Trial Review

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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
ACTRN12625000687493p
Ethics application status
Submitted, not yet approved
Date submitted
7/06/2025
Date registered
27/06/2025
Date last updated
27/06/2025
Date data sharing statement initially provided
27/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Aortic stenosis screening using artificial intelligence in adults 65 years and older living in rural and remote communities
Scientific title
Feasibility of Aortic Stenosis Screening Using artificial intelligence to acquire and interpret Echocardiograms in adults 65 years and older living in rural and remote communities
Secondary ID [1] 314609 0
None
Universal Trial Number (UTN)
Trial acronym
ASSURE-Echo
Linked study record

Health condition
Health condition(s) or problem(s) studied:
aortic stenosis 337743 0
Condition category
Condition code
Cardiovascular 334073 334073 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial will use artificial intelligence-based software (UltraSight, Boston, MA, and Caption Care, San Mateo, CA) to facilitate acquisition of a single 2D echocardiogram using standard ultrasound equipment (Lumify, Philips, Netherlands; Terason, Burlington, MA). The acquisition-artificial intelligence facilitates the decision to capture a 2-dimensional image based on recognising features pointing towards the adequacy of that image. These acquisitions will be obtained by non-experts (eg registered nurses, general practitioners).
The resulting 2D images will be interpreted by cardiologists in conjunction with artificial intelligence-based software (EchoCLIP, Cedars-Sinai, Los Angeles, CA). The interpretive artificial intelligence facilitates recognition of aortic stenosis by picking up patterns on the ultrasound image that are associated with aortic stenosis.
It is planned to study 1000 people >65 years old over 12 months (August 2025-August 2026), in primary care and research facilities in Australia (Tasmania and possibly Victoria and Western Australia).
All images will be collected by the core laboratory to assess the completeness of the echocardiogram and adequacy of interpretation.
Intervention code [1] 331236 0
Early detection / Screening
Comparator / control treatment
Use of standard auscultation using a recorded stethoscope for offline interpretation of the recording by a clinician.
Control group
Active

Outcomes
Primary outcome [1] 341734 0
Feasibility, determined via rates of aortic stenosis diagnosed
Timepoint [1] 341734 0
12 months post-randomisation
Secondary outcome [1] 448553 0
Resource utilization
Timepoint [1] 448553 0
12 months post-randomisation
Secondary outcome [2] 448550 0
Cardiac valve review
Timepoint [2] 448550 0
12 months post-randomisation
Secondary outcome [3] 448551 0
Composite secondary outcome of any symptoms of aortic stenosis (exertional dyspnoea, angina or syncope)
Timepoint [3] 448551 0
12 months post-randomisation
Secondary outcome [4] 448552 0
Health related quality of life
Timepoint [4] 448552 0
12 months post-randomisation

Eligibility
Key inclusion criteria
Age >=65 years, Medicare-eligible, living in rural and remote communities (Monash category 2 and above)
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Known heart valve disease, comorbid conditions with life expectancy <2 years, inability to provide written informed consent.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
There will be pairwise comparison of AS detection from AI-echo vs usual care (recorded auscultation), with the reference standard being confirmation of AS from downstream echocardiography. The primary endpoint will be based on McNemar’s test for paired categorical data. This will be supplemented using logistic regression models to adjust for confounders. Secondary binary outcomes will be analysed similarly, with the mean difference in continuous outcomes compared between groups using linear regression models additionally adjusted for baseline values. Standard diagnostic plots will be used to assess validity of assumptions, and multiple imputation will be applied to deal with missing data in a secondary analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2025
Actual
Date of last participant enrolment
Anticipated
31/07/2026
Actual
Date of last data collection
Anticipated
31/07/2028
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 319169 0
Charities/Societies/Foundations
Name [1] 319169 0
HCF Foundation
Country [1] 319169 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
Country
Australia
Secondary sponsor category [1] 321628 0
None
Name [1] 321628 0
Address [1] 321628 0
Country [1] 321628 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317751 0
University of Tasmania Human Research Ethics Committee
Ethics committee address [1] 317751 0
Ethics committee country [1] 317751 0
Australia
Date submitted for ethics approval [1] 317751 0
29/05/2025
Approval date [1] 317751 0
Ethics approval number [1] 317751 0

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

Contacts
Principal investigator
Name 142022 0
Prof Thomas Marwick
Address 142022 0
Menzies Institute for Medical Research, 17 Liverpool St, Hobart, Tas 7000
Country 142022 0
Australia
Phone 142022 0
+61 427 157 975
Fax 142022 0
Email 142022 0
[email protected]
Contact person for public queries
Name 142023 0
Thomas Marwick
Address 142023 0
Menzies Institute for Medical Research, 17 Liverpool St, Hobart, Tas 7000
Country 142023 0
Australia
Phone 142023 0
+61 427 157 975
Fax 142023 0
Email 142023 0
[email protected]
Contact person for scientific queries
Name 142024 0
Thomas Marwick
Address 142024 0
Menzies Institute for Medical Research, 17 Liverpool St, Hobart, Tas 7000
Country 142024 0
Australia
Phone 142024 0
+61 427 157 975
Fax 142024 0
Email 142024 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.