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Multisensor Array for the Localisation of Coronary Artery Stenosis (MALCAS)

NCT04647448 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2025-02-11

No results posted yet for this study

Summary

This is a proof of concept study involving a novel medical device, developed to investigate the potential for detecting and localising coronary artery stenosis. A prototype device will be used in the proposed clinical investigation. It is a stick-on patch containing sensors which measure the sound produced at and the movement of, the chest surface by flowing blood as it accelerates through the stenosis and becomes disturbed as it emerges downstream, allowing the blockage to be detected and localised non-invasively.

The proposed clinical investigation will involve a small number of patients and healthy volunteers. The patients will be drawn from those attending The BartsHeart Centre for suspected or diagnosed coronary artery disease and all clinical measurements will take place at Barts Health Trust. The patch to be used in the proposed clinical investigation incorporates commercially available sensors and will be tested by recording acoustic signatures in healthy volunteers, then in patients undergoing coronary CT angiography at Barts. Signals will be analysed initially by measuring their acoustic energy at various frequencies and in later iterations, by a machine-learning algorithm. Results will be validated against the CT angiography gold standard.

Conditions

Interventions

DIAGNOSTIC_TEST

Application of sensor patch

Application of sensor patch to chest to record acoustic signals due to disturbed blood flow.

Sponsors & Collaborators

  • Imperial College London

    collaborator OTHER

  • Brunel University

    collaborator OTHER

  • Barts & The London NHS Trust

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2026-08-31
Completion
2026-12-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04647448 on ClinicalTrials.gov