To study the effects of early administration of glucose, insulin, and potassium (GIK) in reducing mortality in acute coronary syndromes.

BACKGROUND: Basic and clinical research suggest intravenous glucose, insulin, and potassium (GIK) metabolic myocardial support reduces ischemia-induced arrhythmias, progression from unstable angina pectoris I (UAP) to acute myocardial infarction (AMI), 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 acute coronary syndromes (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: IMMEDIATE is a randomized placebo-controlled clinical trial of immediate glucose, insulin, potassium (GIK) as early as possible in acute coronary syndrome (ACS): in the prehospital emergency medical service (EMS) setting, or, for those presenting to emergency departments (EDs), immediately upon ED arrival. Distinct from prior and ongoing GIK trials, this will test GIK for all ACS rather than only for AMI (or STEMI), and its use in prehospital EMS and ED settings. The primary hypothesis is that early GIK will reduce 30-day and 1-year mortality. Major secondary hypotheses posit GIK will reduce pre/in-hospital cardiac arrest, progression of unstable angina pectoris (UAP) to AMI, and by this and limiting MI size, will reduce the propensity for HF. Other hypotheses address mechanisms of these effects. The project will take 5 years: a year preparing and testing operations, 28 months enrolling patients, and then completion of data collection, analysis, and reporting. Clinical sites will be in Massachusetts, Texas, and Wisconsin.

Genders Eligible for Study:  Both

Criteria