Samsung Medical Center
Seoul, 06351, South Korea
Location status: Recruiting
NCT Number: NCT05527717
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).
Interested in participating?
Request Info19 year and older
All sexes
Interventional
Phase 4
Seoul, 06351, South Korea
Location status: Recruiting
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 90 days after primary PCI
all-cause mortality or requiring left ventricular assisted device (LVAD) insertion or heart transplantation)
Time frame: Up to 30 days
Death by any cause in hospital
Time frame: Up to 30 days
Death by cardiac cause in hospital
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 frame: Up to 30 days
Time from VA-ECMO insertion to 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)
Time frame: Up to 30 days
Neurologic performance scale at discharge
Time frame: Up to 30 days
ICU stay day
Time frame: Immediate after the index procedure
Procedural time (minutes)
Time frame: Immediate after the index procedure
Contrast use (cc)
Time frame: 90 Days and 12 months after primary PCI
Death by any cause
Time frame: 90 Days and 12 months after primary PCI
Death by cardiac cause
Time frame: 90 Days and 12 months after primary PCI
LVAD insertion or heart transplantation
Time frame: 90 Days and 12 months after primary PCI
Continuous renal replacement therapy, hemodialysis, or peritoneal dialysis
Time frame: 90 Days and 12 months after primary PCI
spontaneous MI during follow-up
Time frame: 90 Days and 12 months after primary PCI
MI related to culprit vessel during follow-up
Time frame: 90 Days and 12 months after primary PCI
MI related to non-culprit vessel during follow-up
Time frame: 90 Days and 12 months after primary PCI
Academic Research Consortium (ARC)-defined definite or probable stent thrombosis
Time frame: 90 Days and 12 months after primary PCI
Re-hospitalization due to heart failure during follow-up
Time frame: 90 Days and 12 months after primary PCI
Re-hospitalization due to any cause during follow-up
Time frame: 90 Days and 12 months after primary PCI
TLR during follow-up
Time frame: 90 Days and 12 months after primary PCI
TVR during follow-up
Time frame: 90 Days and 12 months after primary PCI
Repeat revascularization during follow-up
Time frame: 90 Days and 12 months after primary PCI
Cerebrovascular accident during follow-up
Time frame: 90 Days and 12 months after primary PCI
Bleeding ARC [BARC] type 2, 3, or 5
Time frame: 90 Days and 12 months after primary PCI
(BARC type 3 or 5
Contact information is provided by the study sponsor or research team.
Jeong Hoon Yang, MD
CONTACT
Ki Hong Choi, MD
CONTACT
Samsung Medical Center
Other
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
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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