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

NCT05527717 | Recruiting Phase 4 DMC

• 1 other identifier: RESCUE-SHOCK
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

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).

Conditions

Cardiogenic Shock; Acute Myocardial Infarction; Multi Vessel Coronary Artery Disease; Extracorporeal Membrane Oxygenation

Outcome Measures

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)

  90 days after primary PCI

Secondary Outcomes (25)

• Rates of In-hospital mortality

  Up to 30 days

• Rates of In-hospital cardiac mortality

  Up to 30 days

• Rates of VA-ECMO weaning success

  Up to 30 days

• Time to VA-ECMO weaning

  Up to 30 days

• Rates of critical limb ischemia after successful VA-ECMO weaning

  Up to 30 days

Study Arms (2)

Culprit-lesion only PCI arm

ACTIVE COMPARATOR

Patients will receive culprit-lesion only PCI.

Procedure: Culprit lesion only PCI

Immediate multi-vesesl PCI arm

EXPERIMENTAL

Patients will receive immediate multi-vessel PCI.

Procedure: Immediate multi-vessel PCI

Interventions

Culprit lesion only PCI PROCEDURE

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.

Culprit-lesion only PCI arm

Immediate multi-vessel PCI PROCEDURE

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.

Immediate multi-vesesl PCI arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Jeong Hoon Yang, MD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeong Hoon Yang, MD

CONTACT

82-2-3410-3419; jhysmc@gmail.com

Ki Hong Choi, MD

CONTACT

82-2-3410-6653; cardiokh@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective, open-label, two-arm, randomized controlled trial

Study Record Dates

• First Submitted: August 27, 2022
• First Posted: September 2, 2022
• Study Start: November 16, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)