Advanced Electrocardiogram (A-ECG) software triage to optimise the detection of structural heart disease in adults undergoing routine clinical electrocardiograms (ECGs)

Authors
Category Primary study
Registry of TrialsAustralian New Zealand Clinical Trials Registry
Year 2026
INTERVENTION: 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, inde XECG at admission as well as subsequent ECGs for that individual based on their randomised category status. CONDITION: Cardiovascular ‐ Other cardiovascular diseases Structural Heart Disease (SHD);Left Ventricular Systolic Dysfunction (LVSD; ; Structural Heart Disease (SHD) ; Left Ventricular Systolic Dysfunction (LVSD PRIMARY OUTCOME: Diagnostic yield of moderate‐to‐severe left ventricular systolic dysfunction (LVSD)[Proportion of echocardiograms confirming the diagnosis on ICD10 clinical criteria, NTproBNP and echocardiography Within 90 days of the index ECG] Diagnostic yield of structural heart disease (SHD[Proportion of echocardiograms confirming the diagnosis Within 90 days of the index ECG] SECONDARY OUTCOME: Composite outcome: Equity of impact and access across ethnicities, i.e., comparison of time to echocardiography by ethnicity, sex, age, and NZ deprivation quintile[Composite outcome: Stratified effectiveness and diagnostic yield analysed by ethnicity (including Maori and Pacific), sex, age, and NZ deprivation quintile At completion of the 36‐month trial period] Cost‐effectiveness and cost per true positive detected as a composite secondary outcome[Economic evaluation comparing intervention and control groups from a health system perspective using quality‐adjusted life years (QALYS) At the completion of the 36‐month trial period] Echocardiography utilisation[Number of echocardiograms that were normal, compared to those showing the predicted pathology, extracted from electronic health records. Within 90 days of the inde XECG] Number of targeted echocardiograms[Audit of echocardiography triaging Within 90 days of the inde XECG ; ] Time to echocardiography[Time in days from inde XECG to actual echocardiogram, based on audit trails from A‐ECG result and e‐referrals for echocardiography Within 90 days of the inde XECG] INCLUSION CRITERIA: Consecutive adult patients undergoing routine or clinically indicated 12‐lead ECGs captured by hospital systems across emergency, inpatient, and outpatient services.
Epistemonikos ID: d322c90c4d7195e16e244f7de1ad6323d513bdb4
First added on: Oct 08, 2026