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NCT Number: NCT05527717

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

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).

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

Cardiogenic shock (CS) is a fatal complication of acute myocardial infarction (AMI). Until now, in this setting, it has been well-known that early revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) was associated with improved clinical outcomes although the rate of mortality remains still high in the mechanical circulatory support (MCS) era. In real-world practice, since clinically significant non-infarct related artery (non-IRA) stenosis or occlusion in addition to an IRA can be found in 70% to 80% of patients with AMI complicated by CS, the decision of revascularization strategy is a crucial issue to improve clinical outcomes in CS patients with multivessel disease. The 2013 American College of Cardiology (ACC)/American Heart Association (AHA) and the 2017 European Society of Cardiology (ESC) guidelines recommend considering PCI of severe stenosis in non-IRA during a primary procedure to improve overall myocardial perfusion and hemodynamic stability for patients with AMI and CS. However, the CULPRIT-SHOCK trial, which is the largest randomized trial in CS, demonstrated the 30-day risk of a composite of death or severe renal failure leading to renal-replacement therapy was higher in the immediate multi-vessel PCI than in the culprit lesion-only PCI group. In this regard, the recently updated guidelines do not recommend the routine non-IRA revascularization during primary PCI and it should be considered in selected cases in which there is a very severe flow-limiting non-IRA stenosis irrigating a large myocardial area. Nevertheless, there is still some unsolved issue regarding the role of non-IRA revascularization in AMI patients with CS. Majority of enrolled patients in the CULPRIT-SHOCK trial might have a mild form of CS (median systolic blood pressure of 100) and few patients received MCS devices (28.3% of study population). Furthermore, the mortality benefits of culprit-only PCI were attenuated at 1-year follow-up with an increased risk of repeat revascularization and hospitalization for heart failure. In contrast to the CULPRIT-SHOCK trial, the recent large United State registry from National Cardiovascular Data Registry demonstrated that the benefits of multi-vessel PCI in patients with non-ST-segment elevation MI and CS was more pronounced in those requiring MCS. In addition, recent data from the Korea Acute Myocardial Infarction National Health Registry showed that multivessel PCI was associated with a lower risk of all-cause death than culprit-only PCI, suggesting possible benefit of nonculprit lesion revascularization during the index hospitalization on long-term clinical outcomes.

Therefore, the current randomized trial sought 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 advanced form of CS patients who requiring veno-arterial extracorporeal membrane oxygenator (VA-ECMO).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 90 days after primary PCI

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

Secondary outcomes

  1. Rates of In-hospital mortality

    Time frame: Up to 30 days

    Death by any cause in hospital

  2. Rates of In-hospital cardiac mortality

    Time frame: Up to 30 days

    Death by cardiac cause in hospital

  3. Rates of VA-ECMO weaning success

    Time frame: Up to 30 days

    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.

  4. Time to VA-ECMO weaning

    Time frame: Up to 30 days

    Time from VA-ECMO insertion to VA-ECMO weaning

  5. Rates of critical limb ischemia after successful VA-ECMO weaning

    Time frame: Up to 30 days

    Critical limb ischemia is defined as limb pain that occurs at rest, or impending limb loss that is caused by severe compromise of blood flow to the affected extremity. (Rutherford classification 4, 5, or 6)

  6. Cerebral Performance Category (CPC) 3-5 at discharge

    Time frame: Up to 30 days

    Neurologic performance scale at discharge

  7. Length of intensive-care unit (ICU) stay

    Time frame: Up to 30 days

    ICU stay day

  8. Total procedural time

    Time frame: Immediate after the index procedure

    Procedural time (minutes)

  9. Total amount of contrast use

    Time frame: Immediate after the index procedure

    Contrast use (cc)

  10. Rates of all-cause mortality

    Time frame: 90 Days and 12 months after primary PCI

    Death by any cause

  11. Rates of cardiac mortality

    Time frame: 90 Days and 12 months after primary PCI

    Death by cardiac cause

  12. Requirement of cardiac replacement therapy

    Time frame: 90 Days and 12 months after primary PCI

    LVAD insertion or heart transplantation

  13. Requirement of renal replacement therapy

    Time frame: 90 Days and 12 months after primary PCI

    Continuous renal replacement therapy, hemodialysis, or peritoneal dialysis

  14. Rates of myocardial infarction (MI)

    Time frame: 90 Days and 12 months after primary PCI

    spontaneous MI during follow-up

  15. Rates of MI related to culprit vessel

    Time frame: 90 Days and 12 months after primary PCI

    MI related to culprit vessel during follow-up

  16. Rates of MI related to non-culprit vessel

    Time frame: 90 Days and 12 months after primary PCI

    MI related to non-culprit vessel during follow-up

  17. Rates of stent thrombosis

    Time frame: 90 Days and 12 months after primary PCI

    Academic Research Consortium (ARC)-defined definite or probable stent thrombosis

  18. Rates of Re-hospitalization due to heart failure

    Time frame: 90 Days and 12 months after primary PCI

    Re-hospitalization due to heart failure during follow-up

  19. Rates of Re-hospitalization due to any cause

    Time frame: 90 Days and 12 months after primary PCI

    Re-hospitalization due to any cause during follow-up

  20. Rates of target-lesion revascularization (TLR)

    Time frame: 90 Days and 12 months after primary PCI

    TLR during follow-up

  21. Rates of target-vessel revascularization (TVR)

    Time frame: 90 Days and 12 months after primary PCI

    TVR during follow-up

  22. Rates of repeat revascularization

    Time frame: 90 Days and 12 months after primary PCI

    Repeat revascularization during follow-up

  23. Rates of cerebrovascular accident

    Time frame: 90 Days and 12 months after primary PCI

    Cerebrovascular accident during follow-up

  24. Rates of bleeding

    Time frame: 90 Days and 12 months after primary PCI

    Bleeding ARC [BARC] type 2, 3, or 5

  25. Rates of major bleeding

    Time frame: 90 Days and 12 months after primary PCI

    (BARC type 3 or 5

Study contacts

Contact information is provided by the study sponsor or research team.

Jeong Hoon Yang, MD

CONTACT

[email protected]

82-2-3410-3419

Ki Hong Choi, MD

CONTACT

[email protected]

82-2-3410-6653

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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)

Acronym: RESCUE-SHOCK

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Sep 2, 2022
Registry last updated
Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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