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

ConditionsCardiogenic ShockAcute Myocardial InfarctionMulti Vessel Coronary Artery DiseaseExtracorporeal Membrane Oxygenation
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorSamsung Medical Center

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Culprit lesion only PCI

    Procedure/Surgery

    Randomization will be done after coronary angiography before or during primary PCI for IRA. Patients will be randomized to either immediate multi-vesesl PCI group or culprit-lesion only PCI group with 1:1 ratio. This group will be taken culprit-lesion only PCI during primary PCI.

  • Immediate multi-vessel PCI

    Procedure/Surgery

    Randomization will be done after coronary angiography before or during primary PCI for IRA. Patients will be randomized to either immediate multi-vesesl PCI group or culprit-lesion only PCI group with 1:1 ratio. This group will be taken immediate multi-vesesl PCI during primary PCI.

Treatment groups

560 Participants
are divided into 2 treatment groups
Group A: Culprit-lesion only PCI armActive comparator 1 intervention
Group B: Immediate multi-vesesl PCI armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Rates of all-cause mortality or advanced heart failure requiring cardiac replacement therapy

all-cause mortality or requiring left ventricular assisted device (LVAD) insertion or heart transplantation)

Time frame
90 days after primary PCI

Secondary outcomes

1

Rates of In-hospital mortality

Death by any cause in hospital

Time frame
Up to 30 days
2

Rates of In-hospital cardiac mortality

Death by cardiac cause in hospital

Time frame
Up to 30 days
3

Rates of VA-ECMO weaning success

Successful weaning of VA-ECMO was defined as successful removal of VA-ECMO and not requiring further mechanical support because of recurring cardiogenic shock over the following 48 hours.

Time frame
Up to 30 days
4

Time to VA-ECMO weaning

Time from VA-ECMO insertion to VA-ECMO weaning

Time frame
Up to 30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Samsung Medical Center

Lead sponsor

Source ClinicalTrials.gov
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