Acute Myocardial Infarction Clinical Trial
— RESCUE-SHOCKOfficial 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)
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).
Status | Recruiting |
Enrollment | 560 |
Est. completion date | December 31, 2028 |
Est. primary completion date | December 31, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Samsung Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Samsung Medical Center |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Rates of In-hospital mortality | Death by any cause in hospital | Up to 30 days | |
Secondary | Rates of In-hospital cardiac mortality | Death by cardiac cause in hospital | Up to 30 days | |
Secondary | 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. | Up to 30 days | |
Secondary | Time to VA-ECMO weaning | Time from VA-ECMO insertion to VA-ECMO weaning | Up to 30 days | |
Secondary | Rates of critical limb ischemia after successful VA-ECMO weaning | 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) | Up to 30 days | |
Secondary | Cerebral Performance Category (CPC) 3-5 at discharge | Neurologic performance scale at discharge | Up to 30 days | |
Secondary | Length of intensive-care unit (ICU) stay | ICU stay day | Up to 30 days | |
Secondary | Total procedural time | Procedural time (minutes) | Immediate after the index procedure | |
Secondary | Total amount of contrast use | Contrast use (cc) | Immediate after the index procedure | |
Secondary | Rates of all-cause mortality | Death by any cause | 90 Days and 12 months after primary PCI | |
Secondary | Rates of cardiac mortality | Death by cardiac cause | 90 Days and 12 months after primary PCI | |
Secondary | Requirement of cardiac replacement therapy | LVAD insertion or heart transplantation | 90 Days and 12 months after primary PCI | |
Secondary | Requirement of renal replacement therapy | Continuous renal replacement therapy, hemodialysis, or peritoneal dialysis | 90 Days and 12 months after primary PCI | |
Secondary | Rates of myocardial infarction (MI) | spontaneous MI during follow-up | 90 Days and 12 months after primary PCI | |
Secondary | Rates of MI related to culprit vessel | MI related to culprit vessel during follow-up | 90 Days and 12 months after primary PCI | |
Secondary | Rates of MI related to non-culprit vessel | MI related to non-culprit vessel during follow-up | 90 Days and 12 months after primary PCI | |
Secondary | Rates of stent thrombosis | Academic Research Consortium (ARC)-defined definite or probable stent thrombosis | 90 Days and 12 months after primary PCI | |
Secondary | Rates of Re-hospitalization due to heart failure | Re-hospitalization due to heart failure during follow-up | 90 Days and 12 months after primary PCI | |
Secondary | Rates of Re-hospitalization due to any cause | Re-hospitalization due to any cause during follow-up | 90 Days and 12 months after primary PCI | |
Secondary | Rates of target-lesion revascularization (TLR) | TLR during follow-up | 90 Days and 12 months after primary PCI | |
Secondary | Rates of target-vessel revascularization (TVR) | TVR during follow-up | 90 Days and 12 months after primary PCI | |
Secondary | Rates of repeat revascularization | Repeat revascularization during follow-up | 90 Days and 12 months after primary PCI | |
Secondary | Rates of cerebrovascular accident | Cerebrovascular accident during follow-up | 90 Days and 12 months after primary PCI | |
Secondary | Rates of bleeding | Bleeding ARC [BARC] type 2, 3, or 5 | 90 Days and 12 months after primary PCI | |
Secondary | Rates of major bleeding | (BARC type 3 or 5 | 90 Days and 12 months after primary PCI |
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