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TerminatedNCT00237471Updated Jul 21, 2011

Impact of Tight Glycaemic Control in Acute Myocardial Infarction

A Phase 4 interventional study of Insulin (tight blood glucose control) in Myocardial Infarct and Hyperglycemia, sponsored by Melbourne Health. Terminated at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-07-21.

Sponsored by Melbourne Health · Phase 4, Interventional, and Treatment

Why this study was terminated
difficulty recruiting patients
Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Myocardial Infarct
  • Hyperglycemia

Keywords

  • Acute Myocardial Infarction
  • Hyperglycaemia
  • Insulin Infusion
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's enrollment of 40 is below the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

Melbourne Health is the lead sponsor of 59 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Active infection/inflammation
  • Cardiac shunt
  • Cognitive Impairment
  • Insulin allergy
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants

Interventions

  • DrugInsulin (tight blood glucose control)
06

What researchers measure

Primary outcomes

  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 outcomes

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

07

Study locations

1 site
  • The Royal Melbourne Hospital
    Melbourne, Victoria 3050, Australia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00237471
Lead sponsor
Melbourne Health
Collaborators
National Health and Medical Research Council, Australia, Bristol-Myers Squibb
First posted
Oct 12, 2005
Start date
Oct 2005
Primary completion
May 2006
Completion
May 2006
Last update
Jul 21, 2011

Study contacts

Leo Rando, MBBS FRACP
principal investigator · Melbourne Health
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

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