Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001032347
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
29/06/2026
Date registered
Help: Date registered
21/08/2026
Date last updated
Help: Date last updated
21/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
21/08/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Advanced Electrocardiogram (A-ECG) software triage to optimise the detection of structural heart disease in adults undergoing routine clinical electrocardiograms (ECGs)
Scientific title
Advanced electrocardiogram (A-ECG) augmented triage to optimise the diagnostic yield of moderate-to-severe left ventricular systolic dysfunction (LVSD) and structural heart disease (SHD) on echocardiography in adults undergoing routine 12-lead electrocardiograms (ECGs)
Additional trial identifiers [1] 317724 0
WAI20549
Additional trial identifiers [2] 317726 0
WAI20277
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Structural Heart Disease (SHD) 342614 0
Left Ventricular Systolic Dysfunction (LVSD 342847 0
Condition category
Condition code
Cardiovascular 338766 338766 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Arm 1 (Intervention): Advanced ECG (A-ECG) software triage (10-second turnaround for results). All ECGs will be collected in the usual manner for obtaining a 12-lead ECG, and no additional time or preparation is required by clinical staff. A-ECG risk output is integrated into existing clinical ECG workflows to flag high risk for Left Ventricular Systolic Dysfunction (LVSD) and Structural Heart Disease (SHD). The A-ECG result is visible in Testsafe electronic records. A positive flag generates a standardised recommendation in the ECG report for clinicians to consider prioritised or targeted echocardiography. Audit logs of whether A-ECG reports have been viewed will be maintained in the EHR, as with all laboratory results. At initiation, this is a single-site study (Te Whatu Ora - Waitemata, of which there are two hospitals, North Shore and Waitakere, though they will be considered as one aggregate hospital system). Further hospital sites may become available over the course of the study for a crossover design. A-ECG will be used in the hospitals for 36 months. A-ECG will be applied to the first, index ECG at admission as well as subsequent ECGs for that individual based on their randomised category status.
Intervention code [1] 334565 0
Early detection / Screening
Intervention code [2] 334742 0
Diagnosis / Prognosis
Description of the comparator or control
Interpretation of the conventional ECG result will be performed by the attending clinician, e.g., an ED doctor, a general medicine doctor, or an anaesthetist. ECG results are accessible through Testsafe, alongside the Electronic Health Record (EHR). Usual clinical referral processes are undertaken as auditable electronic referrals for echocardiography, other cardiac imaging or laboratory investigations, e.g. NTproBNP. Standard ECG interpretation and usual clinical referral processes, with no A-ECG risk flag provided to clinicians. The control group is prospective and will include those randomly allocated not to receive A-ECG analysis during the 36-month intervention period.
Control group
Active

Outcomes
Primary outcome [1] 345961 0
Diagnostic yield of moderate-to-severe left ventricular systolic dysfunction (LVSD)
Timepoint [1] 345961 0
Within 90 days of the index ECG
Primary outcome [2] 346199 0
Diagnostic yield of structural heart disease (SHD
Timepoint [2] 346199 0
Within 90 days of the index ECG
Secondary outcome [1] 463953 0
Time to echocardiography
Timepoint [1] 463953 0
Within 90 days of the index ECG
Secondary outcome [2] 463954 0
Cost-effectiveness and cost per true positive detected as a composite secondary outcome
Timepoint [2] 463954 0
At the completion of the 36-month trial period
Secondary outcome [3] 463955 0
Composite outcome: Equity of impact and access across ethnicities, i.e., comparison of time to echocardiography by ethnicity, sex, age, and NZ deprivation quintile
Timepoint [3] 463955 0
At completion of the 36-month trial period
Secondary outcome [4] 464962 0
Echocardiography utilisation
Timepoint [4] 464962 0
Within 90 days of the index ECG
Secondary outcome [5] 464963 0
Number of targeted echocardiograms
Timepoint [5] 464963 0
Within 90 days of the index ECG

Eligibility
Key inclusion criteria
Consecutive adult patients undergoing routine or clinically indicated 12-lead ECGs captured by hospital systems across emergency, inpatient, and outpatient services.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
ECGs with insufficient quality for analysis.
Duplicate ECGs for the same patient within a pre-specified window (e.g., 30–90 days).
Specific paced rhythms where the algorithm is not validated.

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)
Allocation is not concealed. This is a pragmatic, hospital-wide cluster crossover trial where entire hospital sites cross over from control to intervention at scheduled times. We will assess outcomes pre- and post-intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random sequence to determine the order of hospital site crossover. This is determined randomly based on the number of hospitals involved, in a 1:1 paired simultaneous fashion.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This is a pragmatic, hospital-wide cluster crossover trial where entire hospital sites cross over from control to intervention at scheduled times
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size is based on detecting a 10% absolute increase in diagnostic yield (using a benchmark from the EAGLE trial https://www.nature.com/articles/s41591-021-01335-4). To detect this difference with 80% power and a two-sided alpha of 0.05, approximately 1,200 patients per group are required. The study anticipates enrolling approximately 5,480 patients (via routine echocardiogram referrals) across two hospital sites over the 12-month trial period, providing adequate statistical power.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2026
Actual
Date of last participant enrolment
Anticipated
31/10/2029
Actual
Date of last data collection
Anticipated
31/01/2030
Actual
Sample size
Target
5480
Accrual to date
Final
Recruitment outside Australia
Country [1] 28262 0
New Zealand
State/province [1] 28262 0

Funding & Sponsors
Funding source category [1] 322269 0
Government body
Name [1] 322269 0
Health New Zealand - Te Whatu Ora - Waitemata
Country [1] 322269 0
New Zealand
Primary sponsor type
Government body
Name
Health New Zealand - Te Whatu Ora - Waitemata
Address
Country
New Zealand
Secondary sponsor category [1] 325183 0
None
Name [1] 325183 0
Address [1] 325183 0
Country [1] 325183 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320786 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 320786 0
Ethics committee country [1] 320786 0
New Zealand
Date submitted for ethics approval [1] 320786 0
26/02/2026
Approval date [1] 320786 0
11/05/2026
Ethics approval number [1] 320786 0
2026 FULL 25129

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

Contacts
Principal investigator
Name 151622 0
Dr Patrick A Gladding
Address 151622 0
North Shore hospital Waiteamata, 124 Shakespeare Road, Takapuna, Auckland 0620, New Zealand
Country 151622 0
New Zealand
Phone 151622 0
+64 9 486 8900
Fax 151622 0
Email 151622 0
[email protected]
Contact person for public queries
Name 151623 0
Patrick A Gladding
Address 151623 0
North Shore hospital Waiteamata, 124 Shakespeare Road, Takapuna, Auckland 0620, New Zealand
Country 151623 0
New Zealand
Phone 151623 0
+64 9 486 8900
Fax 151623 0
Email 151623 0
[email protected]
Contact person for scientific queries
Name 151624 0
Patrick A Gladding
Address 151624 0
North Shore hospital Waiteamata, 124 Shakespeare Road, Takapuna, Auckland 0620, New Zealand
Country 151624 0
New Zealand
Phone 151624 0
+64 9 486 8900
Fax 151624 0
Email 151624 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Could result in reidentification



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.