Impact of Tight Glycaemic Control in Acute Myocardial Infarction

• Sponsor: Melbourne Health (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00237471
• Collaborator: National Health and Medical Research Council, Australia (Other), Bristol-Myers Squibb (Industry)
• Enrollment: 40
• Location: 1
• Duration (Months): 7
• Patients Per Site Per Month: 5.7

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• 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: Oct 1, 2005
• Actual Primary Completion Date: May 1, 2006
• Actual Study Completion Date: May 1, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00237471
• Other Study ID Numbers: 2004.116; GEENA
• First Posted: Oct 12, 2005
• Last Update Posted: Jul 21, 2011
• Last Verified: Jul 1, 2011

• Keywords provided by , ,: Acute Myocardial Infarction; Hyperglycaemia; Insulin Infusion
• Additional relevant MeSH terms: Myocardial Infarction; Hyperglycemia; Infarction; Insulin

Study Results

No Results Posted as of Jul 21, 2011