Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000022662
Ethics application status
Approved
Date submitted
12/07/2005
Date registered
18/07/2005
Date last updated
18/07/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
Glucose normalization Effects on Echo and Novel vascular markers in Acute myocardial infarction
Scientific title
Impact of tight glycaemic control with insulin on novel vascular markers and myocardial function and perfusion in acute myocardial infarction patients with hyperglycaemia
Universal Trial Number (UTN)
Trial acronym
GEENA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperglycaemia post non ST elevation myocardial infarction. 84 0
Condition category
Condition code
Cardiovascular 105 105 0 0
Other cardiovascular diseases
Blood 106 106 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
"Intensive treatment" (intravenous insulin infusion for 24 hours followed by tight glycaemic control aiming BGL 4.5 - 7mmol/L throughout admission).
Intervention code [1] 10 0
None
Comparator / control treatment
"Standard treatment" (Aiming for BGL 6 - 12mmol/L throughout admission without the use of an insulin infusion).
Control group
Placebo

Outcomes
Primary outcome [1] 132 0
Differences in the change in wall motion score index (by contrast echocardiography) between admission, day 3-5 and after 3 months.
Timepoint [1] 132 0
Between admission, day 3-5 and after 3 months
Secondary outcome [1] 293 0
Changes in inflammatory markers
Timepoint [1] 293 0
At admission, day 1, day 3-5 and 3 months.
Secondary outcome [2] 294 0
Changes in myocardial perfusion
Timepoint [2] 294 0
From admission to day 3-5 and 3 months.

Eligibility
Key inclusion criteria
Non ST Non ST elevation myocardial infarct within 24 hoursBGL >=10mmol/Lelevation myocardial infarct within 24 hoursBGL >=10mmol/L
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current infection; Active inflammatory conditions; Women of child bearing potential; Known cardiac shuntInsulin 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)
Balanced randomisation will be performed using permuted blocks based upon 3 stratification variables at baseline (eg 8 possible strata): (1) age >=65 years (2) ejection fraction >grade 2 (3)diabetes. Random binary digit sequences will be generated using Stata statistical software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/10/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 139 0
Commercial sector/Industry
Name [1] 139 0
Bristol-Myers-Squibb Medical Imaging Physician Initiated Clinical Research Grant
Country [1] 139 0
Funding source category [2] 140 0
Government body
Name [2] 140 0
NHMRC post-graduate scholarship
Country [2] 140 0
Australia
Primary sponsor type
Government body
Name
Melbourne Health
Address
Country
Australia
Secondary sponsor category [1] 100 0
None
Name [1] 100 0
Nil
Address [1] 100 0
Country [1] 100 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36134 0
Address 36134 0
Country 36134 0
Phone 36134 0
Fax 36134 0
Email 36134 0
Contact person for public queries
Name 9199 0
Dr Angela Watt
Address 9199 0
Research Directorate
Melbourne Health
The Royal Melbourne Hospital
Grattan St
Parkville VIC 3050
Country 9199 0
Australia
Phone 9199 0
+61 3 93427550
Fax 9199 0
Email 9199 0
angela.watt@mh.org.au
Contact person for scientific queries
Name 127 0
Dr Leo Rando
Address 127 0
Department of Diabetes and Endocrinology
The Royal Melbourne Hospital
Grattan St
Parkville VIC 3050
Country 127 0
Australia
Phone 127 0
+61 3 93427365
Fax 127 0
Email 127 0
leo.rando@mh.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.