CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 911 enrolled
Drug / intervention
GIK +1 moredrug
Likely dose
GIK 1.5 ml/kg/hour continuous intravenous infusion for 12 hoursAI-extracted
Key inclusion· 3
  • ✓Symptoms of threatened or established acute myocardial infarction (AMI) such as chest pain/discomfort, arm/shoulder pain, jaw pain, epigastric discomfort, or shortness of breath
  • ✓12-lead ECG with ST elevation >1 mm, ST depression >0.5 mm, T wave inversion, hyperacute T waves, or left bundle branch block (not known to be old)
  • ✓ECG decision support confirmation: ACI-TIPI ≥75% and/or TPI detection of suspected STEMI
Key exclusion· 5
  • ✕End-stage kidney failure requiring dialysis
  • ✕Rales present more than halfway up the back (indicating pulmonary edema)
  • ✕Unable to comply with study requirements
  • ✕Incarcerated individuals

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00091507
NCT00091507Phase 3Completed
CompareCT.gov

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

Tufts Medical Center·interventional·Posted Sep 13, 2004·Updated Mar 2, 2016

In Brief

A Phase 3 clinical trial evaluating GIK and Placebo for Angina, Unstable and 5 related conditions. Completed, enrolled 911 participants across 13 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAngina, Unstable, Cardiovascular Diseases, Heart Diseases, Coronary Disease, Myocardial Infarction, Heart Failure, Congestive
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 13, 2004
Enrollment StartNov 1, 2006
Primary CompletionAug 1, 2011
Study CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 21.8 years ago

Interventions

GIKdrug

Intravenous solution, 1.5ml/kg/hour, continuous infusion for total of 12 hours.

Placebodrug

Intravenous solution of Dextrose 5 percent at 1.5 ml/kg/hour for a total of 12 hours.