Non-invasive Detection of Coronary Artery Stenosis

NCT06750016 | Not Yet Recruiting

• 1 other identifier: NIDCAS002
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this viability study is to investigate using a novel medical device, the potential for detecting partial blockages in the arteries within the wall of the heart (coronary artery stenosis). A prototype device will be used in the proposed study. It is a stick-on patch containing sensors which measure the vibration produced at the chest surface by flowing blood as it accelerates through the narrowed artery in the heart emerging downstream, hitting the inner wall of the artery and causing it to vibrate. Some of the energy in the vibrations reaches the skin of the chest, allowing the blockage to be detected non-invasively. The principle has been proved in the laboratory using a simple chest model but to date no measurements have been made in people. Therefore, the proposed trial will serve as the first in-human measurements and will involve a small number of patients and healthy volunteers, with the objective of establishing if it is possible to determine the presence or absence of the stenosis. The patch will be tested by recording acoustic signatures in healthy volunteers, then in patients undergoing coronary CT angiography. Results will be validated against the CT angiography gold standard. At this early stage no clinical decisions will be made based on the patch recordings and the data will be used only to assess the feasibility of continuing the development of the device.

Conditions

Coronary Arterial Disease (CAD)

Keywords

Stenosis; Turbulent flow; Acoustic signature

Outcome Measures

Primary Outcomes (1)

• Accuracy

  Diagnostic accuracy of the device (stick-on patch) for indicating the presence or absence of one or more coronary arterial stenoses as indicated by the reference method (angiography/CT angiography results). This will be expressed as: Np/(Na+Np) x100. Where: Np is the number of positive diagnoses of coronary artery disease derived from the patch measurements Na is the number of positive diagnoses of coronary artery disease (with at least one lesion showing a reduction in maximum stenosis lumen diameter 0.8 of more) derived from the angiography images. This is a dimensionless quantity

  Immediately following patch recording and imaging

Secondary Outcomes (3)

• Stenosis severity

  Immediately following the patch recordings and imaging

• Patch wearability

  Immediately following the patch recordings and imaging

• Ease of patch removal

  Immediately following the patch recordings and imaging

Study Arms (2)

Coronary Artery Disease (CAD)

Patients in whom occlusive coronary artery disease has been diagnosed by angiography or CT angiography

Control

Healthy volunteers and/or patients in whom no CAD has been identified on angiography or CT angiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Approximately equal numbers of symptomatic and asymptomatic subjects undergoing angiography or CT angiography at the Cleveland Clinic, London, UK

You may qualify if:

• Patient is able to provide written informed consent
• Age ≥18 years;
• Investigation for suspected stable coronary artery disease/stenosis isolated from other cardiac comorbidities.
• Subjects of either sex. Female subjects of child-bearing potential will be included if deemed suitable for clinically mandated coronary CTa.
• No infectious disease or neoplasia.

You may not qualify if:

• Indications to coronary CTa different from isolated suspected stable coronary artery disease, such as acute coronary syndrome, unstable angina, congenital heart disease, cardiomyopathy, heart valve disease, aortic coarctation, electrophysiological disorder/arrhythmia, screening study, unstable clinical condition, left ventricular ejection fraction \<35%, previous coronary revascularization (PCI or CABG surgery), previous heart valve surgery or transcatheter valve replacement, pace maker or implantable defibrillator.
• If female and of child-bearing potential: evidence of a positive pregnancy test or a stated intention to become pregnant in the next 6-12 months;
• Currently participating in another device or drug study or has done so in previous 3 months.

Sponsors & Collaborators

• Nilocas: lead
• Queen Mary University of London: collaborator

Study Sites (1)

Cleveland Clinic Portland Place Outpatient Centre 24 Portland Place

London, W1B 1LU, United Kingdom

Location

Related Publications (4)

• Banks HT, Hu S, Kenz ZR, Kruse C, Shaw S, Whiteman J, Brewin MP, Greenwald SE, Birch MJ. Model validation for a noninvasive arterial stenosis detection problem. Math Biosci Eng. 2014 Jun;11(3):427-48. doi: 10.3934/mbe.2014.11.427.

  PMID: 24506547 BACKGROUND

• Brewin MP, Birch MJ, Mehta DJ, Reeves JW, Shaw S, Kruse C, Whiteman JR, Hu S, Kenz ZR, Banks HT, Greenwald SE. Characterisation of Elastic and Acoustic Properties of an Agar-Based Tissue Mimicking Material. Ann Biomed Eng. 2015 Oct;43(10):2587-96. doi: 10.1007/s10439-015-1294-7. Epub 2015 Mar 14.

  PMID: 25773982 BACKGROUND

• Sangster JF, Oakley CM. Diastolic murmur of coronary artery stenosis. Br Heart J. 1973 Aug;35(8):840-4. doi: 10.1136/hrt.35.8.840. No abstract available.

  PMID: 4542336 BACKGROUND

• Semmlow J, Rahalkar K. Acoustic detection of coronary artery disease. Annu Rev Biomed Eng. 2007;9:449-69. doi: 10.1146/annurev.bioeng.9.060906.151840.

  PMID: 17425468 BACKGROUND

MeSH Terms

Conditions

Constriction, Pathologic

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Francesca Pugliese, MD

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen E Greenwald, PhD

CONTACT

+44 7849458798; s.e.greenwald@qmul.ac.uk

Mark Aichroth

CONTACT

‭+44 7767 640986‬

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiovascular Mechanics

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 27, 2024
• Study Start: May 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)