IMMEDIATE Trial - Out of Hospital Administration of Glucose, Insulin and Potassium.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency Care Trial

Conditions
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Angina, Unstable, Cardiovascular Diseases, Heart Diseases, Coronary Disease, Myocardial Infarction, Heart Failure, Congestive

Intervention / Treatment
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* Drug: GIK
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 -- GIK<br>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. | Drug: GIK<br>* Intravenous solution, 1.5ml/kg/hour, continuous infusion for total of 12 hours.<br>* Other names: Glucose-Insulin Potassium;|
| Placebo Comparator: 2 -- Placebo<br>Dextrose 5%, infused at 1.5 ml/kg/hour for total of 12 hours. | Drug: Placebo<br>* Intravenous solution of Dextrose 5 percent at 1.5 ml/kg/hour for a total of 12 hours.<br>* Other names: Dextrose 5%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of Acute Coronary Syndrome to Myocardial Infarction | Outcome for all participants during the first 24 hours of hospitalization; evidence of myocardial infarction is determined by ECG and biomarker results. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Arrest | Outcome for all participants who had a cardiac arrest from initial contact in the prehospital setting through their subsequent hospitalization. | 1 to 18 hours (From prehospital setting through hospitalization.) | 
| Heart Failure or Death | Outcome for all participants (composite of re-hospitalization for heart failure or death within 30 days) | 30 days | 
| Mortality | Outcome for all participants (mortality at 30 days). | 30 days | 
| Cardiac Arrest or Acute Mortality | Outcome for all participants (composite of cardiac arrest or acute mortality) | Prehospital setting through hospitalization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Coronary Syndrome