Prospective Evaluation of Artificial Intelligence-enhanced Electrocardiography for Detection of Structural Heart Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Imperial College London
- Enrollment
- 590
- Locations
- 5
- Primary Endpoint
- AI-ECG model classification performance for detection of structural heart disease (SHD)
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Intervention: Traditional 12-lead Electrocardiogram (Other)
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.
Intervention: Apple Watch Series 4 Single-lead Electrocardiogram (Other)
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.
Intervention: Eko Core 500 Digital Stethoscope 3-lead Electrocardiogram (Other)
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.
Intervention: AliveCor KardiaMobile Single- and 6-lead Electrocardiogram (Other)
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).
Intervention: Traditional 12-lead Electrocardiogram (Other)
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).
Intervention: Apple Watch Series 4 Single-lead Electrocardiogram (Other)
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).
Intervention: Eko Core 500 Digital Stethoscope 3-lead Electrocardiogram (Other)
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).
Intervention: AliveCor KardiaMobile Single- and 6-lead Electrocardiogram (Other)
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).
Intervention: Phlebotomy for N-terminal pro-B-type natriuretic peptide (Other)
Outcomes
Primary Outcomes
AI-ECG model classification performance for detection of structural heart disease (SHD)
Time Frame: From enrolment to end of patient's study visit (up to 1 hour)
AI-ECG model classification performance for HF, PH, and VHD, will be assessed for all ECG modalities (single-, 3-, 6-, and 12-lead ECGs) using the area under the receiver operating characteristic (AUROC; pre-defined threshold).
Secondary Outcomes
- Additional AI-ECG performance metrics for detection of SHD(From enrolment to end of patient's study visit (up to 1 hour))
- NT-proBNP performance metrics for detection of SHD(From enrolment to end of patient's study visit (up to 1 hour))
- Combined AI-ECG and NT-proBNP performance analysis for detection of SHD(From enrolment to end of patient's study visit (up to 1 hour))