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| Sponsors and Collaborators: |
Melbourne Health National Health and Medical Research Council, Australia Bristol-Myers Squibb |
|---|---|
| Information provided by: | Melbourne Health |
| ClinicalTrials.gov Identifier: | NCT00237471 |
Purpose
To determine whether tight glycaemic control with insulin improves myocardial function and myocardial perfusion (measured by myocardial contrast echocardiography) and novel vascular risk factors in patients with acute myocardial infarction and hyperglycaemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Myocardial Infarct Hyperglycemia |
Drug: Insulin (tight blood glucose control) |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Impact of Tight Glycaemic Control With Insulin on Novel Vascular Disease Risk Factors and Myocardial Function and Perfusion in Acute Myocardial Infarction Patients With Hyperglycaemia |
| Estimated Enrollment: | 40 |
| Study Start Date: | October 2005 |
We will randomise patients with acute myocardial infarction and blood glucose levels (BGLs) >=10mmol/L within 24 hours of pain onset, to either tight glucose control (aiming BGLs 4.5 - 7mmol/L) with an insulin infusion (for 24 hours) followed by subcutaneous insulin or standard control (BGL 6 - 12mmol/L) without the use of an insulin infusion. Serial myocardial contrast echocardiography will measure changes in myocardial perfusion and function from baseline to 3 months between each group. We will also measure changes in inflammatory and endothelial markers over this time to see whether tight glucose control improves these surrogate endpoints.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Leo Rando, MBBS FRACP | +61 3 9342 7365 | leo.rando@mh.org.au |
| Contact: Peter G Colman, MD FRACP | +61 3 9342 7268 | peter.colman@mh.org.au |
| Australia, Victoria | |
| The Royal Melbourne Hospital | Recruiting |
| Melbourne, Victoria, Australia, 3050 | |
| Contact: Leo Rando, MBBS FRACP +61 3 9342 7365 leo.rando@mh.org.au | |
| Contact: Peter Colman, MD FRACP + 61 3 9342 7365 peter.colman@mh.org.au | |
| Principal Investigator: Leo Rando, MBBS FRACP | |
| Principal Investigator: | Leo Rando, MBBS FRACP | Melbourne Health |
More Information
| Study ID Numbers: | 2004.116, GEENA |
| Study First Received: | October 10, 2005 |
| Last Updated: | October 26, 2005 |
| ClinicalTrials.gov Identifier: | NCT00237471 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
|
Acute Myocardial Infarction Hyperglycaemia Insulin Infusion |
|
Necrosis Heart Diseases Metabolic Diseases Hyperglycemia Myocardial Ischemia Vascular Diseases |
Ischemia Metabolic disorder Glucose Metabolism Disorders Infarction Myocardial Infarction Insulin |
|
Hypoglycemic Agents Pathologic Processes Physiological Effects of Drugs Cardiovascular Diseases Pharmacologic Actions |
