EARLY REVASCULARIZATION FOR CARDIOGENIC SHOCK

这项为期5年的多中心随机试验将评估 早期血管重建术(ERV)采用批准的机械和手术方法 程序(主要是经皮冠状动脉腔内成形术和冠状动脉旁路移植术)，以降低目前的高- 心源性休克(CS)并发急性呼吸窘迫综合征住院死亡率 心肌梗塞(MI)。 在所有在急诊室或住院期间诊断的MI中，约有7.5% 导致CS和70%-80%的住院死亡率(通常在1-2天内 CS的诊断)。这一高死亡率在过去的几年里没有改变 二十年了。非随机临床系列和动物研究表明 CS并发急性心肌梗死后快速血运重建可能 大大提高了存活率。然而，报告的明显好处 非随机的临床研究可能(部分)是由于 选择偏向预后较好的患者。 这项试验的主要目标是评估ERV的有效性 (在CS诊断后16小时内和心肌梗塞后40小时内)减少 住院死亡率最低降低20%绝对降幅或更高 90%功率比较130例随机接受ERV的患者和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后数小时)。 次要目标包括：1.比较心肌梗死后6个月的存活率；2. 使用三种测量(A)评估幸存者的生活质量 为这类心梗后患者设计的主观生活质量评估 人口，一份身体机能调查问卷，来自纽约 可以构造功能类I-IV)。 所有临床怀疑为CS并发MI的患者 将成立一个登记处，收集有限的住院信息 手术、药物、住院时间和出院时的药瓶状况。这个 在试验中随机选择的符合条件的、同意的患者子集将拥有 更详细的住院信息摘要，并将遵循 至少在心肌梗塞后6个月，在2周后进行电话采访 出院，心肌梗塞后6个月和(如果早期招募)心肌梗死后12个月。 改良诺顿试验将在心肌梗死后6个月完成。决赛 如果患者的生命期满，电话访问将与代理人一起完成 在下一次预定的接触之前。 提出了一项提前停止规则，并进行了中期分析以进行监控 遵守协议。归根结底，还是要看意向 请客。建议在治疗组内进行一些亚组分析，以 确定最有可能或最不可能受益于ERV和 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.