Impact of Tight Glycaemic Control in Acute Myocardial Infarction

Hyperglycemia Clinical Trial

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

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

Related Conditions & MeSH terms

• Hyperglycemia
• Infarction
• Myocardial Infarct
• Myocardial Infarction

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