NCT07057466Recruiting
Prospective Evaluation of AI-ECG for SHD Detection
Prospective Evaluation of Artificial Intelligence-enhanced Electrocardiography for Detection of Structural Heart Disease
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 590 (estimated)
- First submitted
- 26 Jun 2025
- Start date
- Nov 2025
- Primary completion date
- May 2027
- Lead sponsor
- Imperial College London
- NCT number
- NCT07057466
What you commit to
- Study type: Observational
- Planned participants: 590
- From Nov 2025 to the primary completion date, May 2027
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe arrhythmia or unstable cardiovascular disease
- Cardiac implantable electronic device in situ, including a permanent pacemaker or implantable cardioverter defibrillator
Lab values
- 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
Other
- Current or recent involvement in another research study
Who the study is looking for
- 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
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bristol Royal Infirmary Coordinator of this site? Confirm its status | Bristol | United Kingdom | Recruiting |
| Southmead Hospital Coordinator of this site? Confirm its status | Bristol | United Kingdom | Recruiting |
| West Middlesex University Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Hammersmith Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Chelsea And Westminster Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| St Mary's Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.