We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00091507
Recruitment Status : Completed
First Posted : September 13, 2004
Results First Posted : January 30, 2013
Last Update Posted : March 2, 2016
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Angina, Unstable Cardiovascular Diseases Heart Diseases Coronary Disease Myocardial Infarction Heart Failure, Congestive Drug: GIK Drug: Placebo Phase 3

Detailed Description:


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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 911 participants
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
Study Start Date : November 2006
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2012

Arm Intervention/treatment
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.
Drug: GIK
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.
Drug: Placebo
Intravenous solution of Dextrose 5 percent at 1.5 ml/kg/hour for a total of 12 hours.
Other Name: Dextrose 5%

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. Heart Failure or Death [ Time Frame: 30 days ]
    Outcome for all participants (composite of re-hospitalization for heart failure or death within 30 days)

  3. Mortality [ Time Frame: 30 days ]
    Outcome for all participants (mortality at 30 days).

  4. Cardiac Arrest or Acute Mortality [ Time Frame: Prehospital setting through hospitalization ]
    Outcome for all participants (composite of cardiac arrest or acute mortality)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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). 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00091507

Layout table for location information
United States, Alaska
Anchorage Site
Anchorage, Alaska, United States, 99501
United States, Connecticut
New Haven Site
New Haven, Connecticut, United States, 06511
United States, Georgia
Macon Site
Macon, Georgia, United States, 31208
United States, Massachusetts
Brockton Site
Brockton, Massachusetts, United States, 02301
Concord Site
Concord, Massachusetts, United States, 01742
United States, Minnesota
St. Paul Site
St. Paul, Minnesota, United States, 55128
United States, New Mexico
Albuquerque Site
Albuquerque, New Mexico, United States, 87131
United States, Pennsylvania
Hershey Site
Hershey, Pennsylvania, United States, 17033
United States, South Dakota
Sioux Falls Site
Sioux Falls, South Dakota, United States, 57104
United States, Texas
Dallas Site
Dallas, Texas, United States, 75201
El Paso Site
El Paso, Texas, United States, 79905
United States, Washington
Bellingham Site
Bellingham, Washington, United States, 98225
United States, Wisconsin
Milwaukee Site
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Tufts Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Layout table for investigator information
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
Publications of Results:
Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00091507    
Other Study ID Numbers: 165
U01HL077826 ( U.S. NIH Grant/Contract )
U01HL077823 ( U.S. NIH Grant/Contract )
U01HL077822 ( U.S. NIH Grant/Contract )
U01HL077821 ( U.S. NIH Grant/Contract )
First Posted: September 13, 2004    Key Record Dates
Results First Posted: January 30, 2013
Last Update Posted: March 2, 2016
Last Verified: February 2016
Keywords provided by Tufts Medical Center:
Acute Coronary Syndrome
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Cardiovascular Diseases
Myocardial Infarction
Heart Diseases
Coronary Disease
Angina, Unstable
Pathologic Processes
Myocardial Ischemia
Vascular Diseases
Angina Pectoris
Chest Pain
Neurologic Manifestations
Hypoglycemic Agents
Physiological Effects of Drugs