TRICORDER

  • Research type

    Research Study

  • Full title

    Triple Cardiovascular Disease Detection with Artificial Intelligence-enabled Stethoscope

  • IRAS ID

    321117

  • Contact name

    Nicholas Peters

  • Contact email

    n.peters@imperial.ac.uk

  • Clinicaltrials.gov Identifier

    NCT05987670

  • Duration of Study in the UK

    1 years, 11 months, 28 days

  • Research summary

    --Background--
    Heart failure (HF) means the heart cannot pump blood effectively. It is deadlier than most cancers, increasingly common and consumes 4% of the NHS budget. Early diagnosis maximises the benefits of treatments, improving symptoms, quality of life and survival. Unacceptably, 80% of patients are diagnosed with HF late, following an emergency hospital admission, and are likely to die prematurely – with substantial NHS cost. The remaining 20% – suspected of having HF by their GP – go through a long and rarely completed pathway to diagnosis. GPs have no accurate, easy-to-use tools to quickly check for HF. In our study of over 1000 NHS patients (The Lancet Digital Health, 2022), we demonstrated that a ‘smart stethoscope’ (Eko DUO), that fits easily into the GP routine of examining a patient, can detect HF with 92% accuracy (regardless of age, gender or ethnicity). Eko DUO records signals from the heart’s electrical activity and heart sounds, by simple placement on the patient’s chest. After only 15 seconds, Eko DUO can detect HF, having analysed these signals with in-built artificial intelligence (AI). Eko DUO has full regulatory approval for direct clinical use.

    --TRICORDER Study--
    TRICORDER is a collaboration between The NHS North West London Integrated Care System, Betsi Cadwaladr University Health Board and Imperial College London for public health benefit. We will determine if providing GPs with Eko DUO increases early detection of HF for patients, and if this saves money for the NHS, by recruiting GP practices across North West London (NWL) and North Wales (NWA) to a cluster randomised controlled trial – in which half will be selected at random to receive the Eko DUO, and half will not. In practices with access to Eko DUO, we will measure if this is associated with (1) increased detection of HF, (2) reduced diagnosis through emergency hospital admission, and (3) reduced NHS costs. The Eko DUO is a fully UKCA/CE marked device being used within its intended purpose and commissioned for use by the local NHS organisations involved.

  • REC name

    London - Fulham Research Ethics Committee

  • REC reference

    23/LO/0051

  • Date of REC Opinion

    20 Jan 2023

  • REC opinion

    Favourable Opinion