Impact of Tight Glycaemic Control in Acute Myocardial Infarction

This study has been terminated.
(difficulty recruiting patients)
Sponsor:
Collaborators:
National Health and Medical Research Council, Australia
Bristol-Myers Squibb
Information provided by:
Melbourne Health
ClinicalTrials.gov Identifier:
NCT00237471
First received: October 10, 2005
Last updated: July 19, 2011
Last verified: July 2011
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00237471

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

No publications provided

Responsible Party: Dr Leo Rando, Royal Melbourne Hospital
ClinicalTrials.gov Identifier: NCT00237471     History of Changes
Other Study ID Numbers: 2004.116, GEENA
Study First Received: October 10, 2005
Last Updated: July 19, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Melbourne Health:
Acute Myocardial Infarction
Hyperglycaemia
Insulin Infusion

Additional relevant MeSH terms:
Hyperglycemia
Infarction
Myocardial Infarction
Glucose Metabolism Disorders
Metabolic Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014