EARLY REVASCULARIZATION FOR CARDIOGENIC SHOCK

这项为期5年的多中心随机试验将评估 使用获批的机械和手术进行早期血运重建（ERV） 手术（主要是PTCA和CABG），以降低目前的高- 心源性休克（CS）并发急性 心肌梗死（MI）。 约7.5%的MI在急诊室或住院期间诊断 导致CS和70%-80%住院死亡率（通常在1-2天内 CS的诊断）。 这一高死亡率在过去几年中没有改变。 二十年 非随机临床系列和动物研究表明， 冠状窦并发急性心肌梗死后的快速血运重建可能 大大提高了生存率。 然而， 非随机临床研究可能（部分）源于 选择偏向于预后较好的患者。 本试验的主要目的是评估ERV的有效性 （CS诊断后16小时内和MI后40小时内） 住院死亡率绝对降低至少20%或更多， 90%把握度比较随机分配至ERV组的130例患者和130例患者 随机接受常规治疗（CT），包括溶栓剂和 可能的晚期血运重建尝试（大于或等于88 MI后小时）。 次要目标包括：1。比较MI后6个月的存活率;和2. 使用三项措施评估幸存者的生活质量（a 为此类MI后患者设计的主观生活质量评估 人群，身体功能问卷，其中NYHA 可以构造功能类I-IV）。 临床疑似诊断为CS并发MI的所有患者 将形成一个登记处，收集有限的信息，在医院 程序、药物、住院时间和出院时的药瓶状态。 的 在试验中随机分配的合格、知情同意的患者子集将 更详细的住院信息摘要，并将随访 MI后至少6个月，并在2周后进行电话访谈 出院、MI后6个月和（如果提前招募）MI后12个月。 修改后的Naughton测试将在MI后6个月完成。 最终 如果患者死亡，将由代理人完成电话访谈 在下一次预定的接触之前。 提出了一个早期停止规则，并进行中期分析以监测 方案依从性。 最后的分析将根据意图， 请客 建议在治疗组内进行一些亚组分析， 确定最有可能或最不可能从ERV中获益的重要亚组， 其他治疗组合。

This 5-year multi-center randomized trial will assess the effectiveness of Early Revascularization (ERV) using approved mechanical and surgical procedures (primarily PTCA and CABG) in reducing the current high in- hospital mortality rate from cardiogenic shock (CS) complicating acute myocardial infarction (MI). Approximately 7.5% of all MI's which are diagnosed in an ER or in-hospital lead to CS and in-hospital death rate of 70%-80% (usually within 1-2 days of diagnosis of CS). This high death rate has not changed in the last two decades. Non-random clinical series and animal studies suggest that rapid revascularization following CS complicating acute MI may substantially improve survival. However the apparent benefit reported in the non-random clinic studies could have resulted (partly) from a selection bias towards patients with a better prognosis. The primary goal of this trial is to assess the effectiveness of ERV (within 16 hours of CS diagnosis and within 40 hours post MI) in reducing in-hospital mortality by a minimum of 20% absolute reduction or more with 90% power comparing 130 patients randomized to ERV with 130 patients randomized to conventional therapy (CT) consisting of thrombolytics and a possible late attempt at revascularization (greater than or equal to 88 hours post MI). Secondary aims include: 1. comparing survival at 6 months post-MI; and 2. assessing the quality of life among survivors using three measures (a subjective Quality of Life assessment designed for this type of post-MI population, a physical functioning questionnaire from which NYHA functional classes I-IV can be constructed). All patients with a clinically suspected diagnosis of CS complicating MI will form a Registry, with limited information collected on in-hospital procedures, medications, length of stay and vial status at discharge. The subset of eligible, consenting patients randomized in the trial will have more detailed in-hospital information abstracted and will be followed for at least six months post MI with telephone interviews at 2 weeks post discharge, 6 months post-MI and (if recruited early) 12 months post-MI. The modified Naughton test will be completed at 6 months post-MI. A final telephone interview will be completed with a proxy if the patient expires before the next scheduled contact. An early stopping rule is proposed with interim analyses to monitor protocol adherence. The final analysis will be according to intention to treat. Some subgroup analyses within treatment groups are proposed to identify important subgroups most or least likely to benefit from ERV and other therapeutic combinations.