Completed

IMMEDIATEImmediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency Care Trial

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What is being tested

GIK

+ Placebo

Drug
Who is being recruted

Angina Pectoris+13

+ Angina, Unstable

+ Cardiovascular Diseases

Over 30 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: November 2006
See protocol details

Summary

Principal SponsorTufts Medical Center
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2006

Actual date on which the first participant was enrolled.

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.

Official TitleImmediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency Care Trial 
NCT00091507
Principal SponsorTufts Medical Center
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

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

911 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 30 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Angina PectorisAngina, UnstableCardiovascular DiseasesChest PainCoronary DiseaseHeart DiseasesHeart FailureInfarctionIschemiaMyocardial InfarctionNecrosisNeurologic ManifestationsPainPathologic ProcessesVascular DiseasesMyocardial Ischemia

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
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.

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 13 locations

Suspended

Anchorage Site

Anchorage, United StatesSee the location
Suspended

New Haven Site

New Haven, United States
Suspended

Macon Site

Macon, United States
Suspended

Brockton Site

Brockton, United States
Completed13 Study Centers