Prospective Evaluation of AI-ECG for SHD Detection
Recruiting · NCT07057466 · Observational (researchers observe without assigning treatment) · Lead sponsor: Imperial College London
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This study aims to improve the early detection of undiagnosed heart disease, which causes serious health issues, hospital admissions, and high healthcare costs. Researchers are exploring how artificial intelligence (AI) can analyse routine heart tests, called electrocardiograms (ECGs), to detect heart problems. These tests can be done using both traditional ECG machines and portable, wearable devices like smartwatches, making it easier for people to monitor their heart health at home. While AI has shown promise using past data, this study will involve the collection of ECG data and subsequent testing of its accuracy in real-world settings to ensure it works well for both doctors and patients. The goal is to see if AI can identify conditions like heart muscle weakness, valve issues, and high lung pressure from the ECG data of patients. The researchers will also compare AI's detections with other blood tests commonly used to diagnose heart disease. The AI models that will be used are being tested for research and validation purposes only. They will not be used for clinical decision-making or providing information to influence diagnosis, treatment, or patient care during the study. The AI outputs are not shared with clinicians and will have no impact on the care pathway. This research will demonstrate if AI-powered ECG analysis - whether from traditional or portable devices - can provide a low-cost, non-invasive way to detect heart disease early and improve health assessments.
Who can take part
Inclusion criteria
- Patients aged 18-90 years
- No prior formal diagnosis of HF (including systolic and diastolic dysfunction), PH, or VHD
- Ability to provide informed consent
Exclusion criteria
- Severe arrhythmia or unstable cardiovascular disease
- Prior formal diagnosis of HF (including systolic and diastolic dysfunction), PH, or VHD
- Cardiac implantable electronic device in-situ, including a permanent pacemaker or implantable cardioverter defibrillator
- Involvement in current research or recent involvement in any research prior to recruitment
Where it is running
10 locations listed.
- Southmead Hospital - 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
- 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