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Impact of Tight Glycaemic Control in Acute Myocardial Infarction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00237471
Recruitment Status : Terminated (difficulty recruiting patients)
First Posted : October 12, 2005
Last Update Posted : July 21, 2011
National Health and Medical Research Council, Australia
Bristol-Myers Squibb
Information provided by:
Melbourne Health

Brief Summary:
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 or disease Intervention/treatment Phase
Myocardial Infarct Hyperglycemia Drug: Insulin (tight blood glucose control) Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2005
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Difference in the change in wall motion score index between admission, day 3-5 and after 3 months in the two treatment arms.

Secondary Outcome Measures :
  1. Changes in inflammatory/endothelial markers and myocardial perfusion from admission, day 3-5 and after 3 months between the two treatment arms

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age >=18years
  • Acute Myocardial Infarction
  • Blood Glucose Level >=10mmol/L
  • Wall motion abnormality on baseline echocardiogram

Exclusion Criteria:

  • Active infection/inflammation
  • Cardiac shunt
  • Cognitive Impairment
  • Insulin allergy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00237471

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Australia, Victoria
The Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
Sponsors and Collaborators
Melbourne Health
National Health and Medical Research Council, Australia
Bristol-Myers Squibb
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Principal Investigator: Leo Rando, MBBS FRACP Melbourne Health

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Responsible Party: Dr Leo Rando, Royal Melbourne Hospital Identifier: NCT00237471    
Other Study ID Numbers: 2004.116
First Posted: October 12, 2005    Key Record Dates
Last Update Posted: July 21, 2011
Last Verified: July 2011
Keywords provided by Melbourne Health:
Acute Myocardial Infarction
Insulin Infusion
Additional relevant MeSH terms:
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Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs