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| Sponsors and Collaborators: |
National Heart, Lung, and Blood Institute (NHLBI) Tufts Medical Center |
|---|---|
| Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
| ClinicalTrials.gov Identifier: | NCT00091507 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Angina, Unstable Cardiovascular Diseases Heart Diseases Coronary Disease Myocardial Infarction Heart Failure, Congestive |
Drug: Glucose, Insulin and Potassium Drug: Dextrose 5% |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | IMMEDIATE Trial: Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency Care Trial |
| Estimated Enrollment: | 880 |
| Study Start Date: | November 2006 |
| Estimated Study Completion Date: | April 2011 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: Glucose, Insulin and Potassium
Intravenous solution, 1.5ml/kg/hour, continuous infusion for total of 12 hours.
|
| 2: Placebo Comparator |
Drug: Dextrose 5%
Intravenous solution of Dextrose 5 percent at 1.5 ml/kg/hour for a total of 12 hours.
|
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.
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Symptoms of threatened or established AMI including but not limited to:
Exclusion Criteria:
Contacts and Locations| United States, Alaska | |
| Anchorage Site | |
| Anchorage, Alaska, United States, 99501 | |
| United States, Connecticut | |
| New Haven Site | |
| New Haven, Connecticut, United States, 06511 | |
| United States, Georgia | |
| Macon Site | |
| Macon, Georgia, United States, 31208 | |
| United States, Massachusetts | |
| Concord Site | |
| Concord, Massachusetts, United States, 01742 | |
| Brockton Site | |
| Brockton, Massachusetts, United States, 02301 | |
| United States, New Mexico | |
| Albuquerque Site | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, South Dakota | |
| Sioux Falls Site | |
| Sioux Falls, South Dakota, United States, 57104 | |
| United States, Texas | |
| Dallas Site | |
| Dallas, Texas, United States, 75201 | |
| United States, Washington | |
| Bellingham Site | |
| Whatcom County, Washington, United States, 98225 | |
| United States, Wisconsin | |
| Milwaukee Site | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Study Chair: | Harry Selker, MD, MSPH | Tufts Medical Center, Trial Coordinating Center |
| Principal Investigator: | Ralph D'Agostino, PhD | Tufts Medical Center, Data Coordinating Center |
| Principal Investigator: | James Udelson, MD | Tufts Medical Center, LV Core Lab |
More Information
| Responsible Party: | Tufts Medical Center ( Harry Selker, MD; Study Chair, Prinicpal Investigator ) |
| Study ID Numbers: | 165, U01 HL77821, U01 HL77822, U01 HL77823, U01 HL77826 |
| Study First Received: | September 9, 2004 |
| Last Updated: | December 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00091507 |
| Health Authority: | United States: Food and Drug Administration |
|
Acute Coronary Syndrome |
|
Arterial Occlusive Diseases Heart Failure Heart Diseases Myocardial Ischemia Angina Pectoris Vascular Diseases Pain Arteriosclerosis Ischemia Insulin |
Chest Pain Coronary Disease Signs and Symptoms Necrosis Acute Coronary Syndrome Emergencies Infarction Myocardial Infarction Angina, Unstable Coronary Artery Disease |
|
Disease Attributes Pathologic Processes Cardiovascular Diseases |
