Triple Cardiovascular Disease Detection With an Artificial Intelligence-enabled Stethoscope

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

• Imperial College Health Partners

  collaborator UNKNOWN

• Imperial College London

  lead OTHER

Principal Investigators

• Nicholas S Peters, MD · Imperial College London

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-10-25

Primary Completion

2025-12-23

Completion

2025-12-23

FDA Device

Yes

Countries

• United Kingdom

Study Locations