NCT05527717 Revascularization Strategy of Multivessel Disease for Patients with Acute Myocardial Infarction Complicated by Cardiogenic Shock Undergoing Veno-arterial Extracorporeal Membrane Oxygenator
| NCT ID | NCT05527717 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Samsung Medical Center |
| Condition | Cardiogenic Shock |
| Study Type | INTERVENTIONAL |
| Enrollment | 560 participants |
| Start Date | 2022-11-16 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 560 participants in total. It began in 2022-11-16 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Jeong Hoon Yang, MD
PRINCIPAL INVESTIGATOR
Samsung Medical Center
Frequently Asked Questions
Who can join the NCT05527717 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Cardiogenic Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05527717 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05527717 currently recruiting?
Yes, NCT05527717 is actively recruiting participants. Contact the research team at jhysmc@gmail.com for enrollment information.
Where is the NCT05527717 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT05527717 clinical trial?
NCT05527717 is sponsored by Samsung Medical Center. The principal investigator is Jeong Hoon Yang, MD at Samsung Medical Center. The trial plans to enroll 560 participants.