xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05987670</url>
    </required_header>
    <id_info>
      <org_study_id>22HH8045</org_study_id>
      <nct_id>NCT05987670</nct_id>
    </id_info>
    <brief_title>Triple Cardiovascular Disease Detection With an Artificial Intelligence-enabled Stethoscope</brief_title>
    <acronym>TRICORDER</acronym>
    <official_title>Triple Cardiovascular Disease Detection With an Artificial Intelligence-enabled Stethoscope</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Imperial College London</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Imperial College Health Partners</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Imperial College London</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Heart failure (HF) is a condition in which the heart cannot pump blood adequately. It is&#xD;
        increasingly common, consumes 4% of the UK National Health Service (NHS) budget and is&#xD;
        deadlier than most cancers. Early diagnosis and treatment of HF improves quality of life and&#xD;
        survival. Unacceptably, 80% of patients have their HF diagnosed only when very unwell,&#xD;
        requiring an emergency hospital admission, with worse survival and higher treatment costs to&#xD;
        the NHS. This is largely because General Practitioners (GPs) have no easy-to-use tools to&#xD;
        check for suspected HF, with patients having to rely on a long and rarely completed&#xD;
        diagnostic pathway involving blood tests and hospital assessment.&#xD;
  &#xD;
        The investigators have previously demonstrated that an artificial intelligence-enabled&#xD;
        stethoscope (AI-stethoscope) can detect HF in 15 seconds with 92% accuracy (regardless of&#xD;
        age, gender or ethnicity) - even before patients develop symptoms. While the GP uses the&#xD;
        stethoscope, it records the heart sounds and electrical activity, and uses inbuilt artificial&#xD;
        intelligence to detect HF.&#xD;
  &#xD;
        The goal of this clinical trial is to determine the clinical and cost-effectiveness of&#xD;
        providing primary care teams with the AI-stethoscope for the detection of heart failure. The&#xD;
        main questions it aims to answer are if provision of the AI-stethoscope:&#xD;
  &#xD;
          1. Increases overall detection of heart failure&#xD;
  &#xD;
          2. Reduces the proportion of patients being diagnosed with heart failure following an&#xD;
             emergency hospital admission&#xD;
  &#xD;
          3. Reduces healthcare system costs&#xD;
  &#xD;
        200 primary care practices across North West London and North Wales, UK, will be recruited to&#xD;
        a cluster randomised controlled trial, meaning half of the primary care practices will be&#xD;
        randomly assigned to have AI-stethoscopes for use in direct clinical care, and half will not.&#xD;
        Researchers will compare clinical and cost outcomes between the groups.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Triple Cardiovascular Disease Detection with Artificial Intelligence-enabled Stethoscope&#xD;
        (TRICORDER) is an open label, cluster randomised controlled trial. The aim is to determine&#xD;
        whether use of an artificial intelligence-enabled stethoscope (AI-stethoscope) in UK Primary&#xD;
        Care improves community-based detection of heart failure (HF), compared with usual care. 200&#xD;
        primary care practices in North West London and North Wales (UK) will be randomised to&#xD;
        receive the AI-stethoscope (intervention arm) or continue with usual care (control arm). The&#xD;
        intervention arm will use the AI-stethoscope in routine clinical practice. Outcomes will be&#xD;
        measured using pooled primary and secondary care clinical and cost-data, as well as clinician&#xD;
        questionnaires.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">April 1, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Open label cluster randomised controlled trial</intervention_model_description>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of heart failure (co-primary)</measure>
      <time_frame>24 months</time_frame>
      <description>Difference in incidence of coded new diagnoses of heart failure (HF)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Ratio of route to diagnosis of heart failure (co-primary) between emergency and community-based pathways</measure>
      <time_frame>24 months</time_frame>
      <description>Difference in ratio of the incidence of coded diagnoses of HF via hospital admission-based versus community-based pathways.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Incidence of atrial fibrillation</measure>
      <time_frame>24 months</time_frame>
      <description>New coded diagnoses of atrial fibrillation (AF)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of valvular heart disease</measure>
      <time_frame>24 months</time_frame>
      <description>New coded diagnoses of valvular heart disease (VHD)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cost-consequence (AF)</measure>
      <time_frame>24 months</time_frame>
      <description>Cost-consequence analysis (form of health economic evaluation) for diagnosis of atrial fibrillation, stratified by route to diagnosis. Presented in pounds sterling.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cost-consequence (HFrEF)</measure>
      <time_frame>24 months</time_frame>
      <description>Cost-consequence analysis (form of health economic evaluation) for diagnosis of HFrEF, stratified by route to diagnosis. Presented in pounds sterling.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cost-consequence (VHD)</measure>
      <time_frame>24 months</time_frame>
      <description>Cost-consequence analysis (form of health economic evaluation) for diagnosis of VHD, stratified by route to diagnosis. Presented in pounds sterling.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health service utilisation</measure>
