Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000097246
Ethics application status
Approved
Date submitted
19/12/2008
Date registered
11/02/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Reproducibility of Perfusion Cardiac Magnetic Resonance Imaging
Scientific title
Reproducibility of First Pass Perfusion Cardiac Magnetic Resonance Imaging in Multivessel Symptomatic Coronary Artery Disease
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary artery disease 4146 0
Condition category
Condition code
Cardiovascular 4351 4351 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
First pass perfusion cardiac magnetic resonance imaging (CMR) to be performed in 2 groups of particpants: (1) Coronary artery disease group (2) Healthy Volunteer Control group.
Each subject will undergo two CMR examinations performed on two separate occasions up to two weeks apart. CMR
examinations will be performed on a 1.5 Tesla scanner under the supervision of a physician and noninvasive cardiac
monitoring. Subjects will be prepared with two peripheral intravenous cannulae. Each examination will involve assessment of resting ventricular function, first-pass myocardial perfusion and and delayed enhancement imaging for infarct diagnosis. First-pass perfusion data and delayed enhancement will be acquired using 0.05mmol/kg (5ml/sec infusion rate) of Gd-DTPA, with images obtained in the three standard short axis planes. Pharmacologic stress will be induced with adenosine administered as an intravenous infusion (0.14mg/kg/min), commenced up to four minutes prior to the commencement of the acquisition. To ensure maximal vasodilatory response to adenosine, all caffeinated beverages will be withheld for 24 hours prior.
Myocardial perfusion analysis will be performed on a Phillips EasyVision Platform. Images will be assessed
qualitatively and semiquantitatively.
Intervention code [1] 3862 0
Diagnosis / Prognosis
Comparator / control treatment
First pass perfusion cardiac magnetic resonance imaging (CMR) (as performed in Coronary artery disase participant group) in healthy volunteer group
Control group
Active

Outcomes
Primary outcome [1] 5230 0
Reproducibility of qualitative and semiquantitative analysis of first pass perfusion CMR in patients with multivessel disease. Reproducibility assessed by coefficeint of variation and the Bland-Altman method
Timepoint [1] 5230 0
After the second first pass perfusion CMR for each participant has been undertaken.
Secondary outcome [1] 8813 0
Compare reproducibility of first pass perfusion CMR in patients with multivessel diesase versus those with low risk coronary artery disease. Unpaired t-tests will be used to assess for differences in reprodcubility between these 2 groups
Timepoint [1] 8813 0
After the second first pass perfusion CMR for each participant has been undertaken

Eligibility
Key inclusion criteria
A. Coronary artery disease subgroup
1. Established multivessel coronary artery disease on angiography
2. Canadian cardiovascular society class II-IV angina

B. Healthy volunteer subgroup
1. Low risk for coronary artery disease based on a Framingham estimated 10 year coronary heart disease risk of <10%
2. Male or female, age >50years
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Patients in whom cardiac medical or surgical interventions are likely to occur during the intervening period between the 2 CMR examinations
2. Patients with MR incompatible implants eg. permanent pacemaker
3. Severe claustrophobia
4. Contraindications to adenosine
5. Chronic Atrial fibrillation
6. Unstable angina or myocardial infarction within 7 days
7. Patients with significant renal impairment (glomerular filtration rate <60mL/min

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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4318 0
Other
Name [1] 4318 0
Victor Chang Cardiac Research Institute
Country [1] 4318 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital
Address
390 Victoria Street
Darlinghurst
NSW, 2010
Country
Australia
Secondary sponsor category [1] 3888 0
None
Name [1] 3888 0
Address [1] 3888 0
Country [1] 3888 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6365 0
St Vincent's Hospital
Ethics committee address [1] 6365 0
Ethics committee country [1] 6365 0
Australia
Date submitted for ethics approval [1] 6365 0
Approval date [1] 6365 0
Ethics approval number [1] 6365 0
08/SVH/167

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

Contacts
Principal investigator
Name 35052 0
Address 35052 0
Country 35052 0
Phone 35052 0
Fax 35052 0
Email 35052 0
Contact person for public queries
Name 12399 0
Sharon Chih
Address 12399 0
Victor Chang Cardiac Research Institute
Lowy Packer Building
405 Liverpool Street
Darlinghurst
NSW 2010
Country 12399 0
Australia
Phone 12399 0
+61 2 9295 8600
Fax 12399 0
Email 12399 0
[email protected]
Contact person for scientific queries
Name 3327 0
Sharon Chih
Address 3327 0
Victor Chang Cardiac Research Institute
Lowy Packer Building
405 Liverpool Street
Darlinghurst
NSW 2010
Country 3327 0
Australia
Phone 3327 0
+61 9295 8600
Fax 3327 0
Email 3327 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.