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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: t
View:

• Patients aged 18-90 years

• No prior formal diagnosis of HF (including systolic and diastolic dysfunction), PH, or VHD

• Ability to provide informed consent

Locations
Other Locations
United Kingdom
Chelsea and Westminster 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
This cohort of patients will be attending for inpatient and outpatient transthoracic echocardiograms (TTEs) as part of their routine clinical care, having been referred by clinicians for various standard TTE indications, including investigation of symptoms such as breathlessness due to possible heart failure (HF), and screening for suspected valvular heart disease (VHD) and/or pulmonary hypertension (PH). These patients will have had no prior formal diagnosis of HF, VHD, and/or PH.
N-terminal pro B-type natriuretic peptide subgroup
A subgroup of 203 patients, out of the total 590 patiets in the Echocardiography cohort, will be randomised to undergo blood tests and collection of serum N-terminal pro B-type natriuretic peptide (NT-proBNP).
Sponsors
Leads: Imperial College London

This content was sourced from clinicaltrials.gov