      <time_frame>24 months</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients prescribed guideline-directed medical therapy</measure>
      <time_frame>24 months</time_frame>
      <description>Proportion of patients prescribedguideline-directed medical therapy (HF, AF, VHD)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Device therapy</measure>
      <time_frame>24 months</time_frame>
      <description>New implantation of cardiac resynchronisation therapy (CRT) and/or implantable cardioverter-defibrillator (ICD)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Uptake and utilisation</measure>
      <time_frame>24 months</time_frame>
      <description>Differential rates of uptake and utilisation of AI-stethoscope in primary care</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Determinants of uptake and utilisation</measure>
      <time_frame>24 months</time_frame>
      <description>Determinants of utilisation of AI-stethoscope in primary care (clinician questionnaires)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient quality of life</measure>
      <time_frame>24 months</time_frame>
      <description>Healthy Days at Home (patient-level analysis)</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Sensitivity analysis</measure>
      <time_frame>24 months</time_frame>
      <description>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</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Heart Failure</condition>
    <condition>Heart Valve Diseases</condition>
    <condition>Atrial Fibrillation</condition>
    <condition>Heart Murmurs</condition>
    <condition>Congestive Heart Failure</condition>
    <condition>Heart Failure With Reduced Ejection Fraction</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Receive 3-6 AI-stethoscopes (Eko DUO, Eko Health Inc, CA, USA) including artificial intelligence software for detection of:&#xD;
  Reduced left ventricular ejection fraction &lt;40%&#xD;
  Atrial fibrillation&#xD;
  Cardiac murmurs</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Usual care</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>AI-stethoscope</intervention_name>
      <description>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&#xD;
  Delivery and setup&#xD;
  Smartphone app installation and login&#xD;
  Pairing of all clinician smartphones with all AI-stethoscopes in the same practice&#xD;
  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.</description>
      <arm_group_label>Intervention</arm_group_label>
      <other_name>Eko DUO</other_name>
      <other_name>Eko Core 500</other_name>
      <other_name>Eko EAS</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Primary care practices that care for adult patients and have the ability to request&#xD;
               natriuretic peptide blood testing&#xD;
  &#xD;
            -  Primary care practices within the NIHR North West London Clinical Research Network or&#xD;
               Betsi Cadwaladr University Health Board.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Poor WiFi and/or mobile data connectivity within primary care consulting rooms&#xD;
  &#xD;
            -  No face-to-face patient consultations&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Nicholas S Peters, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Imperial College London</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mihir Kelshiker, MD</last_name>
      <phone>020 7589 5111</phone>
      <email>mihir.kelshiker10@imperial.ac.uk</email>
    </overall_contact>
    <reference>
      <citation>Bachtiger P, Petri CF, Scott FE, Ri Park S, Kelshiker MA, Sahemey HK, Dumea B, Alquero R, Padam PS, Hatrick IR, Ali A, Ribeiro M, Cheung WS, Bual N, Rana B, Shun-Shin M, Kramer DB, Fragoyannis A, Keene D, Plymen CM, Peters NS. Point-of-care screening for heart failure with reduced ejection fraction using artificial intelligence during ECG-enabled stethoscope examination in London, UK: a prospective, observational, multicentre study. Lancet Digit Health. 2022 Feb;4(2):e117-e125. doi: 10.1016/S2589-7500(21)00256-9. Epub 2022 Jan 5.</citation>
      <PMID>34998740</PMID>
    </reference>
    <reference>
      <citation>Bachtiger P, Kelshiker MA, Petri CF, Gandhi M, Shah M, Kamalati T, Khan SA, Hooper G, Stephens J, Alrumayh A, Barton C, Kramer DB, Plymen CM, Peters NS. Survival and health economic outcomes in heart failure diagnosed at hospital admission versus community settings: a propensity-matched analysis. BMJ Health Care Inform. 2023 Mar;30(1):e100718. doi: 10.1136/bmjhci-2022-100718.</citation>
      <PMID>36921978</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>cluster randomized controlled trial</keyword>
    <keyword>artificial intelligence</keyword>
    <keyword>digital health</keyword>
    <keyword>cardiology</keyword>
    <keyword>primary care</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Failure</mesh_term>
      <mesh_term>Atrial Fibrillation</mesh_term>
      <mesh_term>Cardiovascular Diseases</mesh_term>
      <mesh_term>Heart Valve Diseases</mesh_term>
      <mesh_term>Heart Murmurs</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05987670
  org study id: 22HH8045
  nct id: NCT05987670
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Open label cluster randomised controlled trial
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Incidence of heart failure (co-primary)
  time frame: 24 months
  description: Difference in incidence of coded new diagnoses of heart failure (HF)
  measure: Ratio of route to diagnosis of heart failure (co-primary) between emergency and community-based pathways
  time frame: 24 months
  description: Difference in ratio of the incidence of coded diagnoses of HF via hospital admission-based versus community-based pathways.
