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

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.

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