Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000038099
Ethics application status
Approved
Date submitted
7/01/2010
Date registered
13/01/2010
Date last updated
15/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Measuring heart muscle oxygenation in chest pain syndromes
Scientific title
Measuring Impairments in Myocardial Oxygenation in Chest Pain Syndrome Patients using Blood-level Dependent Magnetic Resonance Imaging
Secondary ID [1] 1254 0
None
Universal Trial Number (UTN)
U1111-1113-1938
Trial acronym
BOLD-MRI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Left ventricular hypertrophy 256491 0
Hibernating myocardium 256492 0
Condition category
Condition code
Cardiovascular 256660 256660 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Stress imaging with cardiac magnetic resonance (CMR)with half of the subjects receiving adenosine intravenously(140mcg/kg/min) for 3-6 mins once only during the CMR and the other half receiving dobutamine intravenously (maximal dose-40mcg/kg/min) once only during CMR, all subjects have an echocardiograph once only either before or after the CMR, for those subjects in the hibernating part of the study , (those patients who will have a revascularisation either coronary artery bypass graftingor percutaneous coronary intervention) only adenosine (140mcg/kg/min) for 3-6 mins will be used during the CMR. These subjects will have two CMR's one at baseline and then one six months post revascularisation.
Intervention code [1] 255777 0
Diagnosis / Prognosis
Comparator / control treatment
20 age-sex matched volunteers will have stress imaging with 10 receiving intravenous adenosine and 10 receiving intravenous dobutamine, along with the cardiac magnetic resonance imaging and echocardiography. All 20 volunteers will be in the control group.
Control group
Active

Outcomes
Primary outcome [1] 257554 0
Patients with left ventricular hypertrophy presenting with chest pain and/or exertional breathlessness with normal epicardial arteries have direct impairments in myocardial tissue oxygenation. Perfusion reserve and blood-level dependent (BOLD) signal will be determined in the treatment group versus the control group. Assessed by cardiac magnetic resonance imaging and echocardiography.
Timepoint [1] 257554 0
Baseline
Primary outcome [2] 257555 0
Hibernating myocardial segments will maintain myocardial oxygenation levels similar to remote normal myocardium both in rest and stress. Regional wall motion, perfusion and oxygenation will be assessed by cardiac magnetic resonance imaging and echocardiography in the hibernating group versus the control group
Timepoint [2] 257555 0
Baseline and 6 months post revascularisation
Secondary outcome [1] 262798 0
none
Timepoint [1] 262798 0
none

Eligibility
Key inclusion criteria
1. History of hypertension, left ventricular hypertrophy, exertional chest pain and/or breathlessness, normal epicardial arteries
2. Known coronary artery disease, impaired regional left ventricular function awaiting percutaneous coronary intervention or coronary artery bypass grafting
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Inability to give written informed consent, estimated Glomerular Filtration Rate(GFR)<60mls/min, extreme claustrophobia, implantable cardiac devices and other contra-indications to Magnetic Resonance Imaging(MRI) (i.e. metal in eyes), asthma or other reversible bronchospasm

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
65
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256260 0
Charities/Societies/Foundations
Name [1] 256260 0
National Heart Foundation Grant-In-Aid
Country [1] 256260 0
Australia
Primary sponsor type
Hospital
Name
Southern Adelaide Health Service
Address
Laffer Drive
Science Park
BEDFORD PARK SA 5042
Country
Australia
Secondary sponsor category [1] 251590 0
None
Name [1] 251590 0
Address [1] 251590 0
Country [1] 251590 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258352 0
Flinders Clinical Research Ethics Committee
Ethics committee address [1] 258352 0
Flinders Medical Centre
Flinders Drive
BEDFORD PARK SA 5042
Ethics committee country [1] 258352 0
Australia
Date submitted for ethics approval [1] 258352 0
Approval date [1] 258352 0
20/02/2009
Ethics approval number [1] 258352 0
31/09

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

Contacts
Principal investigator
Name 30673 0
Address 30673 0
Country 30673 0
Phone 30673 0
Fax 30673 0
Email 30673 0
Contact person for public queries
Name 13920 0
Ms Christine Edwards
Address 13920 0
Department of Cardiovascular Medicine
Flinders Medical Centre
1 Flinders Drive,
BEDFORD PARK SA 5042
Country 13920 0
Australia
Phone 13920 0
+61 8 8204 5765
Fax 13920 0
+61 8 8204 7047
Email 13920 0
christine.edwards2@health sa.gov.au
Contact person for scientific queries
Name 4848 0
Professor Joseph Selvanayagam
Address 4848 0
Department of Cardiovascular Medicine
Flinders Medical Centre
1 Flinders Drive,
BEDFORD PARK SA 5042
Country 4848 0
Australia
Phone 4848 0
+61 8 8404 2195
Fax 4848 0
Email 4848 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
No additional documents have been identified.