Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
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
Secondary ID [1] 310450 0
MRFF2022811
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute coronary syndrome 331231 0
coronary artery disease 331232 0
Condition category
Condition code
Cardiovascular 327992 327992 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 326846 0
Early detection / Screening
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.
Control group
Historical

Outcomes
Primary outcome [1] 335868 0
Clinical effectiveness - the proportion of patients with any new cardiovascular medication measured using data linkage from electronic medical records to PBS and MBS data
Timepoint [1] 335868 0
At the conclusion of the study
Primary outcome [2] 335869 0
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.
Timepoint [2] 335869 0
At the conclusion of the study
Secondary outcome [1] 425938 0
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.
Timepoint [1] 425938 0
At the conclusion of the study
Secondary outcome [2] 429174 0
Health utility of the model of care measured by quality of life outcomes assessed using the EQ-5D
Timepoint [2] 429174 0
This outcome will be measured within one week of the index ED presentation and again at 3 months.
Secondary outcome [3] 429175 0
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.
Timepoint [3] 429175 0
At the conclusion of the study.

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Hybrid clinical and implementation effectiveness design
Pre- and post- implementation cohort
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 314657 0
Government body
Name [1] 314657 0
National Health and Medical Research Council
Country [1] 314657 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Office of Research, Kelvin Grove, QLD, 4059
Country
Australia
Secondary sponsor category [1] 317122 0
None
Name [1] 317122 0
Address [1] 317122 0
Country [1] 317122 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313675 0
Far North Queensland Human Research Ethics Committee
Ethics committee address [1] 313675 0
Ethics committee country [1] 313675 0
Australia
Date submitted for ethics approval [1] 313675 0
28/06/2023
Approval date [1] 313675 0
20/10/2023
Ethics approval number [1] 313675 0
HREC/2023/QCH/95510 (Oct ver 3) - 1730

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

Contacts
Principal investigator
Name 128974 0
Prof Louise Cullen
Address 128974 0
Emergency and Trauma Centre, Royal Brisbane and Women's Hospital, 22 Butterfield Street, Herston Road, Herston, Brisbane, QLD, 4006.
Country 128974 0
Australia
Phone 128974 0
+6173646 7901
Fax 128974 0
Email 128974 0
[email protected]
Contact person for public queries
Name 128975 0
Laura Stephensen
Address 128975 0
Australian Centre for Health Services Innovation, Queensland University of Technology, 60 Musk Avenue, Kelvin Grove QLD 4059
Country 128975 0
Australia
Phone 128975 0
+617 3138 0138
Fax 128975 0
Email 128975 0
[email protected]
Contact person for scientific queries
Name 128976 0
William Parsonage
Address 128976 0
Australian Centre for Health Services Innovation, Queensland University of Technology, 60 Musk Avenue, Kelvin Grove QLD 4059
Country 128976 0
Australia
Phone 128976 0
+61731380307
Fax 128976 0
Email 128976 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participant data will not be shared to maintain privacy and cultural protocols.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20758Ethical 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.