This application is for the establishment of a Data Coordinating Center (DCC) at the Center for Cardiovascular Health Services Research at Tufts-New England Medical Center for the IMMEDIATE (Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency care) Trial, a national randomized controlled clinical trial of 15,450 subjects to test the impact of pharmacological myocardial metabolic support, in the form of intravenous glucose, insulin, and potassium (GIK) for patients with acute cardiac syndromes (ACS). The proposed IMMEDIATE Trial will address key questions raised by work to date: How much of the impressive protection conferred by GIK against ischemic cardiac damage in animal studies can be translated into clinical benefits for patients with ACS? Will the reduced mortality seen in inadequately powered and limited prior clinical trials of non-immediate GIK for acute myocardial infarction be confirmed in an adequately powered trial of early GIK for all types of ACS? The IMMEDIATE Trial DCC staff will be responsible for managing all trial data and for providing interim and final statistical analyses. The staff of the DCC will work with the study's Coordinating Center, Regional Coordinating Centers, and the Data Safety and Monitoring Board to ensure accurate and timely data collection and reporting. The DCC will provide design expertise in the development of the investigational plan and statistical analytic plan; maintain the entire study database from data entry through final study analysis; manage data security and integrity; adjudicate in a blinded fashion hospitalizations for heart failure; provide medical review to the clinical event adjudication process and timely safety reviews of reported adverse events; provide specialized reports to the trial's various study committees; and produce periodic DSMB safety analyses and reports and an interim efficacy analysis. The DCC will conduct all statistical analyses for the primary and secondary hypotheses and will produce a final report containing the results of the statistical analyses on the safety, efficacy and cost-effectiveness of the immediate use of GIK.
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