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.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01HL077826-02
Application #
6946301
Study Section
Clinical Trials Review Committee (CLTR)
Program Officer
Desvigne-Nickens, Patrice
Project Start
2004-09-01
Project End
2009-08-31
Budget Start
2005-09-01
Budget End
2006-08-31
Support Year
2
Fiscal Year
2005
Total Cost
$1,251,007
Indirect Cost
Name
Tufts University
Department
Type
DUNS #
079532263
City
Boston
State
MA
Country
United States
Zip Code
02111
Ellis, K L; Zhou, Y; Rodriguez-Murillo, L et al. (2017) Common variants associated with changes in levels of circulating free fatty acids after administration of glucose-insulin-potassium (GIK) therapy in the IMMEDIATE trial. Pharmacogenomics J 17:76-83
Mukherjee, Jayanta T; Beshansky, Joni R; Ruthazer, Robin et al. (2016) In-hospital measurement of left ventricular ejection fraction and one-year outcomes in acute coronary syndromes: results from the IMMEDIATE Trial. Cardiovasc Ultrasound 14:29
Selker, Harry P; Harris, William S; Rackley, Charles E et al. (2016) Very early administration of glucose-insulin-potassium by emergency medical service for acute coronary syndromes: Biological mechanisms for benefit in the IMMEDIATE Trial. Am Heart J 178:168-75
Alkofide, Hadeel; Huggins, Gordon S; Beshansky, Joni R et al. (2015) C-Reactive protein reactions to glucose-insulin-potassium infusion and relations to infarct size in patients with acute coronary syndromes. BMC Cardiovasc Disord 15:163
Ellis, K L; Zhou, Y; Beshansky, J R et al. (2015) Genetic modifiers of response to glucose-insulin-potassium (GIK) infusion in acute coronary syndromes and associations with clinical outcomes in the IMMEDIATE trial. Pharmacogenomics J 15:488-95
Ellis, K L; Zhou, Y; Beshansky, J R et al. (2015) Genetic variation at glucose and insulin trait loci and response to glucose-insulin-potassium (GIK) therapy: the IMMEDIATE trial. Pharmacogenomics J 15:55-62
Ray, Madhab; Ruthazer, Robin; Beshansky, Joni R et al. (2015) A predictive model to identify patients with suspected acute coronary syndromes at high risk of cardiac arrest or in-hospital mortality: An IMMEDIATE Trial sub-study,,. Int J Cardiol Heart Vasc 9:37-42
Alkofide, Hadeel; Huggins, Gordon S; Ruthazer, Robin et al. (2015) Serum adiponectin levels in patients with acute coronary syndromes: Serial changes and relation to infarct size. Diab Vasc Dis Res 12:411-9
Sullivan, Alison L; Beshansky, Joni R; Ruthazer, Robin et al. (2014) Factors associated with longer time to treatment for patients with suspected acute coronary syndromes: a cohort study. Circ Cardiovasc Qual Outcomes 7:86-94
Selker, Harry P; Udelson, James E; Massaro, Joseph M et al. (2014) One-year outcomes of out-of-hospital administration of intravenous glucose, insulin, and potassium (GIK) in patients with suspected acute coronary syndromes (from the IMMEDIATE [Immediate Myocardial Metabolic Enhancement During Initial Assessment and Trea Am J Cardiol 113:1599-605

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