None listed
Conditions
Brief summary
Cardiovascular disease is a leading cause of illness and death, and delays in diagnostic scans like echocardiograms can worsen patient outcomes. This study aims to find out if using an advanced software tool (A-ECG) can better identify patients at high risk of structural heart disease from their routine electrocardiograms (ECGs) compared to standard care. We expect that automatically flagging high-risk patients for clinicians will increase the rate of early detection and streamline hospital waitlists. The study is a hospital-wide crossover trial where entire hospital sites will switch between using the A-ECG software (intervention) and standard clinical care (control). We will evaluate if this software increases the successful diagnosis of heart disease within 90 days, while also measuring the impact on wait times, hospital costs, and equitable access to care.
Interventions
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
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.
Sponsors
Health New Zealand - Te Whatu Ora - Waitemata
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Consecutive adult patients undergoing routine or clinically indicated 12-lead ECGs captured by hospital systems across emergency, inpatient, and outpatient services.
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.
Outcome results
None listed