Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency Care - IMMEDIATE

Mar 27, 2012
Font Size
A
A
A
Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
National Institutes of Health; National Heart, Lung, and Blood Institute
Date Presented:
01/01/2012
Date Published:
01/01/2012
Date Updated:
03/27/2012
Original Posted Date:
03/27/2012
References

Description:

The goal of the trial was to evaluate treatment with intravenous glucose, insulin, and potassium (GIK) compared with placebo when given early during a suspected acute coronary syndrome (ACS).

Hypothesis:

GIK will reduce progression to myocardial infarction (MI).

Study Design

  • Placebo Controlled
  • Blinded
  • Randomized
  • Parallel

Patient Populations:

  • Patients at least 30 years of age with ACS, as determined by paramedic judgment and one of the following: ACI-TIPI (Acute Cardiac Ischemia Time-Insensitive Predictive Instrument) probability of ACS >75%, thrombolytic predictive instrument for detection of ST-segment elevation MI (STEMI), or verification of STEMI by notification of receiving hospital catheterization laboratory

    Number of screened applicants: 54,579
    Number of enrollees: 911
    Duration of follow-up:
    Mean patient age: 64 years
    Percentage female: 28%
    Ejection fraction: 65%

Exclusions:

  • Heart failure
  • End-stage renal disease
  • Inability to provide informed consent
  • Pregnancy

Primary Endpoints:

  • Progression to MI, confirmed by enzymes and electrocardiogram

Secondary Endpoints:

  • Pre- or in-hospital mortality or cardiac arrest
  • Mortality at 30 days and 1 year
  • Mortality or hospitalization for heart failure at 30 days and 1 year

Drug/Procedures Used:

Patients with clinical signs consistent with an ACS were randomized to intravenous GIK (30% glucose, 50 units/liter insulin, 80 mEq KCL/liter at 1.5 cc/kg/h; n = 432) versus placebo at 5% glucose solution (n = 479). Study medication was continued for 12 hours.

There was an exception from informed consent requirements for emergency research. Written consent was obtained when the patient was stable at the receiving hospital.

Principal Findings:

Overall, 911 patients were randomized. The mean age was 64 years, 28% were women, mean systolic blood pressure was 143 mm Hg, and 29% had diabetes. Median time from symptom onset to study drug was 90 minutes. Primary percutaneous coronary intervention was performed in 48% of the patients.

The composite primary outcome, progression to MI, occurred in 49% of the GIK group versus 53% of the placebo group (p = 0.28).

30-day mortality: 4% versus 6% (p = 0.27), hospital mortality or cardiac arrest: 4% versus 9% (p = 0.01), 30-day mortality or hospitalization for heart failure: 6% versus 8% (p = 0.24), respectively. The benefit in reduction of hospital mortality or cardiac arrest appeared to be greatest when given within 1 hour of symptom onset.

30-day infarct size as % of left ventricular mass: 2 versus 10 (p = 0.01), left ventricular ejection fraction: 65% versus 60% (p = 0.13), respectively.

Serious adverse events: 7% versus 9% (p = 0.26), respectively. Among all participants, any K+ >5.5 mEq/L: 4% versus 2% (p = 0.098), among diabetics, any glucose >300 mg/dl: 44% versus 29% (p = 0.02), and among nondiabetics, any glucose >300 mg/dl: 11% versus 3% (p < 0.001), respectively.

Interpretation:

Among patients with suspected ACS, administration of intravenous GIK by paramedics did not reduce progression to MI. Some secondary endpoints such as infarct size and hospital mortality or cardiac arrest were lower in the GIK group. Hyperkalemia and hyperglycemia were more common in the GIK group. Administration of GIK by paramedics shortened the time from symptom onset to study drug; however, non-ACS diagnoses were likely enrolled, thus diminishing the opportunity to demonstrate benefit. Further evaluation of GIK in ACS is needed before widespread use can be advocated.

References:

Selker HP, Beshansky JR, Sheehan PR, et al. Out-of-Hospital Administration of Intravenous Glucose-Insulin-Potassium in Patients With Suspected Acute Coronary Syndromes: The IMMEDIATE Randomized Controlled Trial. JAMA 2012;Mar 27:[Epub ahead of print].

Presented by Dr. Harry Selker at ACC.12 & ACC-i2 with TCT, Chicago, IL, March 27, 2012.

Keywords: Myocardial Infarction, Acute Coronary Syndrome, Hyperglycemia, Insulin, Follow-Up Studies, Hospital Mortality, Blood Pressure, Hyperkalemia, Heart Arrest, Percutaneous Coronary Intervention, Glucose, Potassium, Cardioplegic Solutions, Heart Failure, Catheterization, Stroke Volume, Probability, Diabetes Mellitus


< Back to Listings