Comparing revascularization strategies for heart attack patients with cardiogenic shock
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)
This study is testing whether treating multiple blocked heart arteries right away helps heart attack patients in shock feel better compared to just fixing the main blockage.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 560 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Samsung Medical Center Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05527717 on ClinicalTrials.gov |
What this trial studies
This study is a prospective, open-label, two-arm, randomized multicenter trial aimed at determining whether immediate multi-vessel percutaneous coronary intervention (PCI) leads to better clinical outcomes compared to treating only the culprit lesion in patients with acute myocardial infarction (AMI) complicated by cardiogenic shock who require veno-arterial extracorporeal membrane oxygenation (VA-ECMO). The trial addresses the critical decision-making process regarding revascularization strategies in patients with multi-vessel disease, as current guidelines suggest caution in performing non-infarct related artery revascularization. By comparing these two approaches, the study seeks to provide insights into improving myocardial perfusion and hemodynamic stability in this high-risk population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 19 and older who present with acute myocardial infarction complicated by cardiogenic shock and have multi-vessel coronary artery disease requiring VA-ECMO.
Not a fit: Patients who may not benefit from this study include those with single-vessel disease or other causes of shock unrelated to myocardial infarction.
Why it matters
Potential benefit: If successful, this study could lead to improved survival rates and better clinical outcomes for patients experiencing cardiogenic shock due to acute myocardial infarction.
How similar studies have performed: Previous studies, such as the CULPRIT-SHOCK trial, have shown mixed results regarding revascularization strategies in similar patient populations, indicating that this area remains an important focus for further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul
- Samsung Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Jeong Hoon Yang, MD — Samsung Medical Center
- Study coordinator: Jeong Hoon Yang, MD
- Email: jhysmc@gmail.com
- Phone: 82-2-3410-3419
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.