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Prospective Evaluation of AI-ECG for SHD Detection

Prospective Evaluation of AI-ECG for SHD Detection

Recruiting
18-90 years
All
Phase N/A

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Overview

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

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

Study details
    Valvular Heart Disease Stenosis and Regurgitation (Diagnosis)
    Pulmonary Hypertension (Diagnosis)
    Heart Failure With Reduced Ejection Fraction (HFrEF; Diagnosis)
    Heart Failure With Preserved Ejection Fraction (HFpEF; Diagnosis)

NCT07057466

Imperial College London

1 February 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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