  measure: Incidence of atrial fibrillation
  time frame: 24 months
  description: New coded diagnoses of atrial fibrillation (AF)
  measure: Incidence of valvular heart disease
  time frame: 24 months
  description: New coded diagnoses of valvular heart disease (VHD)
  measure: Cost-consequence (AF)
  time frame: 24 months
  description: Cost-consequence analysis (form of health economic evaluation) for diagnosis of atrial fibrillation, stratified by route to diagnosis. Presented in pounds sterling.
  measure: Cost-consequence (HFrEF)
  time frame: 24 months
  description: Cost-consequence analysis (form of health economic evaluation) for diagnosis of HFrEF, stratified by route to diagnosis. Presented in pounds sterling.
  measure: Cost-consequence (VHD)
  time frame: 24 months
  description: Cost-consequence analysis (form of health economic evaluation) for diagnosis of VHD, stratified by route to diagnosis. Presented in pounds sterling.
  measure: Health service utilisation
  time frame: 24 months
  description: 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.
  measure: Proportion of patients prescribed guideline-directed medical therapy
  time frame: 24 months
  description: Proportion of patients prescribedguideline-directed medical therapy (HF, AF, VHD)
  measure: Device therapy
  time frame: 24 months
  description: New implantation of cardiac resynchronisation therapy (CRT) and/or implantable cardioverter-defibrillator (ICD)
  measure: Uptake and utilisation
  time frame: 24 months
  description: Differential rates of uptake and utilisation of AI-stethoscope in primary care
  measure: Determinants of uptake and utilisation
  time frame: 24 months
  description: Determinants of utilisation of AI-stethoscope in primary care (clinician questionnaires)
  measure: Patient quality of life
  time frame: 24 months
  description: Healthy Days at Home (patient-level analysis)
  measure: Sensitivity analysis
  time frame: 24 months
  description: 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
  arm group label: Intervention
  arm group type: Experimental
  description: Receive 3-6 AI-stethoscopes (Eko DUO, Eko Health Inc, CA, USA) including artificial intelligence software for detection of:
  Reduced left ventricular ejection fraction <40%
  Atrial fibrillation
  Cardiac murmurs
  arm group label: Control
  arm group type: No Intervention
  description: Usual care
  intervention type: Device
  intervention name: AI-stethoscope
  description: 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.
  arm group label: Intervention
  other name: Eko DUO
  other name: Eko Core 500
  other name: Eko EAS
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Nicholas S Peters, MD
  role: Principal Investigator
  affiliation: Imperial College London
  last name: Mihir Kelshiker, MD
  phone: 020 7589 5111
  email: mihir.kelshiker10@imperial.ac.uk
  citation: Bachtiger P, Petri CF, Scott FE, Ri Park S, Kelshiker MA, Sahemey HK, Dumea B, Alquero R, Padam PS, Hatrick IR, Ali A, Ribeiro M, Cheung WS, Bual N, Rana B, Shun-Shin M, Kramer DB, Fragoyannis A, Keene D, Plymen CM, Peters NS. Point-of-care screening for heart failure with reduced ejection fraction using artificial intelligence during ECG-enabled stethoscope examination in London, UK: a prospective, observational, multicentre study. Lancet Digit Health. 2022 Feb;4(2):e117-e125. doi: 10.1016/S2589-7500(21)00256-9. Epub 2022 Jan 5.
  PMID: 34998740
  citation: Bachtiger P, Kelshiker MA, Petri CF, Gandhi M, Shah M, Kamalati T, Khan SA, Hooper G, Stephens J, Alrumayh A, Barton C, Kramer DB, Plymen CM, Peters NS. Survival and health economic outcomes in heart failure diagnosed at hospital admission versus community settings: a propensity-matched analysis. BMJ Health Care Inform. 2023 Mar;30(1):e100718. doi: 10.1136/bmjhci-2022-100718.
  PMID: 36921978
  responsible party type: Sponsor
  mesh term: Heart Failure
  mesh term: Atrial Fibrillation
  mesh term: Cardiovascular Diseases
  mesh term: Heart Valve Diseases
  mesh term: Heart Murmurs
  sharing ipd: No