Trial Review

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
Help: Registration number
ACTRN12626001147370
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
21/07/2026
Date registered
Help: Date registered
15/09/2026
Date last updated
Help: Date last updated
15/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
15/09/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
Advancing Ultrasound Imaging of the Heart using Computer Models in Adults
Scientific title
Clinical translation of biophysical modelling for intelligent echocardiography: a prospective observational study investigating the application of deep learning to three-dimensional echocardiogram analysis in adults
Additional trial identifiers [1] 317973 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
heart disease 342943 0
Condition category
Condition code
Cardiovascular 339062 339062 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
2
Target follow-up type
Years
Description of the intervention or exposure
Patients undergoing clinically indicated transthoracic echocardiography will be studied prospectively. The data collected for the study will consist of copies of the all echocardiographic images and measurements acquired routine clinical care. These may include two-dimensional (2D), three-dimensional (3D), and Doppler (pulsed-wave, continuous-wave and colour Doppler) imaging acquired from standard parasternal, apical, subcostal, and suprasternal views. Routine echocardiographic measurements will be made according to standard clinical echocardiography recommendations. The echocardiographic image acquisition is the same as that undertaken as part of routine clinical care; no additional images or measurements are acquired from the participant solely for research purposes. No study-mandated examinations are required. Any further echocardiographic examinations undertaken during follow-up will occur only as part of routine clinical care. Therefore, the number and timing of echocardiograms will vary between participants according to their clinical needs.

For participants who provide informed consent, copies of echocardiographic data will be collected from the six months before consent and for two years after consent. Clinical information relevant to cardiovascular health, including medications, electrocardiograms, blood test results, and other cardiac imaging where available, will also be collected from routinely generated health databases. These data will be collected over the same study period. There are no fixed study-specific clinical data collection visits or intervals; the frequency of available clinical information will depend on the participant's routine clinical care.

Echocardiographic data will be analysed for research purposes only using artificial intelligence and three-dimensional biophysical modelling techniques and compared with conventional echocardiographic measurements to evaluate their diagnostic and prognostic performance. Subsequent research results will not be used to guide or modify clinical decisions, treatment, or other aspects of patient care. No study-specific therapeutic intervention is administered.
Intervention code [1] 334845 0
Not applicable
Description of the comparator or control
Comparator: Conventional echocardiographic measurements.
Measurements derived using the novel artificial intelligence and three-dimensional biophysical modelling techniques will be compared with corresponding conventional echocardiographic measurements obtained from clinical echocardiography reports. Conventional measurements will be performed according to standard clinical protocols and recommendations. Measures of interest include cardiac chamber volumes, left ventricular dimensions and wall thickness, and indices of systolic function including ejection fraction, global longitudinal strain and myocardial work index. Agreement between the novel and conventional measurements will be assessed using paired statistical comparisons, Bland-Altman analysis, and intraclass correlation coefficients. The comparison is within participants; there is no separate control group and participants are not allocated to different study groups.
Control group
Active

Outcomes
Primary outcome [1] 346301 0
Agreement between automated artificial intelligence-based echocardiography measurements and conventional clinical echocardiographic measurements for left ventricular ejection fraction
Timepoint [1] 346301 0
At each clinically indicated echocardiogram available from six months before consent until two years after consent., as frequent as every 3 months.
Primary outcome [2] 346650 0
Agreement between automated artificial intelligence-based echocardiography measurements and conventional clinical echocardiographic measurements for left ventricular diastolic function classification.
Timepoint [2] 346650 0
At each clinically indicated echocardiogram available from six months before consent until two years after consent., as frequent as every 3 months.
Secondary outcome [1] 465354 0
Feasibility of automated three-dimensional echocardiography for routine clinical reporting.
Timepoint [1] 465354 0
At each clinically indicated echocardiogram available from six months before consent until two years after consent., as frequent as every 3 months.

Eligibility
Key inclusion criteria
Adults (at least 18 years of age) able to provide informed consent who are scheduled for, or have recently undergone, a routine clinically indicated echocardiogram.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Unable to provide informed consent.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
9/04/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
160
Final
Recruitment outside Australia
Country [1] 28368 0
New Zealand
State/province [1] 28368 0

Funding & Sponsors
Funding source category [1] 322520 0
Government body
Name [1] 322520 0
Health Research Council of New Zealand
Country [1] 322520 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 325441 0
None
Name [1] 325441 0
Address [1] 325441 0
Country [1] 325441 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321004 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 321004 0
Ethics committee country [1] 321004 0
New Zealand
Date submitted for ethics approval [1] 321004 0
13/11/2024
Approval date [1] 321004 0
14/02/2025
Ethics approval number [1] 321004 0

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

Contacts
Principal investigator
Name 152334 0
A/Prof Nicola Edwards
Address 152334 0
University of Auckland, Faculty of Medical & Health Sciences Building 507, 28 Park Avenue, Grafton, Auckland 1023
Country 152334 0
New Zealand
Phone 152334 0
+64 2108859250
Fax 152334 0
Email 152334 0
[email protected]
Contact person for public queries
Name 152335 0
Debbie Zhao
Address 152335 0
Auckland Bioengineering Institute, 70 Symonds Street, Grafton, Auckland 1010
Country 152335 0
New Zealand
Phone 152335 0
+64 273051834
Fax 152335 0
Email 152335 0
[email protected]
Contact person for scientific queries
Name 152336 0
Debbie Zhao
Address 152336 0
Auckland Bioengineering Institute, 70 Symonds Street, Grafton, Auckland 1010
Country 152336 0
New Zealand
Phone 152336 0
+64 273051834
Fax 152336 0
Email 152336 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 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?
• Studies exploring new research questions
• Studies testing whether findings can be repeated or confirmed
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?
• Data repository: Cardiac Atlas Project (https://www.cardiacatlas.org/)

Are there extra considerations when requesting access to individual participant data?
Yes: Institutional policies on data sharing



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.