Assessment of ECMO in Acute Myocardial Infarction With Non-reversible Cardiogenic Shock to Halt Organ Failure and Reduce Mortality (ANCHOR)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Treatment failure at Day 30
研究概览
简要总结
Data from case series and large retrospective trials suggest that the early treatment of cardiogenic shock AMI patients with the association of VA-ECMO and IABP may significantly decrease mortality, which is still unacceptably high nowadays (40-50% at 30 days).
An important benefit for the patients randomized to the ECMO arm is expected and the risk-to-benefit ratio is expected to be in favor of the experimental treatment arm.
详细描述
Scientific background
- Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is used more and more frequently in patients with acute myocardial infarction (AMI) and refractory cardiogenic shock despite the absence of high level scientific evidence to recommend the use of temporary circulatory support devices (TCS) in this setting.TCS support may also benefit to cardiogenic shock patients not initially refractory to conventional medical management since their mortality exceeds 40% and most of deaths are due to the development of refractory cardiogenic shock and multiple organ failure.
The ANCHOR trial is therefore designed to test the hypothesis that VA-ECMO support associated with IABP results in improved outcomes in comparison with optimal medical treatment alone in patients with AMI and cardiogenic shock. An ethical rescue option to VA-ECMO will however be provided to control patients with cardiogenic shock refractory to conventional medical treatment since recent data suggested survival up-to 50% with ECMO support in this setting.
Main objective - To determine if early VA-ECMO combined with IABP support and optimal medical treatment would improve the outcomes of patients with acute myocardial infarction complicated by cardiogenic shock as compared with optimal medical treatment alone.
Scope of the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cardiogenic shock complicating acute myocardial infarction (STEMI or NSTEMI)
- •Revascularization by PCI for acute myocardial infarction has been performed or is planned in the following 60 minutes
- •Systolic blood pressure <90 mmHg for >30 min or catecholamine support required to maintain systolic blood pressure >90 mmHg
- •Signs of pulmonary congestion
- •Signs of impaired organ perfusion with at least one of the following:
- •Altered mental status OR cold, clammy skin and extremities OR oliguria with urine output <30 ml/h OR serum lactate >2.0 mmol/l
排除标准
- •Age <18 years
- •Pregnancy
- •Onset of shock >24 Hours
- •Shock of other cause (hypovolemic, anaphylactic or vagal shock)
- •Shock due to massive pulmonary embolism
- •Resuscitation >30 minutes
- •No intrinsic heart activity
- •Patient moribund on the day of randomization or SAPS II >90
- •Surgical revascularization for AMI (CABG) planned or already performed prior to randomization
- •Cerebral deficit with fixed dilated pupils or Irreversible neurological pathology
- •Mechanical infarction complication (massive mitral regurgitation, pericardium drainage required, septal ventricular defect)
- •Severe peripheral artery disease or previous aortic or ilio-femoral surgery precluding ECMO and IABP insertion
- •Aortic regurgitation > II
- •Other severe concomitant disease with limited life expectancy < 1 year
- •Proven heparin-induced thrombocytopenia
- •ECMO device not immediately available
结局指标
主要结局
Treatment failure at Day 30
时间窗: At day 30
Death in the ECMO group and death OR rescue ECMO in the control group
次要结局
- Major Adverse Cardiovascular Events(At day 30)
- Need for repeat revascularization with PCI and/or CABG(At day 30)
- Cardiac transplantation(At day 30)
- Stroke at one year(At one year)
- Renal replacement therapy at one year(At one year)
- Re-hospitalization for heart failure(At one year)
- Red blood cells transfused(At day 30)
- Stroke(At day 30)
- Recurrent myocardial infarction(At day 30)
- Need for renal replacement therapy(At day 30)
- Durations of ICU stay and hospitalization(At day 30)
- Recurrent myocardial infarction at one year(At one year)
- PCI and/or CABG at one year(At one year)
- NYHA/INTERMACS status at one year(At one year)
- Mortality at Day 30(At day 30)
- Serum lactate(At day 30)
- LV function(At day 30)
- NYHA/INTERMACS status(At day 30)
- ECMO-related complications(At day 30)
- Mortality at one year(At one year)
- Major Adverse Cardiovascular at one year(At one year)
- Escalation to LVAD or total artificial heart(At day 30)
- Major bleeding(At day 30)
- Number of days alive without organ failure at day 30(At day 30)
- Treatment failure at one year(At one year)
- LVAD at one year(At one year)
- Cardiac transplant at one year(At one year)
- Major bleeding at one year(At one year)
- Returned to work at one year(At one year)
- LV ejection fraction at one year(At one year)
- Short Form 36 (SF-36) questionnaire at one year(At one year)