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Trial registered on ANZCTR


Registration number
ACTRN12616001484437
Ethics application status
Approved
Date submitted
21/10/2016
Date registered
25/10/2016
Date last updated
24/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Performance comparison between ECG-gated 7 Tesla and clinical 1.5 Tesla Cardiac Magnetic Resonance Imaging in patients with cardiac scar tissue
Scientific title
7 Tesla UltraHigh Field ECG-gated Cardiac Magnetic Resonance Imaging in non-stented patients with cardiac scar tissue, for left ventricular (LV) and right ventricular (RV) volumetric assessment and scar quantitation
Secondary ID [1] 290314 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiac scar tissue from a prior myocardial infarct (MI) or a non-ischaemic myocardial injury (such as HCM, myocarditis or sarcoid), in patients without coronary artery stents 300577 0
Condition category
Condition code
Cardiovascular 300430 300430 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
7 Tesla (7T) Ultra-High Field Cardiac Magnetic Resonance Imaging (CMRI)
Participants will be recruited from patients with cardiac scar tissue undergoing routine clinical CMRI with gadolinium contrast agent at 1.5 Tesla. All recruited subjects will have an additional 7T CMRI with gadolinium contrast agent.
CMRI is a painless, non-invasive test that involves lying in a scanner. Each patient will first undergo one 1.5T scan of approximately 1 hour duration as part of their normal clinical care. Within 4 weeks of their clinical scan, consenting participants will be asked to come to the imaging facility at The Centre for Advanced Imaging, The University of Queensland. There they will undergo one additional 7T CMRI scan of approximately 1 hour duration.
The results of the clinical 1.5T CMRI scan and the experimental 7T CMRI scan will be compared to
1. evaluate the performance of 7T CMRI compared with standard CMRI at 1.5 T.
2. determine whether 7T CMRI can provide adequate images to measure heart function and scar tissue imaging.
Intervention code [1] 296196 0
Diagnosis / Prognosis
Comparator / control treatment
The 7T experimental scan is compared to a 1.5T clinical scan, performed on the same patient. The clinical CMRI scan, used as a comparator, is performed at 1.5 Tesla magnetic field strength with injection of gadolinium contrast agent and has a duration of approximately 1 hour. LV and RV volumes and the presence/absence of myocardial enhancement are assessed.
Control group
Active

Outcomes
Primary outcome [1] 299939 0
Sensitivity and specificity of 7T in comparison to 1.5T
Timepoint [1] 299939 0
At time of second scan
Secondary outcome [1] 328590 0
Quantitation of myocardial enhancement (FWHM or signal thresholding) at 1.5T vs 7T
Timepoint [1] 328590 0
at time of second scan

Eligibility
Key inclusion criteria
Patients scheduled for a clinical CMRI on 1.5T MR scanner, having scar tissue from a prior myocardial infarct (MI) or a non-ischaemic myocardial injury (such as HCM, myocarditis or sarcoid)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Subject has MRI non-conditional metal implant, such as a pacemaker
(2) Subject has significant kidney impairment;
(3) Subject has coronary artery stent implanted;
(4) Subject has severe allergy to Gadolinium (Gd) contrast agent;
(5) Subject has claustrophobia;
(6) Subject is pregnant or breastfeeding;
(7) Subject is less than 18 years old.

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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The following parameters will be measured and calculated from CMRI results:
1. Left ventricular (LV) volume fraction and ejection fraction (LVEF);
2. Right ventricular (RV) volume fraction and ejection fraction (RVEF);
3. Left ventricular mass (LV mass);
4. Pulmonary artery flow and stroke volume;
5. Aortic flow and stroke volume;
6. Non-contrast Native T1 mapping (if available);
7. End-diastolic mass;
8. End-systolic mass and;
9. Extracellular volume fraction.
An ANOVA will be carried out to test whether the measurements of each participant are internally consistent (for example, arterial stroke volumes are similar to ventricular stroke volumes) and across magnetic field strength. The multiple comparisons problem will be controlled using a Bonferroni adjustment, with the Family Wise Error Rate restricted to 0.05.
Finally, the Bland-Altman method will be used to examine the relationship between the measurements of the parameters at different field strength (that is, 1.5T versus 7.0T).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/01/2017
Actual
Date of last participant enrolment
Anticipated
28/02/2017
Actual
Date of last data collection
Anticipated
31/03/2017
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 6825 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 14487 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 294698 0
University
Name [1] 294698 0
The University of Queensland
Country [1] 294698 0
Australia
Funding source category [2] 294699 0
Charities/Societies/Foundations
Name [2] 294699 0
The Prince Charles Hospital Foundation
Country [2] 294699 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland
Brisbane St Lucia, QLD 4072
Country
Australia
Secondary sponsor category [1] 293544 0
None
Name [1] 293544 0
Address [1] 293544 0
Country [1] 293544 0
Other collaborator category [1] 279266 0
Hospital
Name [1] 279266 0
The Prince Charles Hospital
Address [1] 279266 0
The Prince Charles Hospital
627 Rode Road, Chermside QLD 4032
Country [1] 279266 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296130 0
The Prince Charles Hospital HREC (EC00168)
Ethics committee address [1] 296130 0
Ethics committee country [1] 296130 0
Australia
Date submitted for ethics approval [1] 296130 0
13/09/2016
Approval date [1] 296130 0
02/11/2016
Ethics approval number [1] 296130 0
HREC/16/QPCH/140
Ethics committee name [2] 296131 0
The University of Queensland Medical Research Ethics Committee (EC00179)
Ethics committee address [2] 296131 0
Ethics committee country [2] 296131 0
Australia
Date submitted for ethics approval [2] 296131 0
15/09/2016
Approval date [2] 296131 0
Ethics approval number [2] 296131 0

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

Contacts
Principal investigator
Name 69638 0
A/Prof Christian Hamilton-Craig
Address 69638 0
Medical Imaging
The Prince Charles Hospital
627 Rode Road, Chermside QLD 4032
Country 69638 0
Australia
Phone 69638 0
+61 7 31395226
Fax 69638 0
Email 69638 0
[email protected]
Contact person for public queries
Name 69639 0
Sabine Fletcher
Address 69639 0
The University of Queensland
Centre for Advanced Imaging, Building 57
St Lucia QLD 4072
Country 69639 0
Australia
Phone 69639 0
+61 7 3365 4100
Fax 69639 0
Email 69639 0
[email protected]
Contact person for scientific queries
Name 69640 0
Christian Hamilton-Craig
Address 69640 0
Medical Imaging
The Prince Charles Hospital
627 Rode Road, Chermside QLD 4032
Country 69640 0
Australia
Phone 69640 0
+61 7 31395226
Fax 69640 0
Email 69640 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
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Documents added automatically
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