NCT07057466 Prospective Evaluation of AI-ECG for SHD Detection
| NCT ID | NCT07057466 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Imperial College London |
| Condition | Valvular Heart Disease Stenosis and Regurgitation (Diagnosis) |
| Study Type | OBSERVATIONAL |
| Enrollment | 590 participants |
| Start Date | 2025-11-04 |
| Primary Completion | 2027-05-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 590 participants in total. It began in 2025-11-04 with a primary completion date of 2027-05-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria * Patients awaiting a transthoracic echocardiogram (TTE) based on clinical grounds as part of their standard care * Age 18-90 years * Able to provide informed consent Exclusion Criteria * Severe arrhythmia or unstable cardiovascular disease * Known severe structural heart disease, defined as any of the following: severe left ventricular systolic dysfunction (LVEF ≤35%); severe valvular heart disease according to current British Society of Echocardiography criteria; high echocardiographic probability of pulmonary hypertension according to current British Society of Echocardiography criteria; or previous structural cardiac intervention, including valve repair, valve replacement/implantation, or surgical repair of a cardiac chamber or congenital structural abnormality * Cardiac implantable electronic device in situ, including a permanent pacemaker or implantable cardioverter defibrillator * Current or recent involvement in another research study
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07057466 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Valvular Heart Disease Stenosis and Regurgitation (Diagnosis). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07057466 currently recruiting?
Yes, NCT07057466 is actively recruiting participants. Contact the research team at a.el-medany24@imperial.ac.uk for enrollment information.
Where is the NCT07057466 trial being conducted?
This trial is being conducted at Bristol, United Kingdom, Bristol, United Kingdom, London, United Kingdom, London, United Kingdom and 2 additional locations.
Who is sponsoring the NCT07057466 clinical trial?
NCT07057466 is sponsored by Imperial College London. The trial plans to enroll 590 participants.