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Impact of Tight Glycaemic Control in Acute Myocardial Infarction

Primary Purpose

Myocardial Infarct, Hyperglycemia

Status

Terminated

Phase

Phase 4

Locations

Australia

Study Type

Interventional

Intervention

Insulin (tight blood glucose control)

About this trial

This is an interventional treatment trial for Myocardial Infarct focused on measuring Acute Myocardial Infarction, Hyperglycaemia, Insulin Infusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The Royal Melbourne Hospital

Outcomes

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

Full Information

NCT ID

NCT00237471

First Posted

October 10, 2005

Last Updated

July 19, 2011

Sponsor

Melbourne Health

Collaborators

National Health and Medical Research Council, Australia, Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT00237471

Brief Title

Impact of Tight Glycaemic Control in Acute Myocardial Infarction

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 Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Terminated

Why Stopped

difficulty recruiting patients

Study Start Date

October 2005 (undefined)

Primary Completion Date

May 2006 (Actual)

Study Completion Date

May 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Melbourne Health

Collaborators

National Health and Medical Research Council, Australia, Bristol-Myers Squibb

4. Oversight

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Infarct, Hyperglycemia

Keywords

Acute Myocardial Infarction, Hyperglycaemia, Insulin Infusion

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Insulin (tight blood glucose control)

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leo Rando, MBBS FRACP

Organizational Affiliation

Melbourne Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Royal Melbourne Hospital

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3050

Country

Australia

12. IPD Sharing Statement

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Impact of Tight Glycaemic Control in Acute Myocardial Infarction

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