Triple Cardiovascular Disease Detection With an Artificial Intelligence-enabled Stethoscope
Heart Failure · Heart Valve Diseases · Atrial Fibrillation · Heart Murmurs · Congestive Heart Failure · Heart Failure With Reduced Ejection Fraction
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 200 Real
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Acerca de la investigación
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.
Leer la descripción completa
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.
¿Quién podría participar?
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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
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Asignación al azar
- Enmascaramiento
- Sin enmascaramiento
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
Control
Usual care
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
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.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Incidence of heart failure (co-primary)
Plazo: 24 months
Difference in incidence of coded new diagnoses of heart failure (HF)
Ratio of route to diagnosis of heart failure (co-primary) between emergency and community-based pathways
Plazo: 24 months
Difference in ratio of the incidence of coded diagnoses of HF via hospital admission-based versus community-based pathways.
Medidas secundarias
Incidence of atrial fibrillation
Plazo: 24 months
New coded diagnoses of atrial fibrillation (AF)
Incidence of valvular heart disease
Plazo: 24 months
New coded diagnoses of valvular heart disease (VHD)
Cost-consequence (AF)
Plazo: 24 months
Cost-consequence analysis (form of health economic evaluation) for diagnosis of atrial fibrillation, stratified by route to diagnosis. Presented in pounds sterling.
Cost-consequence (HFrEF)
Plazo: 24 months
Cost-consequence analysis (form of health economic evaluation) for diagnosis of HFrEF, stratified by route to diagnosis. Presented in pounds sterling.
Cost-consequence (VHD)
Plazo: 24 months
Cost-consequence analysis (form of health economic evaluation) for diagnosis of VHD, stratified by route to diagnosis. Presented in pounds sterling.
Health service utilisation
Plazo: 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.
Proportion of patients prescribed guideline-directed medical therapy
Plazo: 24 months
Proportion of patients prescribedguideline-directed medical therapy (HF, AF, VHD)
Device therapy
Plazo: 24 months
New implantation of cardiac resynchronisation therapy (CRT) and/or implantable cardioverter-defibrillator (ICD)
Uptake and utilisation
Plazo: 24 months
Differential rates of uptake and utilisation of AI-stethoscope in primary care
Determinants of uptake and utilisation
Plazo: 24 months
Determinants of utilisation of AI-stethoscope in primary care (clinician questionnaires)
Patient quality of life
Plazo: 24 months
Healthy Days at Home (patient-level analysis)
Otras medidas
Sensitivity analysis
Plazo: 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
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
NHS North West London Integrated Care SystemLondon, United KingdomEstado desconocido
Equipo y fechas
- Patrocinador principal
- Imperial College London
- Inicio del estudio
- 25 oct 2023 Real
- Finalización primaria
- 23 jun 2028 Estimado
- Finalización del estudio
- 23 jun 2028 Estimado
- Primera publicación
- 14 ago 2023 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
Triple Cardiovascular Disease Detection With an Artificial Intelligence-enabled Stethoscope
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026