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Active, Not Recruiting

NCT Number: NCT05987670

Triple Cardiovascular Disease Detection With an Artificial Intelligence-enabled Stethoscope

Heart failure (HF) is a condition in which the heart cannot pump blood adequately. It is increasingly common, consumes 4% of the UK National Health Service (NHS) budget and is deadlier than most cancers. Early diagnosis and treatment of HF improves quality of life and survival. Unacceptably, 80% of patients have their HF diagnosed only when very unwell, requiring an emergency hospital admission, with worse survival and higher treatment costs to the NHS. This is largely because General Practitioners (GPs) have no easy-to-use tools to check for suspected HF, with patients having to rely on a long and rarely completed diagnostic pathway involving blood tests and hospital assessment.

The investigators have previously demonstrated that an artificial intelligence-enabled stethoscope (AI-stethoscope) can detect HF in 15 seconds with 92% accuracy (regardless of age, gender or ethnicity) - even before patients develop symptoms. While the GP uses the stethoscope, it records the heart sounds and electrical activity, and uses inbuilt artificial intelligence to detect HF.

The goal of this clinical trial is to determine the clinical and cost-effectiveness of providing primary care teams with the AI-stethoscope for the detection of heart failure. The main questions it aims to answer are if provision of the AI-stethoscope:

1. Increases overall detection of heart failure 2. Reduces the proportion of patients being diagnosed with heart failure following an emergency hospital admission 3. Reduces healthcare system costs

200 primary care practices across North West London and North Wales, UK, will be recruited to a cluster randomised controlled trial, meaning half of the primary care practices will be randomly assigned to have AI-stethoscopes for use in direct clinical care, and half will not. Researchers will compare clinical and cost outcomes between the groups.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NHS North West London Integrated Care System

London, United Kingdom

About this study

Triple Cardiovascular Disease Detection with Artificial Intelligence-enabled Stethoscope (TRICORDER) is an open label, cluster randomised controlled trial. The aim is to determine whether use of an artificial intelligence-enabled stethoscope (AI-stethoscope) in UK Primary Care improves community-based detection of heart failure (HF), compared with usual care. 200 primary care practices in North West London (UK) will be randomised to receive the AI-stethoscope (intervention arm) or continue with usual care (control arm). The intervention arm will use the AI-stethoscope in routine clinical practice. Outcomes will be measured using pooled primary and secondary care clinical and cost-data, as well as clinician questionnaires.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary care practices that care for adult patients and have the ability to request natriuretic peptide blood testing
  • Primary care practices within the NIHR North West London Clinical Research Network or Betsi Cadwaladr University Health Board.

Exclusion criteria

  • Poor WiFi and/or mobile data connectivity within primary care consulting rooms
  • No face-to-face patient consultations

Treatment and study plan

AI-stethoscope

Device

Clinicians at practices in the intervention arm will be provided with one session of in-person training in use of the AI-stethoscope within 2 weeks of randomisation, including

  • Delivery and setup
  • Smartphone app installation and login
  • Pairing of all clinician smartphones with all AI-stethoscopes in the same practice
  • Demo of patient examination The AI-stethoscope will be used within its CE/UKCA-marked intended purpose. The clinical guidelines for use have been agreed by the NHS North West London Integrated Care System and Betsi Cadwaladr University Health Board Cardiovascular Executive Groups. Patients will be examined with the AI-stethoscope in accordance with these guidelines, and/or where stethoscope examination is deemed clinically appropriate. Patients will provide verbal consent for examination with the AI-stethoscope as per any physical examination performed by healthcare professionals for direct care, in accordance with UK law and General Medical Council guidelines.

Other names: Eko DUO, Eko Core 500, Eko EAS

Primary outcomes

  1. Incidence of heart failure (co-primary)

    Time frame: 24 months

    Difference in incidence of coded new diagnoses of heart failure (HF)

  2. Ratio of route to diagnosis of heart failure (co-primary) between emergency and community-based pathways

    Time frame: 24 months

    Difference in ratio of the incidence of coded diagnoses of HF via hospital admission-based versus community-based pathways.

Secondary outcomes

  1. Incidence of atrial fibrillation

    Time frame: 24 months

    New coded diagnoses of atrial fibrillation (AF)

  2. Incidence of valvular heart disease

    Time frame: 24 months

    New coded diagnoses of valvular heart disease (VHD)

  3. Cost-consequence (AF)

    Time frame: 24 months

    Cost-consequence analysis (form of health economic evaluation) for diagnosis of atrial fibrillation, stratified by route to diagnosis. Presented in pounds sterling.

  4. Cost-consequence (HFrEF)

    Time frame: 24 months

    Cost-consequence analysis (form of health economic evaluation) for diagnosis of HFrEF, stratified by route to diagnosis. Presented in pounds sterling.

  5. Cost-consequence (VHD)

    Time frame: 24 months

    Cost-consequence analysis (form of health economic evaluation) for diagnosis of VHD, stratified by route to diagnosis. Presented in pounds sterling.

  6. Health service utilisation

    Time frame: 24 months

    Health service utilisation for diagnostics e.g. rates of request for echocardiography, electrocardiography, primary care appointments. Collected from NHS organisation business intelligence repositories and UK Trusted Research Environments.

  7. Proportion of patients prescribed guideline-directed medical therapy

    Time frame: 24 months

    Proportion of patients prescribedguideline-directed medical therapy (HF, AF, VHD)

  8. Device therapy

    Time frame: 24 months

    New implantation of cardiac resynchronisation therapy (CRT) and/or implantable cardioverter-defibrillator (ICD)

  9. Uptake and utilisation

    Time frame: 24 months

    Differential rates of uptake and utilisation of AI-stethoscope in primary care

  10. Determinants of uptake and utilisation

    Time frame: 24 months

    Determinants of utilisation of AI-stethoscope in primary care (clinician questionnaires)

  11. Patient quality of life

    Time frame: 24 months

    Healthy Days at Home (patient-level analysis)

Other outcomes

  1. Sensitivity analysis

    Time frame: 24 months

    Patient-level sensitivity analyses will be performed for patients with abnormal Eko DUO predictions for HF, to identify direct associations between AI-stethoscope predictions and specific diagnostic codes for HF, AF and VHD

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Imperial College Health Partners

Registry information

Acronym: TRICORDER

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 14, 2023
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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