Revascularization Strategy of Multivessel Disease for Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock Undergoing Veno-arterial Extracorporeal Membrane Oxygenator (RESCUE-SHOCK)

• ClinicalTrials.gov Identifier: NCT05527717
• Recruitment Status: Recruiting
• First Posted: September 2, 2022
• Last Update Posted: December 21, 2022
• Sponsor: Samsung Medical Center
• Information provided by (Responsible Party): Jeong Hoon Yang, Samsung Medical Center

Tracking Information

• First Submitted Date: August 27, 2022
• First Posted Date: September 2, 2022
• Last Update Posted Date: December 21, 2022
• Actual Study Start Date: November 16, 2022
• Estimated Primary Completion Date: December 31, 2027 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 31, 2022)

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)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 31, 2022)

• Rates of In-hospital mortality [ Time Frame: Up to 30 days ]
  Death by any cause in hospital
• Rates of In-hospital cardiac mortality [ Time Frame: Up to 30 days ]
  Death by cardiac cause in hospital
• 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.
• Time to VA-ECMO weaning [ Time Frame: Up to 30 days ]
  Time from VA-ECMO insertion to VA-ECMO weaning
• 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)
• Cerebral Performance Category (CPC) 3-5 at discharge [ Time Frame: Up to 30 days ]
  Neurologic performance scale at discharge
• Length of intensive-care unit (ICU) stay [ Time Frame: Up to 30 days ]
  ICU stay day
• Total procedural time [ Time Frame: Immediate after the index procedure ]
  Procedural time (minutes)
• Total amount of contrast use [ Time Frame: Immediate after the index procedure ]
  Contrast use (cc)
• Rates of all-cause mortality [ Time Frame: 90 Days and 12 months after primary PCI ]
  Death by any cause
• Rates of cardiac mortality [ Time Frame: 90 Days and 12 months after primary PCI ]
  Death by cardiac cause
• Requirement of cardiac replacement therapy [ Time Frame: 90 Days and 12 months after primary PCI ]
  LVAD insertion or heart transplantation
• Requirement of renal replacement therapy [ Time Frame: 90 Days and 12 months after primary PCI ]
  Continuous renal replacement therapy, hemodialysis, or peritoneal dialysis
• Rates of myocardial infarction (MI) [ Time Frame: 90 Days and 12 months after primary PCI ]
  spontaneous MI during follow-up
• 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
• 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
• Rates of stent thrombosis [ Time Frame: 90 Days and 12 months after primary PCI ]
  Academic Research Consortium (ARC)-defined definite or probable stent thrombosis
• 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
• 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
• Rates of target-lesion revascularization (TLR) [ Time Frame: 90 Days and 12 months after primary PCI ]
  TLR during follow-up
• Rates of target-vessel revascularization (TVR) [ Time Frame: 90 Days and 12 months after primary PCI ]
  TVR during follow-up
• Rates of repeat revascularization [ Time Frame: 90 Days and 12 months after primary PCI ]
  Repeat revascularization during follow-up
• Rates of cerebrovascular accident [ Time Frame: 90 Days and 12 months after primary PCI ]
  Cerebrovascular accident during follow-up
• Rates of bleeding [ Time Frame: 90 Days and 12 months after primary PCI ]
  Bleeding ARC [BARC] type 2, 3, or 5
• Rates of major bleeding [ Time Frame: 90 Days and 12 months after primary PCI ]
  (BARC type 3 or 5

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Revascularization Strategy of Multivessel Disease for Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock Undergoing Veno-arterial Extracorporeal Membrane Oxygenator
• Official 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)
• 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).

Detailed Description

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).

• Study Type: Interventional
• Study Phase: Phase 4

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Prospective, open-label, two-arm, randomized controlled trial

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

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

Intervention

• Procedure: Culprit lesion only PCI

  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.

• Procedure: Immediate multi-vessel PCI

  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.

Study Arms

• Active Comparator: Culprit-lesion only PCI arm
  Patients will receive culprit-lesion only PCI.
  Intervention: Procedure: Culprit lesion only PCI
• Experimental: Immediate multi-vesesl PCI arm
  Patients will receive immediate multi-vessel PCI.
  Intervention: Procedure: Immediate multi-vessel PCI

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 31, 2022): 560
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2028
• Estimated Primary Completion Date: December 31, 2027 (Final data collection date for primary outcome measure)

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 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 19 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Jeong Hoon Yang, MD; 82-2-3410-3419; jhysmc@gmail.com

Contact: Ki Hong Choi, MD; 82-2-3410-6653; cardiokh@gmail.com

• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT05527717
• Other Study ID Numbers: RESCUE-SHOCK
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Jeong Hoon Yang, Samsung Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Samsung Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jeong Hoon Yang, MD; Samsung Medical Center

• PRS Account: Samsung Medical Center
• Verification Date: December 2022