KCT0007715尚未招募未知
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
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •(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 < 30mg/h.
- •d) serum lactate > 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 < 30mg/h.
- •d) serum lactate > 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*
排除标准
- •(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 <8 after the return of spontaneous circulation.
- •?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.
研究者
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