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Trial registered on ANZCTR
Registration number
ACTRN12624000139572
Ethics application status
Approved
Date submitted
26/10/2023
Date registered
14/02/2024
Date last updated
14/02/2024
Date data sharing statement initially provided
14/02/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
The Powerful Pictures Study: Assessing Aboriginal and Torres Strait Islander people at risk of acute coronary syndrome with routine computer tomography coronary angiography
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Scientific title
Clinical and health economics implications of routine computer tomography coronary angiography for emergency department assessment of Aboriginal and Torres Strait Islander people at risk of acute coronary syndrome
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Secondary ID [1]
310450
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MRFF2022811
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
acute coronary syndrome
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coronary artery disease
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Condition category
Condition code
Cardiovascular
327992
327992
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0
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Coronary heart disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
In the intervention period, patients will be offered assessment in the new model of care which includes a radiological examination: computer tomography coronary angiogram (CTCA).. The model of care will be based upon the existing clinical assessment pathway for suspected acute coronary syndrome with the inclusion of CTCA and Calcium scoring (instead of exercise stress test). The co-design process for the model of care involves up to 36 consenting participants taking part in a one-hour qualitative interview to discuss elements of the model of care. Model of care elements include recruitment strategies, sharing of test results and education information with patients, linking of patients with existing or new primary care providers and other follow-up processes. Following the co-design process, the new model will be implemented.
Eligible participants for the new model of care will be identified by either senior clinical staff or directly by research staff. Research staff will approach potential participants and invite them to consent to take part in the research project as soon as possible but up to seven days following their index presentation
During the implementation period, consenting participants will receive a single CTCA scan procedure, lasting approximately 30 minutes, as either an inpatient or as soon as possible following their ED visit dependent on facility availability for testing. CTCA's will be conducted by trained radiology staff within the established service. The examination will include a non-contrast ECG-triggered acquisition for calcium scoring followed by a post-contrast ECG -gated acquisition covering the whole of the heart and the root of the aorta. The total radiation dose is anticipated to be <5mSv and will be monitored. An iodine-based contrast agent will be administered intravenously using the standard local procedure. The use of glyceryl trinitrate (GTN) for coronary artery dilatation will be used routinely and beta-blockers, or other rate-limiting drugs, may be administered to achieve a resting heart rate pre-acquisition <65 bpm.
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Intervention code [1]
326846
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Early detection / Screening
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Comparator / control treatment
The comparator group for the clinical outcomes of this study will be a pre-implementation cohort of Aboriginal and Torres Strait Islander people presenting to the emergency department of the Cairns, Weipa and Atherton Hospitals over a 12-month period from the 1st of July 2022 to the 30th of June 2023.
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Control group
Historical
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Outcomes
Primary outcome [1]
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Clinical effectiveness - the proportion of patients with any new cardiovascular medication measured using data linkage from electronic medical records to PBS and MBS data
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Assessment method [1]
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Timepoint [1]
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At the conclusion of the study
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Primary outcome [2]
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Implementation- the proportion of patients opting for Computer Tomography Coronary Angiography (CTCA) measured by prospectively collected data comparing the number of actual vs eligible participants. This outcome will be assessed by auditing study records to compare the proportion of participants eligible to take part in the study, with the proportion of participants who consented to the study.
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Assessment method [2]
335869
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Timepoint [2]
335869
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At the conclusion of the study
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Secondary outcome [1]
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Proportion of patients with CTCA findings of mild, moderate or severe coronary artery disease. This will be assessed as a composite outcome determined by cardiology adjudication of CTCA reported results.
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Assessment method [1]
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Timepoint [1]
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At the conclusion of the study
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Secondary outcome [2]
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Health utility of the model of care measured by quality of life outcomes assessed using the EQ-5D
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Assessment method [2]
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Timepoint [2]
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This outcome will be measured within one week of the index ED presentation and again at 3 months.
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Secondary outcome [3]
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Health care costs associated with the implementation of the new model of care inclusive of health service use Emergency Department (ED), Hospital, Medicare Benefits Schedule (MBS) and Pharmaceutical Benefits Scheme (PBS) and travel costs.
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Assessment method [3]
429175
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Timepoint [3]
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At the conclusion of the study.
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Eligibility
Key inclusion criteria
1) Identifies as Aboriginal and Torres Strait Islander origin
2) Presentation to an emergency department
3) Treating clinicians intends to investigate for possible acute coronary syndrome
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1) Diagnosis with acute myocardial infarction (AMI) during index presentation
2) Planned to undergo invasive coronary angiography
3) Known contradiction to CTCA: Severe renal failure; (serum creatinine >250 µmol/L or estimated glomerular filtration rate <30 mL/min/1.73 m2; contrast allergy; documented intolerance to rate limiting agent available; inability to breath hold; and atrial fibrillation (where mean heart rate is anticipated to be greater than 65/bpm after beta blockade)
4) History of previously documented coronary artery disease on invasive coronary angiography or CTCA
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
Hybrid clinical and implementation effectiveness design
Pre- and post- implementation cohort
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/07/2024
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Actual
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Date of last participant enrolment
Anticipated
30/06/2025
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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National Health and Medical Research Council
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Address [1]
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GPO Box 1421, Canberra City, ACT, 2601
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Queensland University of Technology
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Address
Office of Research, Kelvin Grove, QLD, 4059
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
317122
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Country [1]
317122
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Far North Queensland Human Research Ethics Committee
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Ethics committee address [1]
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Level 7, William McCormack Place 2, 5b Sheridan Street, Cairns QLD 4870
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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28/06/2023
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Approval date [1]
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20/10/2023
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Ethics approval number [1]
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HREC/2023/QCH/95510 (Oct ver 3) - 1730
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Summary
Brief summary
The Powerful Pictures study is an ambitious project which seeks to partner with First Nations Australians to co-design a new, improved model of care to identify and manage heart disease in patients at risk of future heart attacks. This model of care includes increasing access to a high-quality imaging test, Computed Tomography Coronary Angiography (CTCA) for the detection of early heart disease. The Powerful Pictures model of care will be co-designed with local communities, patients with lived experience of a possible heart attack, local clinicians, health workers, and health services managers and leadership. The model will then be implemented in regional (Cairns), outer regional (Atherton and Mareeba) and remote (Weipa) hospitals across Far North Queensland
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Trial website
https://www.aushsi.org.au/aushsi-research/the-powerful-pictures-study/
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Louise Cullen
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Address
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Emergency and Trauma Centre, Royal Brisbane and Women's Hospital, 22 Butterfield Street, Herston Road, Herston, Brisbane, QLD, 4006.
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Country
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Australia
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Phone
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+6173646 7901
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Ms Laura Stephensen
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Address
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Australian Centre for Health Services Innovation, Queensland University of Technology, 60 Musk Avenue, Kelvin Grove QLD 4059
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Country
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Australia
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Phone
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+617 3138 0138
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Prof William Parsonage
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Address
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Australian Centre for Health Services Innovation, Queensland University of Technology, 60 Musk Avenue, Kelvin Grove QLD 4059
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Country
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Australia
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Phone
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+61731380307
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Participant data will not be shared to maintain privacy and cultural protocols.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
20758
Ethical approval
386479-(Uploaded-26-10-2023-16-28-12)-Study-related document.pdf
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.
Download to PDF