Official Title: “IMMEDIATE Trial: 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).

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: April 2011

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.

Intervention(s) in this Clinical Trial

• Drug: Glucose, Insulin and Potassium
  • Intravenous solution, 1.5ml/kg/hour, continuous infusion for total of 12 hours.
• Drug: Dextrose 5%
  • Intravenous solution of Dextrose 5 percent at 1.5 ml/kg/hour for a total of 12 hours.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

Primary Measures

• Acute myocardial infarction
  • Time Frame: 24 hours
    Safety Issue?: No

Secondary Measures

• Cardiac arrest
  • Time Frame: Prehospital and in-hospital
    Safety Issue?: No
• Heart failure or death
  • Time Frame: 30 days and 1 year
    Safety Issue?: No
• Mortality
  • Time Frame: 30 days and 1 year
    Safety Issue?: No

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)

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Overall Clinical Trial Officials and Contacts

Harry Selker, MD, MSPH Study Chair Tufts Medical Center, Trial Coordinating Center  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00091507

Study ID Number: 165

ClinicalTrials.gov Identifier: NCT00091507

Health Authority: United States: Food and Drug Administration

Click here for the the IMMEDIATE Trial web site