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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00237471
Other study ID # 2004.116
Secondary ID GEENA
Status Terminated
Phase Phase 4
First received October 10, 2005
Last updated July 19, 2011
Start date October 2005
Est. completion date May 2006

Study information

Verified date July 2011
Source Melbourne Health
Contact n/a
Is FDA regulated No
Health authority Australia: Department of Health and Ageing Therapeutic Goods Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 40
Est. completion date May 2006
Est. primary completion date May 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Insulin (tight blood glucose control)


Locations

Country Name City State
Australia The Royal Melbourne Hospital Melbourne Victoria

Sponsors (3)

Lead Sponsor Collaborator
Melbourne Health Bristol-Myers Squibb, National Health and Medical Research Council, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difference in the change in wall motion score index between admission, day 3-5 and after 3 months in the two treatment arms.
Secondary Changes in inflammatory/endothelial markers and myocardial perfusion from admission, day 3-5 and after 3 months between the two treatment arms
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