Impact of Tight Glycaemic Control in Acute Myocardial Infarction

NCT ID: NCT00237471

Last Updated: 2011-07-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2006-05-31

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.

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.

Conditions

Myocardial Infarct; Hyperglycemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Insulin (tight blood glucose control)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Health and Medical Research Council, Australia

OTHER

Sponsor Role: collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Melbourne Health

OTHER

Sponsor Role: lead

Responsible Party

Royal Melbourne Hospital

Principal Investigators

Leo Rando, MBBS FRACP

Role: PRINCIPAL_INVESTIGATOR

Melbourne Health

Locations

The Royal Melbourne Hospital

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

GEENA

Identifier Type: -

Identifier Source: secondary_id

2004.116

Identifier Type: -

Identifier Source: org_study_id