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Prospective Evaluation of AI-ECG for SHD Detection

Recruitingn/aAges 18 Years - 90 YearsAllImperial College London
NCT07057466 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 natr

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📋 Eligibility rules (as published)
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
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What it tests

  • Traditional 12-lead Electrocardiogram
  • Apple Watch Series 4 Single-lead Electrocardiogram
  • Eko Core 500 Digital Stethoscope 3-lead Electrocardiogram
  • AliveCor KardiaMobile Single- and 6-lead Electrocardiogram
  • Phlebotomy for N-terminal pro-B-type natriuretic peptide
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Where

6 sites
Bristol Royal Infirmary
Bristol, United Kingdom
Southmead Hospital
Bristol, United Kingdom
Chelsea and Westminster Hospital
London, United Kingdom
Hammersmith Hospital
London, United Kingdom
St Mary's Hospital
London, United Kingdom
West Middlesex University Hospital
London, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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