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Prospective Evaluation of Artificial Intelligence-enhanced Electrocardiography for Detection of Structural Heart Disease

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
Bristol Royal Infirmary
RECRUITING
Bristol
Southmead Hospital
RECRUITING
Bristol
Chelsea and Westminster Hospital
RECRUITING
London
Hammersmith Hospital
RECRUITING
London
St Mary's Hospital
RECRUITING
London
West Middlesex University Hospital
RECRUITING
London
Contact Information
Primary
Ahmed YM El-Medany, MBChB, MRCP, MSc, FHEA
a.el-medany24@imperial.ac.uk
+44 02075943614
Time Frame
Start Date: 2025-11-04
Estimated Completion Date: 2027-08-02
Participants
Target number of participants: 590
Treatments
Echocardiography cohort
Adult inpatients and outpatients undergoing transthoracic echocardiography (TTE) as part of routine clinical care will be recruited prospectively. Participants will undergo study-specific 12-lead ECG acquisition and portable or wearable single-, 3-, and 6-lead ECG recordings. Patients with known severe structural heart disease are excluded, while patients with previously diagnosed structural abnormalities that do not meet the prespecified severe structural heart disease exclusion criteria may remain eligible. AI-ECG predictions will be generated offline and will not inform clinical care.
N-terminal pro B-type natriuretic peptide subgroup
A prespecified subgroup of 203 participants from the overall 590-participant cohort will be selected by stratified randomisation to undergo dedicated venepuncture for measurement of serum NT-proBNP. In addition, eligible same-day NT-proBNP measurements obtained as part of routine clinical care will be included in the NT-proBNP analysis where available. The final NT-proBNP analysis population may therefore exceed the dedicated 203-participant phlebotomy subgroup.
Sponsors
Leads: Imperial College London

This content was sourced from clinicaltrials.gov

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