Revascularization Strategy of Multivessel Disease for Patients with Acute Myocardial Infarction Complicated by Cardiogenic Shock Undergoing Veno-arterial Extracorporeal Membrane Oxygenator
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
19 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
560 (estimated)
Sponsor
Samsung Medical Center · Other
Who this trial is looking for
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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).
Trial Locations
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Status
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…
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
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