NCT05527717RecruitingPhase 4
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)
Source: ClinicalTrials.gov · Last updated 6 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 560 (estimated)
- First submitted
- 27 Aug 2022
- Start date
- 16 Nov 2022
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Samsung Medical Center
- Diseases
- Coronary artery disease
- NCT number
- NCT05527717
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 560
- From 16 Nov 2022 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Other severe concomitant disease with limited life expectancy \< 6 months
Other illness
- 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)
Other
- 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).
- Onset of shock \>24 hours.
- Known heparin intolerance.
- Pregnancy or breast feeding
- Do not resuscitate wish
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.