Conditions: Angina, Unstable Cardiovascular Diseases Heart Diseases Coronary Disease Myocardial Infarction Heart Failure, Congestive
Keywords: Acute Coronary Syndrome
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 911
Healthy volunteers: no

Brief summary:
The purpose of this study is to test the impact of pharmacological myocardial metabolic support, in the form of intravenous (IV) glucose, insulin and potassium (GIK), for the treatment of patients with threatened or established acute myocardial infarction (AMI).

Detailed description:
BACKGROUND:

Basic and clinical research suggests intravenous GIK metabolic myocardial support reduces ischemia-induced arrhythmias, progression from unstable angina pectoris (UAP) to acute myocardial infarction (AMI), myocardial infarction (MI) size, and mortality. Also, for ST elevation MI (STEMI), GIK may prolong time of benefit of coronary reperfusion. These effects should reduce short- and long-term mortality from ACS, including AMI and UAP, and the propensity for heart failure (HF). These benefits are related to the earliness of ACS, when both risk and opportunity to save lives are highest.

DESIGN NARRATIVE:

This is a randomized, placebo-controlled, double-blinded, multicenter clinical trial of IMMEDIATE GIK as early as possible in ACS in the prehospital emergency medical service (EMS) setting. Distinct from prior and ongoing GIK trials, this will test GIK for all ACS rather than only for AMI or STEMI in prehospital EMS. The primary hypothesis is that early GIK will prevent or reduce the size of acute myocardial infarction. Major secondary hypotheses posit GIK will reduce mortality (30 days and 1 year), reduce pre- or in-hospital cardiac arrest and the propensity for heart failure. Other hypotheses address mechanisms of these effects.

Arms:
arm 1: GIK = glucose-insulin-potassium; In one-liter: Dextrose 30% + 80 mEq Potassium Chloride + 50 units Regular Insulin; infused at 1.5 ml/kg/hour for a total of 12 hours. arm 2: Dextrose 5%, infused at 1.5 ml/kg/hour for total of 12 hours.

Interventions: intervention 1: GIK intervention 2: Placebo
Intervention descriptions: intervention 1: Intravenous solution, 1.5ml/kg/hour, continuous infusion for total of 12 hours. intervention 2: Intravenous solution of Dextrose 5 percent at 1.5 ml/kg/hour for a total of 12 hours.

Protocol document: