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.
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