Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in the UK / NCT06750016
Starting soon Observational

Non-invasive Detection of Coronary Artery Stenosis

NCT06750016 · tracked via the Priya Life Science UK tracker
Sponsor
Nilocas
Phase
Observational
Started
2025-05
Last updated
2024-12-27

Condition(s) studied

Coronary Arterial Disease (CAD)

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: 1. Patient is able to provide written informed consent 2. Age ≥18 years; 3. Investigation for suspected stable coronary artery disease/stenosis isolated from other cardiac comorbidities. 4. Subjects of either sex. Female subjects of child-bearing potential will be included if deemed suitable for clinically mandated coronary CTa. 5. No infectious disease or neoplasia. Exclusion Criteria: 1. 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. 2. 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; 3. Currently participating in another device or drug study or has done so in previous 3 months.

Primary outcome measure(s)

  • Accuracy — Immediately following patch recording and imaging
    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

Trial sites (1)

FacilityCityRegionStatus
Cleveland Clinic Portland Place Outpatient Centre 24 Portland Place London United Kingdom

Other trials for the same condition

Focused Orticumab Research for Treating Inflammation in Coronary Arteries Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study Recruiting
FORWARD CAD IDE Study Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06750016 on ClinicalTrials.gov ↗ ← All trials in the UK