NCT00237471

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2005

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 12, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

July 21, 2011

Status Verified

July 1, 2011

Enrollment Period

7 months

First QC Date

October 10, 2005

Last Update Submit

July 19, 2011

Conditions

Myocardial InfarctHyperglycemia

Keywords

Acute Myocardial InfarctionHyperglycaemiaInsulin Infusion

Outcome Measures

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

Interventions

Insulin (tight blood glucose control)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>=18years
  • Acute Myocardial Infarction
  • Blood Glucose Level \>=10mmol/L
  • Wall motion abnormality on baseline echocardiogram

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Royal Melbourne Hospital

Melbourne, Victoria, 3050, Australia

Location

MeSH Terms

Conditions

Myocardial InfarctionHyperglycemia

Interventions

Insulin

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Leo Rando, MBBS FRACP

    Melbourne Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 10, 2005

First Posted

October 12, 2005

Study Start

October 1, 2005

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

July 21, 2011

Record last verified: 2011-07

Locations

AU(1)