This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Impact of Tight Glycaemic Control in Acute Myocardial Infarction

This study has been terminated.
(difficulty recruiting patients)
National Health and Medical Research Council, Australia
Bristol-Myers Squibb
Information provided by:
Melbourne Health Identifier:
First received: October 10, 2005
Last updated: July 19, 2011
Last verified: July 2011
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 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Melbourne Health:

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

Estimated Enrollment: 40
Study Start Date: October 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00237471

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
Principal Investigator: Leo Rando, MBBS FRACP Melbourne Health
  More Information

Responsible Party: Dr Leo Rando, Royal Melbourne Hospital Identifier: NCT00237471     History of Changes
Other Study ID Numbers: 2004.116
Study First Received: October 10, 2005
Last Updated: July 19, 2011

Keywords provided by Melbourne Health:
Acute Myocardial Infarction
Insulin Infusion

Additional relevant MeSH terms:
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 processed this record on September 20, 2017