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

February 3, 2016 updated by: Tufts Medical Center

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

911

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99501
        • Anchorage Site
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • New Haven Site
    • Georgia
      • Macon, Georgia, United States, 31208
        • Macon Site
    • Massachusetts
      • Brockton, Massachusetts, United States, 02301
        • Brockton Site
      • Concord, Massachusetts, United States, 01742
        • Concord Site
    • Minnesota
      • St. Paul, Minnesota, United States, 55128
        • St. Paul Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Albuquerque Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Hershey Site
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Sioux Falls Site
    • Texas
      • Dallas, Texas, United States, 75201
        • Dallas Site
      • El Paso, Texas, United States, 79905
        • El Paso Site
    • Washington
      • Bellingham, Washington, United States, 98225
        • Bellingham Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Milwaukee Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Dextrose 5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 to 18 hours (From prehospital setting through hospitalization.)
Heart Failure or Death
Time Frame: 30 days
Outcome for all participants (composite of re-hospitalization for heart failure or death within 30 days)
30 days
Mortality
Time Frame: 30 days
Outcome for all participants (mortality at 30 days).
30 days
Cardiac Arrest or Acute Mortality
Time Frame: Prehospital setting through hospitalization
Outcome for all participants (composite of cardiac arrest or acute mortality)
Prehospital setting through hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tufts Medical Center

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

August 1, 2012

Study Registration Dates

First Submitted

September 9, 2004

First Submitted That Met QC Criteria

September 10, 2004

First Posted (ESTIMATE)

September 13, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

March 2, 2016

Last Update Submitted That Met QC Criteria

February 3, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 165
  • U01HL077826 (NIH)
  • U01HL077823 (NIH)
  • U01HL077822 (NIH)
  • U01HL077821 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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