NCT05987670: TRICORDER

Triple Cardiovascular Disease Detection With an Artificial Intelligence-enabled Stethoscope

Active, enrolled NA Last updated 11 July 2024

What this trial tests

NA trial testing AI-stethoscope in Heart Failure in 200 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

25 October 2023

Primary endpoint
23 December 2025

23 December 2025

Quick facts

Lead sponsor	Imperial College London
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	200
Start date	25 October 2023
Primary completion	23 December 2025
Estimated completion	23 December 2025
Sites	1 location across United Kingdom

Drugs / interventions tested

• AI-stethoscope

Conditions studied

• Heart Failure — all drugs for Heart Failure →
• Heart Valve Diseases — all drugs for Heart Valve Diseases →
• Atrial Fibrillation — all drugs for Atrial Fibrillation →
• Heart Murmurs — all drugs for Heart Murmurs →

Sponsor

Imperial College London

Who can join

18 and older, any sex, with Heart Failure or Heart Valve Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Triple cardiovascular disease detection with an artificial intelligence-enabled stethoscope (TRICORDER): design and rationale for a decentralised, real-world cluster-randomised controlled trial and implementation study.
   Kelshiker MA, Bächtiger P, Mansell J, Kramer DB, et al · · 2025 · cited 3× · PMID 40398956 · DOI 10.1136/bmjopen-2024-098030
2. Artificial intelligence analysis of the single-lead ECG predicts long-term clinical outcomes.
   Alrumayh A, Bächtiger P, Sau A, Mansell J, et al · · 2025 · PMID 40703135 · DOI 10.1093/ehjdh/ztaf057