Prospective Evaluation of AI-ECG for SHD Detection

Conditions studied

Valvular Heart Disease Stenosis and Regurgitation (Diagnosis), Pulmonary Hypertension (Diagnosis), Heart Failure With Reduced Ejection Fraction (HFrEF; Diagnosis), Heart Failure With Preserved Ejection Fraction (HFpEF; Diagnosis)

About this study

AI-ECG-SHD is a multicentre prospective observational diagnostic accuracy study evaluating artificial intelligence-enhanced electrocardiography (AI-ECG) for the detection of structural heart disease in adults undergoing clinically indicated transthoracic echocardiography (TTE). Participants undergo standard 12-lead ECG acquisition together with ECG recordings obtained using portable or wearable single-, 3-, and 6-lead devices. Established AI-ECG models will be evaluated for the detection of heart failure, pulmonary hypertension and valvular heart disease using TTE as the clinical reference standard, with performance compared across ECG acquisition modalities within the same prospective cohort. AI-ECG predictions are generated offline and are not provided to treating clinicians or used to alter clinical care. The study will also compare AI-ECG performance with N-terminal pro-B-type natriuretic peptide (NT-proBNP) and evaluate the diagnostic performance of a combined AI-ECG and NT-proBNP approach. The study aims to recruit 590 participants across six NHS hospital sites. A prespecified subgroup of 203 participants will undergo dedicated venous blood sampling for NT-proBNP; eligible same-day NT-proBNP measurements obtained as part of routine clinical care will also be included where available.

Interventions

• Other: Traditional 12-lead Electrocardiogram — A study-specific standard 12-lead ECG recording will be obtained with the participant in a semi-reclined position. A 10-second ECG will be acquired and pseudonymised for subsequent offline AI-ECG analysis. AI-ECG outputs will not be used to inform or alter clinical care.
• Other: Apple Watch Series 4 Single-lead Electrocardiogram — A 30-second single-lead ECG will be recorded using an Apple Watch Series 4. The watch will be worn on the participant's left wrist and the participant will place their right index finger on the Digital Crown during recording. The ECG will be used for subsequent offline AI-ECG analysis and will not inform clinical care.
• Other: Eko Core 500 Digital Stethoscope 3-lead Electrocardiogram — A 30-second 3-lead ECG will be recorded using the Eko CORE 500 digital stethoscope with the participant seated. The device will be positioned over the upper left parasternal region. The ECG will be used for subsequent offline AI-ECG analysis and will not inform clinical care.
• Other: AliveCor KardiaMobile Single- and 6-lead Electrocardiogram — Two 30-second ECG recordings will be obtained using the AliveCor KardiaMobile 6L device: a single-lead recording with the participant's thumbs placed on the upper electrodes, followed by a 6-lead recording with the thumbs on the upper electrodes and the lower electrode in contact with the left knee or ankle. Recordings will be used for subsequent offline AI-ECG analysis and will not inform clinical care.
• Other: Phlebotomy for N-terminal pro-B-type natriuretic peptide — A single 10 mL venous blood sample will be collected from the prespecified subgroup of 203 participants for measurement of serum NT-proBNP. Samples will be analysed by the relevant hospital clinical biochemistry laboratory and disposed of after testing. Eligible same-day NT-proBNP measurements obtained as part of routine NHS care may also be included without an additional blood sample. NT-proBNP results collected for the study will not be used to alter clinical care.

Primary outcomes

• AI-ECG model classification performance for detection of structural heart disease (Single study visit on the day of clinically indicated TTE (approximately 30-35 minutes); diagnostic performance calculated following completion of data collection.)