Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000047796
Ethics application status
Approved
Date submitted
17/11/2021
Date registered
17/01/2022
Date last updated
28/01/2022
Date data sharing statement initially provided
17/01/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cardiac and vascular Evaluation using 4D-flow magnetic resonance (4DCARE).
Scientific title
Four-dimensional flow MRI for cardiovascular evaluation (4DCARE): a prospective non-inferiority trial of a rapid cardiac MRI exam
Secondary ID [1] 305606 0
Nil known
Universal Trial Number (UTN)
U1111-1270-6509
Trial acronym
4DCare
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac MRI 324038 0
Heart failure or any criterion where cardiac magnetic resonance is clinically indicacted 324039 0
Condition category
Condition code
Cardiovascular 321540 321540 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients referred by their doctor for Cardiovascular magnetic resonance imaging are invited to participate in the study.
Participants undergo a single imaging session including both the compressed 4D-flow protocol (4DCARE-CP), and the complete conventional Cardiovascular magnetic resonance imaging protocol (CMR-FP).
The study exam time is equal to the standard length of a typical cardiac MRI exam as the 20 minute 4D-flow protocol is nested within a total 45 min exam time.
Intervention code [1] 322008 0
Diagnosis / Prognosis
Comparator / control treatment
The compressed 4D-flow protocol (4DCARE-CP) will be compared to the complete conventional Cardiovascular magnetic resonance imaging protocol (CMR-FP).
Control group
Active

Outcomes
Primary outcome [1] 329306 0
Measurement of key metrics for quantification of cardiac size and function.
Timepoint [1] 329306 0
4D-flow MRI and conventional Cardiovascular magnetic resonance imaging data will be obtained at time of scanning.
Secondary outcome [1] 402089 0
Assessment of the overall diagnostic equivalence of the 20 min 4D-flow protocol to the conventional cardiac MRI protocol.
Timepoint [1] 402089 0
Assessment will be made at the end of the study based on data obtained at the time of scanning.

Eligibility
Key inclusion criteria
Adults with an indication for cardiac MRI
Minimum age
0 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Thoracic metallic implant (including pacemaker, cardiac defibrillation device)
Inability to tolerate exam
Other contraindication to MRI (including contraindication to IV contrast)

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The expected improvement in flow determination with 4D-flow is an approximate halving of
the “flow balance” error (discrepancy between aortic flow and pulmonary flow – in the
absence of a shunt these should be equal measurements), and a similar reduction the
variance of the individual flow measures (aortic and pulmonary flow). It is harder to estimate
the real world performance of the volume measurements with the single breath-hold cine
sequence, but our early data shows them to be similar in variance.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/08/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/02/2022
Actual
Sample size
Target
800
Accrual to date
750
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 20815 0
Macquarie University Hospital - Macquarie Park
Recruitment hospital [2] 20816 0
Sydney Adventist Hospital - Wahroonga
Recruitment hospital [3] 20817 0
Epworth Hospital Geelong - Waurn Ponds
Recruitment hospital [4] 20818 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment postcode(s) [1] 35635 0
2076 - Wahroonga
Recruitment postcode(s) [2] 35634 0
2109 - Macquarie Park
Recruitment postcode(s) [3] 35636 0
3216 - Waurn Ponds
Recruitment postcode(s) [4] 35637 0
3220 - Geelong

Funding & Sponsors
Funding source category [1] 309969 0
Other
Name [1] 309969 0
Imaging and Phenotyping Laboratory
Country [1] 309969 0
Australia
Primary sponsor type
Other
Name
Imaging and Phenotyping Laboratory
Address
The University of Sydney
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 311014 0
Other Collaborative groups
Name [1] 311014 0
Imaging Core Labs (iCore)
Address [1] 311014 0
c/o Chrysalis Advisory
Suite 2, Level 7, 431 King William Street, Adelaide, South Australia 5000
Country [1] 311014 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309680 0
Epworth HealthCare/Monash Health Human Research Ethics Committee
Ethics committee address [1] 309680 0
Monash Health
Level 2, I Block
Monash Medical Centre
246 Clayton Road
Clayton Victoria 3168
Ethics committee country [1] 309680 0
Australia
Date submitted for ethics approval [1] 309680 0
Approval date [1] 309680 0
24/07/2017
Ethics approval number [1] 309680 0
EH2017-177 / RES-19-0000-195E
Ethics committee name [2] 309687 0
Macquarie University Human Research Ethics Committee
Ethics committee address [2] 309687 0
Research Office
Research Hub, Building C5C East
Macquarie University
NSW 2109
Ethics committee country [2] 309687 0
Australia
Date submitted for ethics approval [2] 309687 0
Approval date [2] 309687 0
06/09/2017
Ethics approval number [2] 309687 0
5201700788
Ethics committee name [3] 309688 0
Adventist HealthCare Human Research Ethics Committee
Ethics committee address [3] 309688 0
185 Fox Valley Road
Wahroonga
NSW 2076
Ethics committee country [3] 309688 0
Australia
Date submitted for ethics approval [3] 309688 0
Approval date [3] 309688 0
06/03/2018
Ethics approval number [3] 309688 0
HREC 2017-036

Summary
Brief summary
To perform a prospective non-inferiority study of a rapid cardiac MRI acquisition protocol using 4D-flow compared to the current gold standard cardiac MRI examination to measure cardiac function and detect pathology
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115018 0
Prof Stuart M.Grieve
Address 115018 0
D17 Charles Perkin Centre
University of Sydney
Camperdown NSW 2006
Country 115018 0
Australia
Phone 115018 0
+61286271616
Fax 115018 0
Email 115018 0
stuart.grieve@sydney.edu.au
Contact person for public queries
Name 115019 0
Prof Stuart M.Grieve
Address 115019 0
D17 Charles Perkin Centre
University of Sydney
Camperdown NSW 2006
Country 115019 0
Australia
Phone 115019 0
+61286271616
Fax 115019 0
Email 115019 0
stuart.grieve@sydney.edu.au
Contact person for scientific queries
Name 115020 0
Prof Stuart M.Grieve
Address 115020 0
D17 Charles Perkin Centre
University of Sydney
Camperdown NSW 2006
Country 115020 0
Australia
Phone 115020 0
+61286271616
Fax 115020 0
Email 115020 0
stuart.grieve@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Impracticality to share large digital imaging data.


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
Dimensions AIRaw Materials, Technology, Healthcare Applications, Patent Repository and Clinical Trials on 4D Printing Technology: An Updated Review2022https://doi.org/10.3390/pharmaceutics15010116
N.B. These documents automatically identified may not have been verified by the study sponsor.