Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000845336
Ethics application status
Approved
Date submitted
17/05/2017
Date registered
8/06/2017
Date last updated
8/06/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of insulin on blood flow to the heart during a heart attack.
Scientific title
The effect of hyperinsulinemic euglycemia on myocardial blood flow reserve in patients with obstructive coronary artery disease
Secondary ID [1] 291974 0
None
Universal Trial Number (UTN)
Trial acronym
EHEMI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocardial infarction 303317 0
Condition category
Condition code
Cardiovascular 302757 302757 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intravenous administration of rapid-acting human insulin (rDNA) 1.5mU/kg/minute for 2 hours with concurrent administration of 25% glucose intravenously (dose titrated according to blood glucose aiming for a blood glucose within 10% baseline and greater than 4mmol/L).
Intervention code [1] 298097 0
Treatment: Drugs
Comparator / control treatment
Usual guideline-directed care as per European Society of Cardiology and American College of Cardiology national guidelines.
Control group
Active

Outcomes
Primary outcome [1] 302145 0
Perfusion defect size assessed on myocardial contrast echocardiography.
Timepoint [1] 302145 0
24 hours post-treatment commencement.
Secondary outcome [1] 334963 0
Myocardial blood flow to remote non-ischaemic myocardial territories measured using myocardial contrast echocardiography.
Timepoint [1] 334963 0
24 hours post-treatment commencement.
Secondary outcome [2] 335626 0
ECG ST segment resolution.
Timepoint [2] 335626 0
ECG analysis at 30 minutes, 60 minutes, 120 minutes, and 24 hours after primary percutaneous coronary intervention.

Eligibility
Key inclusion criteria
Aged 18-80
Acute ST elevation myocardial infarction planned for primary percutaneous coronary intervention for mechanical revascularisation OR emergent percutaneous coronary intervention for failed pharmacological thrombolysis.
Able to provide written informed consent.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous coronary or cardiac valvular intervention.
On insulin therapy.
Cardiogenic shock.
Malignant life-threatening illness.

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)
Dice rolling.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Comparison of mean change in outcome measures using student t-test of wilcoxin test.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
9/10/2016
Date of last participant enrolment
Anticipated
17/08/2017
Actual
Date of last data collection
Anticipated
17/08/2017
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 8026 0
Sunshine Coast University Hospital - Birtinya
Recruitment postcode(s) [1] 16012 0
4575 - Birtinya

Funding & Sponsors
Funding source category [1] 296483 0
Charities/Societies/Foundations
Name [1] 296483 0
Wishlist Grant
Country [1] 296483 0
Australia
Funding source category [2] 296486 0
Commercial sector/Industry
Name [2] 296486 0
Novonordisk
Country [2] 296486 0
Australia
Primary sponsor type
Hospital
Name
Sunshine Coast University Hospital
Address
Sunshine Coast University Hospital
6 Doherty Street,
Birtinya
Qld 4575
Country
Australia
Secondary sponsor category [1] 295441 0
None
Name [1] 295441 0
Address [1] 295441 0
Country [1] 295441 0
Other collaborator category [1] 279576 0
University
Name [1] 279576 0
University of Queensland
Address [1] 279576 0
University of Queensland School of Medicine
Head Office - 288 Herston Road
Herston
Queensland 4006
Country [1] 279576 0
Australia
Other collaborator category [2] 279577 0
University
Name [2] 279577 0
University of Sunshine Coast
Address [2] 279577 0
University of Sunshine Coast
90 Sippy Downs Drive
Sippy Downs
Queensland 4556
Country [2] 279577 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297705 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 297705 0
PAH Centres for Health Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Ethics committee country [1] 297705 0
Australia
Date submitted for ethics approval [1] 297705 0
31/07/2015
Approval date [1] 297705 0
11/08/2015
Ethics approval number [1] 297705 0
HREC/15/QPAH/386

Summary
Brief summary
The effect of hyperinsulinemic euglycaemia (HE) on myocardial ischaemia is unknown. We have previously shown that HE increases myocardial blood flow in healthy individuals. We speculate that following successful revascularisation of a myocardial infarction, HE can improve microvascular flow to both ischaemic and remote non-ischaemic myocardial territories.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74894 0
Dr Michael Chi Yuan Nam
Address 74894 0
Sunshine Coast University Hospital
6 Doherty Street,
Birtinya
Qld 4575
Country 74894 0
Australia
Phone 74894 0
+61401946407
Fax 74894 0
Email 74894 0
[email protected]
Contact person for public queries
Name 74895 0
Dr Michael Nam
Address 74895 0
Sunshine Coast University Hospital
6 Doherty Street,
Birtinya
Qld 4575
Country 74895 0
Australia
Phone 74895 0
+61401946407
Fax 74895 0
Email 74895 0
[email protected]
Contact person for scientific queries
Name 74896 0
Dr Michael Nam
Address 74896 0
Sunshine Coast University Hospital
6 Doherty Street,
Birtinya
Qld 4575
Country 74896 0
Australia
Phone 74896 0
+61401946407
Fax 74896 0
Email 74896 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseAn Experimental Series Investigating the Effects of Hyperinsulinemic Euglycemia on Myocardial Blood Flow Reserve in Healthy Individuals and on Myocardial Perfusion Defect Size following ST-Segment Elevation Myocardial Infarction.2020https://dx.doi.org/10.1016/j.echo.2020.01.010
N.B. These documents automatically identified may not have been verified by the study sponsor.