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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT00091507
First received: September 9, 2004
Last updated: June 5, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Angina, Unstable
Cardiovascular Diseases
Heart Diseases
Coronary Disease
Myocardial Infarction
Heart Failure, Congestive
Drug: GIK
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency Care Trial

Resource links provided by NLM:


Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:
  • Progression of Acute Coronary Syndrome to Myocardial Infarction [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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:
  • Cardiac Arrest [ Time Frame: 1 to 18 hours (From prehospital setting through hospitalization.) ] [ Designated as safety issue: No ]
    Outcome for all participants who had a cardiac arrest from initial contact in the prehospital setting through their subsequent hospitalization.

  • Heart Failure or Death [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Outcome for all participants (composite of re-hospitalization for heart failure or death within 30 days)

  • Mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Outcome for all participants (mortality at 30 days).

  • Cardiac Arrest or Acute Mortality [ Time Frame: Prehospital setting through hospitalization ] [ Designated as safety issue: No ]
    Outcome for all participants (composite of cardiac arrest or acute mortality)


Enrollment: 911
Study Start Date: November 2006
Study Completion Date: August 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%

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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00091507

Locations
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
Investigators
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
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00091507     History of Changes
Other Study ID Numbers: 165, U01HL077826, U01HL077823, U01HL077822, U01HL077821
Study First Received: September 9, 2004
Results First Received: November 13, 2012
Last Updated: June 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Tufts Medical Center:
Acute Coronary Syndrome

Additional relevant MeSH terms:
Angina, Unstable
Cardiovascular Diseases
Coronary Disease
Coronary Artery Disease
Heart Diseases
Heart Failure
Infarction
Myocardial Infarction
Angina Pectoris
Myocardial Ischemia
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases
Ischemia
Pathologic Processes
Necrosis
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014