Cardiovascular Diseases Clinical Trial
Official title:
Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency Care Trial
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).
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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