NCT05987670

Triple Cardiovascular Disease Detection With an Artificial Intelligence-enabled Stethoscope

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 (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.

Conditions

• Heart Failure
• Heart Valve Diseases
• Atrial Fibrillation
• Heart Murmurs
• Congestive Heart Failure
• Heart Failure With Reduced Ejection Fraction

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-10-25
• Primary completion: 2025-12-23
• Completion: 2025-12-23
• First posted: 2023-08-14
• Last updated: 2024-07-11

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated device study