None listed
Conditions
Interventions
Procedure/Surgery : 1. Study Procedure
(1)Revascularization for the IRA in both arms
Regardless of allocated arms, PCI for the culprit lesion should be performed using the standard techniques accordin
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Randomization 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. - Classic CS (Stage C) was defined as the following criteria. Systolic blood pressure less than 90 mmHg for more than 30 min or catecholamines required to maintain pressure more than 90 mmHg during systole with signs of organ failure (A or B) A. Sign of pulmonary congestion B. Sign of impaired organ perfusion with at least one of the following: a) altered mental status. b) cold, clammy skin and extremities. c) oliguria with urine output 2.0 mmol/l. - SCAI Shock classification D is defined as failure to respond to initial interventions with clinical deterioration of classic CS or SCAI Shock classification E is defined as cardiac arrest with ongoing cardiopulmonary resuscitation requiring VA-ECMO insertion. ?Target lesions amenable for planned primary PCI by operators’ decision ?Patients with multi-vessel disease* (2) Registry 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. - Classic CS (Stage C) was defined as the following criteria. Systolic blood pressure less than 90 mmHg for more than 30 min or catecholamines required to maintain pressure more than 90 mmHg during systole with signs of organ failure (A or B) A. Sign of pulmonary congestion B. Sign of impaired organ perfusion with at least one of the following: a) altered mental status. b) cold, clammy skin and extremities. c) oliguria with urine output 2.0 mmol/l. - SCAI Shock classification D is defined as failure to respond to initial interventions with clinical deterioration of classic CS or SCAI Shock classification E is defined as cardiac arrest with ongoing cardiopulmonary resuscitation requiring VA-ECMO insertion. ?Target lesions amenable for planned primary PCI by operators’ decision ?Patients with single-vessel disease*
Exclusion criteria
Exclusion criteria: (1)Common 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 24 hours. ?Known heparin intolerance. ?Other severe concomitant disease with limited life expectancy < 6 months ?Pregnancy or breast feeding ?Do not resuscitate wish.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| all-cause mortality or advanced heart failure requiring cardiac replacement therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| In-hospital mortality, In-hospital cardiac mortality, VA-ECMO weaning success, Time to VA-ECMO weaning, Critical limb ischemia after successful VA-ECMO weaning, CPC 3-5, Length of intensive-care unit stay, Total procedural time, Total amount of contrast use, Follow-up all-cause mortality, Follow-up cardiac mortality, Requirement of cardiac replacement therapy, Requirement of renal replacement therapy, Follow-up recurrent spontaneous MI, Follow-up MI related to culprit vessel Follow-up MI related to non-culprit vessel, Follow-up ARC-defined definite or probable stent thrombosis, Follow-up re-hospitalization due to heart failure, Follow-up re-hospitalization due to any cause, Follow-up target lesion revascularization, Follow-up target vessel revascularization, Follow-up repeat revascularization, Follow-up cerebrovascular accident, Follow-up bleeding (BARC type 2, 3, or 5), Follow-up major bleeding (BARC type 3, or 5) | — |
Countries
Korea, Republic of
Contacts
Public ContactJeongHoon Yang
Samsung Medical Center
Outcome results
None listed