Phase 3
N=911
IMMEDIATE Trial - Out of Hospital Administration of Glucose, Insulin and Potassium.
Angina, Unstable · Cardiovascular Diseases · Heart Diseases · Coronary Disease · Myocardial Infarction
Bottom Line
View on ClinicalTrials.gov: NCT00091507 ↗Enrolled (actual)
911
Serious AEs
7.9%
Results posted
Jan 2013
Primary outcome: Primary: Progression of Acute Coronary Syndrome to Myocardial Infarction — 200; 242 participants — p=0.28
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- GIK (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Tufts Medical Center
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression of Acute Coronary Syndrome to Myocardial Infarction |
200; 242 | 0.28 |
| SECONDARY Cardiac Arrest |
15; 29 | 0.08 |
| SECONDARY Heart Failure or Death |
23; 35 | 0.24 |
| SECONDARY Mortality |
18; 28 | 0.27 |
| SECONDARY Cardiac Arrest or Acute Mortality |
18; 40 | 0.01 sig |
Summary
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).
Eligibility Criteria
Inclusion Criteria
- Symptoms of threatened or established AMI including but not limited to:
- Chest pain, discomfort, or tightness
- Arm or shoulder pain
- Jaw pain
- Epigastric discomfort
- 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
Data sourced from ClinicalTrials.gov (NCT00091507). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.