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

Tufts University

Status and phase: Completed; Phase 3

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

Treatments: Drug: GIK; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00091507

U01HL077821 (U.S. NIH Grant/Contract)

U01HL077823 (U.S. NIH Grant/Contract)

U01HL077822 (U.S. NIH Grant/Contract)

165

U01HL077826 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 911 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Symptoms of threatened or established AMI including but not limited to:

  1. Chest pain, discomfort, or tightness
  2. Arm or shoulder pain
  3. Jaw pain
  4. Epigastric discomfort
  5. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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911 participants in 2 patient groups, including a placebo group

1 -- GIK

Experimental group

Description:

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.

Treatment:

Drug: GIK

2 -- Placebo

Placebo Comparator group

Description:

Dextrose 5%, infused at 1.5 ml/kg/hour for total of 12 hours.

Treatment:

Drug: Placebo