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Triple Cardiovascular Disease Detection With an Artificial Intelligence-enabled Stethoscope (TRICORDER)

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ClinicalTrials.gov Identifier: NCT05987670
Recruitment Status : Not yet recruiting
First Posted : August 14, 2023
Last Update Posted : August 22, 2023
Sponsor:
Collaborator:
Imperial College Health Partners
Information provided by (Responsible Party):
Imperial College London

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Heart Failure Heart Valve Diseases Atrial Fibrillation Heart Murmurs Congestive Heart Failure Heart Failure With Reduced Ejection Fraction Device: AI-stethoscope Not Applicable

Detailed Description:
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 and North Wales (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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open label cluster randomised controlled trial
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Triple Cardiovascular Disease Detection With an Artificial Intelligence-enabled Stethoscope
Estimated Study Start Date : October 1, 2023
Estimated Primary Completion Date : April 1, 2025
Estimated Study Completion Date : October 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention

Receive 3-6 AI-stethoscopes (Eko DUO, Eko Health Inc, CA, USA) including artificial intelligence software for detection of:

  1. Reduced left ventricular ejection fraction <40%
  2. Atrial fibrillation
  3. Cardiac murmurs
 Device: AI-stethoscope

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

  1. Delivery and setup
  2. Smartphone app installation and login
  3. Pairing of all clinician smartphones with all AI-stethoscopes in the same practice
  4. 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
No Intervention: Control
Usual care


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05987670


Contacts
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Contact: Mihir Kelshiker, MD 020 7589 5111 mihir.kelshiker10@imperial.ac.uk

Sponsors and Collaborators
Imperial College London
Imperial College Health Partners
Investigators
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Principal Investigator: Nicholas S Peters, MD Imperial College London
More Information
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Publications:

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT05987670    
Other Study ID Numbers: 22HH8045
First Posted: August 14, 2023    Key Record Dates
Last Update Posted: August 22, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Imperial College London:
cluster randomized controlled trial
artificial intelligence
digital health
cardiology
primary care
Additional relevant MeSH terms:
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Heart Failure
Atrial Fibrillation
Cardiovascular Diseases
Heart Valve Diseases
 Heart Murmurs
Heart Diseases
Arrhythmias, Cardiac
Pathologic Processes