Status:
COMPLETED
IMMEDIATE Trial - Out of Hospital Administration of Glucose, Insulin and Potassium.
Lead Sponsor:
Tufts Medical Center
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Angina, Unstable
Cardiovascular Diseases
Eligibility:
All Genders
30+ years
Phase:
PHASE3
Brief 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 wit...
Detailed Description
BACKGROUND: Basic and clinical research suggests intravenous GIK metabolic myocardial support reduces ischemia-induced arrhythmias, progression from unstable angina pectoris (UAP) to acute myocardial...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
911 Patients enrolled
Trial Details
Trial ID
NCT00091507
Start Date
November 1 2006
End Date
August 1 2012
Last Update
March 2 2016
Active Locations (13)
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1
Anchorage Site
Anchorage, Alaska, United States, 99501
2
New Haven Site
New Haven, Connecticut, United States, 06511
3
Macon Site
Macon, Georgia, United States, 31208
4
Brockton Site
Brockton, Massachusetts, United States, 02301