SHOCK TRIAL: LONG-TERM SURVIVAL AND STATISTICAL SUPPORT

SHOCK试验（心源性休克的早期血运重建：数据协调中心）的更新申请旨在支持SHOCK试验幸存者的长期随访和试验患者数据库的扩展分析。尽管其他研究小组失败了，但这项极具挑战性的试验的入组于1998年11月30日成功完成。 尽管两个治疗组的30天死亡率相似，但迄今为止的1年死亡率显示了紧急血运重建的显著受益（紧急血运重建的死亡率为54%，初始医疗稳定的死亡率为69%）。 这项在心源性休克（CS）患者中进行的紧急血运重建试验是唯一一项已完成的试验，因此提供了一个独特的随机队列以及一个无偏倚的登记数据库。 具体目标如下：1.试验患者随访：评估急性心肌梗死并发心源性休克存活者的长期生存率（心肌梗死后6 - 11年）和生活质量。 2.扩展试验数据分析：a）确定与心源性休克患者一年生存率相关的早期超声心动图参数，并评估这些参数与早期血运重建的相互作用; B）检查病程和患者结局的差异，作为年龄、性别、国家实践和系列血流动力学测量变化的函数，以及更好地表征心源性休克的相关病症和并发症。考虑到目前的资助最近结束，以及令人信服的一年生存数据显示紧急血运重建的长期受益，这一请求的时机是适当的。数据协调中心已建立了上述所有提案的基本系统，并成立了撰写小组，通过在当前SHOCK试验的框架内收集和分析这些新数据，将实现大量节省。

This application for a renewal of the SHOCK Trial (Early Revascularization for Cardiogenic Shock: Data Coordinating Center) is to support long-term follow-up of SHOCK Trial survivors and extended analyses of the Trial patient database. Enrollment in this very challenging trial was completed successfully November 30,1998 is spite of failures by other groups of investigators. Although 30-day mortality was similar for the two treatment arms, one-year mortality to date show a significant benefit of emergency revascularization (54 percent mortality with Emergency Revascularization vs. 69 percent with Initial Medical Stabilization). This trial of emergency revasculartization in cardiogenic shock (CS) patients is the only one completed and therefore provides a unique randomized cohort as well as an unbiased Registry database. Specific aims are as follows: 1. TRIAL PATIENT FOLLOW-UP: To estimate long-term survival rates (6 to 11 years post-MI) and the quality of life of survivors of acute MI complicated by cardiogenic shock. 2. EXTENDED TRIAL DATA ANALYSES: a) To determine the early echocardiographic parameters which are associated with one year survival in cardiogenic shock patients, and to assess the interaction of these parameters with early revascularization; b) To examine differences in disease course and patient outcome as a function of age, gender, national practice, and changes in serial hemodynamic measurements, as well as to better characterize the related conditions and complications of cardiogenic shock. The timing of this request is appropriate given the recent end of the current grant and the compelling one-year survival data revealing a long term benefit of emergency revascularization. The basic systems for all of the above proposals are in place at the Data Coordinating Center, writing groups have been formed, and substantial savings will be realized by collecting and analyzing these new data in the framework of the current SHOCK Trial.