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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00237471




Registration number
NCT00237471
Ethics application status
Date submitted
10/10/2005
Date registered
12/10/2005
Date last updated
21/07/2011

Titles & IDs
Public title
Impact of Tight Glycaemic Control in Acute Myocardial Infarction
Scientific 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
Secondary ID [1] 0 0
GEENA
Secondary ID [2] 0 0
2004.116
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocardial Infarct 0 0
Hyperglycemia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Insulin (tight blood glucose control)

Treatment: Drugs: Insulin (tight blood glucose control)


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Difference in the change in wall motion score index between admission, day 3-5 and after 3 months in the two treatment arms.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Changes in inflammatory/endothelial markers and myocardial perfusion from admission, day 3-5 and after 3 months between the two treatment arms
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- Age >=18years

- Acute Myocardial Infarction

- Blood Glucose Level >=10mmol/L

- Wall motion abnormality on baseline echocardiogram
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Active infection/inflammation

- Cardiac shunt

- Cognitive Impairment

- Insulin allergy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3050 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Melbourne Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Bristol-Myers Squibb
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT00237471
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Leo Rando, MBBS FRACP
Address 0 0
Melbourne Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00237471