary procedure. Randomization occurs after coronary angiography before or during primary PCI for the infarct-related artery. Both treatment approaches are performed during the primary PCI procedure while patients are supported by VA-ECMO. During the study, participants will be closely monitored for outcomes such as rates of death or advanced heart failure requiring cardiac replacement therapy within 90 days after PCI. Additional assessments include in-hospital mortality, success and timing of VA-ECMO weaning, complications, lengths of ICU stay, and various cardiac events up to 12 months after PCI. Researchers will gather detailed clinical data to evaluate safety and effectiveness, with overall participation lasting at least 90 days following the primary intervention.

CONDITIONS

Brief Title

Revascularization Strategy of Multivessel Disease for Patients with Acute Myocardial Infarction Complicated by Cardiogenic Shock Undergoing Veno-arterial Extracorporeal Membrane Oxygenator

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 19 years old
  • Diagnosed with acute myocardial infarction (STEMI or NSTEMI) complicated by cardiogenic shock classified as SCAI Shock C, D, or E
  • Require veno-arterial extracorporeal membrane oxygenator (VA-ECMO) support
  • Have coronary artery lesions suitable for planned primary PCI
  • Have multi-vessel coronary artery disease
Not Eligible

You will not qualify if you...

  • Shock caused by hypovolemia, sepsis, or obstructive reasons
  • Shock due to mechanical complications of myocardial infarction (papillary muscle, ventricular septum, or free wall rupture)
  • Unwitnessed out-of-hospital cardiac arrest with Glasgow coma scale less than 8 after return of circulation
  • Single-vessel coronary artery disease
  • Onset of shock more than 24 hours before
  • Known intolerance to heparin
  • Severe other diseases limiting life expectancy to less than 6 months
  • Pregnancy or breastfeeding
  • Have a do not resuscitate wish

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Immediate during hospital stay

Participants undergo primary percutaneous coronary intervention (PCI) with either culprit-lesion only PCI or immediate multi-vessel PCI while receiving veno-arterial extracorporeal membrane oxygenator (VA-ECMO) support.

1 procedure visit

Follow-up

Duration - Up to 12 months after primary PCI

Participants are monitored for clinical outcomes including mortality, heart failure, and revascularization events after the PCI procedure.

Visits at 30 days, 90 days, and 12 months after primary PCI

Trial Site Locations

Total: 1 location

1

Samsung Medical Center

Seoul, South Korea, 06351

Actively Recruiting

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Research Team

J

Jeong Hoon Yang, MD

K

Ki Hong Choi, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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