The original IMMEDIATE Trial, supported by the National Heart Lung and Blood Institute (NHLBI), was the first double-blind placebo controlled study of
Glucose-Insulin-Potassium (GIK) for Acute coronary syndromes (ACS), and the first to assess impact of very early administration of GIK, as administered by
paramedics in the pre-hospital setting.
The IMMEDIATE Trial tested the hypothesis that GIK will provide metabolic support to the ischemic myocardium, thus optimizing the likelihood and extent of
myocardial salvage, reducing the early risk of sudden death, and improving clinical outcomes.
Key Information about the original IMMEDIATE Trial.
Subjects enrolled: 871
Sites: Enrollment occurred across 36 EMS agencies in 13 US cities
Primary Endpoint: Progression of ACS to myocardial infarction within 24 hours.
Secondary Endpoint: Survival at 30 days and a composite of pre-hospital or in-hospital cardiac arrest or in-hospital mortality
Results: Although GIK did not significantly reduce the primary endpoint (progression to AMI), it did significantly reduce the composite endpoint of cardiac
arrest or mortality - by 50% for those presenting with suspected ACS, and by 60% for those presenting with ST elevation AMI (STEMI). GIK also reduced infarct
size by 80%. JAMA Article PMID: 22452807
The IMMEDIATE Trial differed to previous clinical trials for GIK in two main aspects:
1) The IMMEDIATE Trial was specifically designed to deliver GIK as early as possible. The infusion of GIK was started immediately upon the patient's
presentation to the medical system, in the EMS setting, by ambulance paramedics. Previous GIK trials did not administer GIK hours after the onset of
symptoms, after AMI was diagnosed in the hospital. The median time to treatment from symptom onset in the IMMEDIATE Trial was 90 minutes, compared with
six or more hours in most previous trials. Although previous laboratory studies have shown that early GIK treatment is critical for any physiological
benefit, the IMMEDIATE Trial is the only clinical study to focus on this important aspect.
2) All patients with suspected ACS were eligible for the IMMEDIATE trial, rather than only patients with AMI or STEMI as was the case in previous GIK
clinical trials. Participating sites were from a variety of rural, urban, large academic medical centers, and community hospitals reflecting diverse
study populations and settings. This differs from a standard efficacy trial that examines the effect of a treatment in optimally selected patients,
under advantageous conditions, for short periods, for the purposes of regulatory approval and marketing.
The results of the IMMEDIATE Trial were very encouraging. However, because other prior GIK studies had not been positive - even though they gave GIK later than
would be expected to work, and had not been double-blind placebo studies such as the IMMEDIATE Trial - FDA has requested a confirmatory trial, which is why we
are mounting the IMMEDIATE-2 Trial.
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