IMMEDIATE Trial - Out of Hospital Administration of Glucose, Insulin and Potassium.
- Conditions
- Angina, UnstableCardiovascular DiseasesHeart DiseasesCoronary DiseaseMyocardial InfarctionHeart Failure, Congestive
- Interventions
- Drug: GIKDrug: Placebo
- Registration Number
- NCT00091507
- Lead Sponsor
- Tufts Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 911
-
Symptoms of threatened or established AMI including but not limited to:
- Chest pain, discomfort, or tightness
- Arm or shoulder pain
- Jaw pain
- Epigastric discomfort
- Shortness of breath
-
12-lead electrocardiogram (ECG) with two or more contiguous leads with ST elevation greater than 1 mm, ST depression greater than 0.5 mm, T wave inversion or other T wave abnormalities (hyperacute T waves), or left bundle branch block (not known to be old). Identification aided by the acute cardiac ischemia time-insensitive predictive instrument (ACI-TIPI)and thrombolytic predictive instrument (TPI) decision support software (ACI-TIPI >= 75% and TPI detection of suspected STEMI).
- End-stage kidney failure requiring dialysis
- Rales present more than halfway up the back
- Unable to comply with the requirements of the study
- Incarcerated
- Known to be pregnant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 -- GIK 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. 2 -- Placebo Placebo Dextrose 5%, infused at 1.5 ml/kg/hour for total of 12 hours.
- Primary Outcome Measures
Name Time Method Progression of Acute Coronary Syndrome to Myocardial Infarction 24 hours Outcome for all participants during the first 24 hours of hospitalization; evidence of myocardial infarction is determined by ECG and biomarker results.
- Secondary Outcome Measures
Name Time Method Cardiac Arrest 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 30 days Outcome for all participants (composite of re-hospitalization for heart failure or death within 30 days)
Mortality 30 days Outcome for all participants (mortality at 30 days).
Cardiac Arrest or Acute Mortality Prehospital setting through hospitalization Outcome for all participants (composite of cardiac arrest or acute mortality)
Trial Locations
- Locations (13)
Brockton Site
🇺🇸Brockton, Massachusetts, United States
Dallas Site
🇺🇸Dallas, Texas, United States
New Haven Site
🇺🇸New Haven, Connecticut, United States
Concord Site
🇺🇸Concord, Massachusetts, United States
El Paso Site
🇺🇸El Paso, Texas, United States
Milwaukee Site
🇺🇸Milwaukee, Wisconsin, United States
Macon Site
🇺🇸Macon, Georgia, United States
Anchorage Site
🇺🇸Anchorage, Alaska, United States
St. Paul Site
🇺🇸St. Paul, Minnesota, United States
Albuquerque Site
🇺🇸Albuquerque, New Mexico, United States
Hershey Site
🇺🇸Hershey, Pennsylvania, United States
Sioux Falls Site
🇺🇸Sioux Falls, South Dakota, United States
Bellingham Site
🇺🇸Bellingham, Washington, United States