The RECREATE (REsearching Coronary REduction by Appropriately Targeting Euglycemia)
To evaluate the hypothesis that insulin will safely reduce glucose levels in patients with acute ST-elevation myocardial infarction and admission hyperglycemia and result in reduction in cardiovascular events. (The pilot is not powered to provide conclusive results on effects of insulin on clinical events; if safe and associated with glucose lowering a full scale trial is planned.
Randomized, open label, placebo control, parallel group design.
The primary outcome measure is the 24-hour difference in mean glucose between the two study groups. Secondary endpoints: the difference in mean glucose level achieved at 7 days or hospital discharge (whichever is first), the difference in mean glucose level achieved at 30 days between study groups, nonfatal recurrent myocardial infarction, nonfatal stroke, or cardiovascular death (as a composite and as separate outcomes), rehospitalization for congestive heart failure, all-cause mortality, resuscitated cardiac arrest or life-threatening arrhythmia (as a composite and as separate outcomes), cardiogenic shock, cardiac procedures, rehospitalization for any cause, symptomatic and severe hypoglycemic episodes, hypokalemic episodes. All clinical event endpoints are adjudicated.