IMMEDIATE Trial - Out of Hospital Administration of Glucose, Insulin and Potassium. (IMMEDIATE)
|Angina, Unstable Cardiovascular Diseases Heart Diseases Coronary Disease Myocardial Infarction Heart Failure, Congestive||Drug: GIK Drug: Placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency Care Trial|
- Progression of Acute Coronary Syndrome to Myocardial Infarction [ Time Frame: 24 hours ]Outcome for all participants during the first 24 hours of hospitalization; evidence of myocardial infarction is determined by ECG and biomarker results.
- Cardiac Arrest [ Time Frame: 1 to 18 hours (From prehospital setting through hospitalization.) ]Outcome for all participants who had a cardiac arrest from initial contact in the prehospital setting through their subsequent hospitalization.
- Heart Failure or Death [ Time Frame: 30 days ]Outcome for all participants (composite of re-hospitalization for heart failure or death within 30 days)
- Mortality [ Time Frame: 30 days ]Outcome for all participants (mortality at 30 days).
- Cardiac Arrest or Acute Mortality [ Time Frame: Prehospital setting through hospitalization ]Outcome for all participants (composite of cardiac arrest or acute mortality)
|Study Start Date:||November 2006|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Experimental: 1 -- GIK
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.
Intravenous solution, 1.5ml/kg/hour, continuous infusion for total of 12 hours.
Other Name: Glucose-Insulin Potassium
Placebo Comparator: 2 -- Placebo
Dextrose 5%, infused at 1.5 ml/kg/hour for total of 12 hours.
Intravenous solution of Dextrose 5 percent at 1.5 ml/kg/hour for a total of 12 hours.
Other Name: Dextrose 5%
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00091507
|United States, Alaska|
|Anchorage, Alaska, United States, 99501|
|United States, Connecticut|
|New Haven Site|
|New Haven, Connecticut, United States, 06511|
|United States, Georgia|
|Macon, Georgia, United States, 31208|
|United States, Massachusetts|
|Brockton, Massachusetts, United States, 02301|
|Concord, Massachusetts, United States, 01742|
|United States, Minnesota|
|St. Paul Site|
|St. Paul, Minnesota, United States, 55128|
|United States, New Mexico|
|Albuquerque, New Mexico, United States, 87131|
|United States, Pennsylvania|
|Hershey, Pennsylvania, United States, 17033|
|United States, South Dakota|
|Sioux Falls Site|
|Sioux Falls, South Dakota, United States, 57104|
|United States, Texas|
|Dallas, Texas, United States, 75201|
|El Paso Site|
|El Paso, Texas, United States, 79905|
|United States, Washington|
|Bellingham, Washington, United States, 98225|
|United States, Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Study Chair:||Harry Selker, MD, MSPH||Tufts Medical Center, Trial Coordinating Center|
|Principal Investigator:||Ralph D'Agostino, PhD||Tufts Medical Center, Data Coordinating Center|
|Principal Investigator:||James Udelson, MD||Tufts Medical Center, LV Core Lab|