Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00091507
Status:
COMPLETED
Last Update Posted:
2016-03-02
First Post:
2004-09-09
Brief Title:
IMMEDIATE Trial - Out of Hospital Administration of Glucose Insulin and Potassium
Sponsor:
Tufts Medical Center
Organization:
Tufts Medical Center
Study Overview
Official Title:
Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency Care Trial
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMMEDIATE
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 with threatened or established acute myocardial infarction AMI
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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HL077826 | NIH | None | None |
| U01HL077823 | NIH | None | None |
| U01HL077822 | NIH | None | None |
| U01HL077821 | NIH | None | httpsreporternihgovquickSearchU01HL077821 |