Coronary Arterial Disease (CAD)NIDCASNCT06750016
Non-invasive Detection of Coronary Artery Stenosis
An observational study of Coronary Arterial Disease (CAD), run by Nilocas at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Arterial Disease (CAD)
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2025to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Approximately equal numbers of symptomatic and asymptomatic subjects undergoing angiography or CT angiography at the Cleveland Clinic, London, UK
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mark Aichroth contact
United Kingdom1 site
Cleveland Clinic Portland Place Outpatient Centre 24 Portland Place
London, W1B 1LU
About this study
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.
Read the detailed description
This feasibility study is a non-randomised, proof of concept study being undertaken at a single clinical centre. It involves a novel, non-invasive battery powered medical device that is not CE marked. As a non-CE marked device, review and approval of the proposed clinical investigation a UK Competent Authority, the HRA, is required in addition to ethical review and approval.
The device, a patch containing microphones and accelerometers applied to the chest, is battery powered and will not introduce any energy or substances into the subjects involved in the study. The device will listen for sounds and movement within the body of the individual being examined. The signals detected by the microphones and accelerometers are transmitted wirelessly to a data acquisition unit which is connected to a laptop computer more than 2 metres away from the patient, which displays the signals in real time and stores them for later analysis off-line.
Data (acoustic signatures) will be collected from patients with known or suspected coronary artery disease. Results will be compared with the current gold standard of coronary angiography or coronary CT angiography.
The risk to participants is minimal. No specific risks associated with the use of the device have been identified and no requirement for additional testing has been identified. There are no anticipated interactions with concomitant medical treatments.
The results of this study will not be used to manage the treatment pathway of the patient involved.
If proof of concept is successfully demonstrated with the new device, a larger randomised study will be undertaken to obtain the clinical data necessary to support commercial and regulatory requirements.
Having conducted in-vitro proof of principle experiments (as listed in the references section) and before conducting a formal validation trial, we wish to determine the viability of the new patch device in an initial study on a small number of patients undergoing coronary angiography. We aim firstly, to prove the principle that it is possible to distinguish between those with and those without coronary artery stenosis and, secondly to assess how well the device is tolerated by the patient and how easy it is to deploy the patch and take readings 'in the field'. We believe that this small trial is essential to provide first in human data to support applications for funding a larger validation trial.
Potential study participants will be recruited from patients attending, the Cleveland Clinic who have agreed to elective angiography or CTa investigation. All potential participants will be screened against the inclusion and exclusion criteria detailed elsewhere. This is a non-randomised study. Accordingly, participants will be recruited i on a sequential basis until a total sample size of at least 20 is reached.
Written Informed Consent will be obtained from all participants before recruitment into the study and this will be recorded on the consent form. The nature of the measurements and the nature of the clinical investigation, together with all procedures and risks will be fully explained to each prospective participant by one of the Investigators or members of the research team. If the patient meets all inclusion/exclusion criteria and agrees to participate in the study, he/she will be invited to sign the approved CF.
When the potential subject has agreed to take part, they will undergo the following procedures (approximate times in brackets).
- Height, weight and blood pressure recording. (15 minutes)
- CTa or angiography scan as normal. (30 minutes)
- Patch attached and wireless connection to remote receiver established.
- The patch will be adjusted to ensure that the patient is comfortable
- Data recorded. (15 minutes)
- Patch removed. (5 minutes)
- Subject asked to suggest any aspects of the procedure that might be improved. All comments noted. (10 minutes)
The patch data will be analysed blind by a member of our team who would not take part in the recording sessions. For the analysis the time series data will be transformed to the frequency domain and the relative acoustic power detected by each sensor over various frequency range will be tabulated. For this small preliminary study, the agreement between the reference and test method to determine the categorical variable namely, the presence or absence of a coronary artery stenosis, will be assessed by Cohen's Kappa test. This measures how much the agreement between the two methods exceeds what would be expected by chance. At this early stage no further statistical tests are planned.
- Conditions
- Coronary Arterial Disease (CAD)
- Keywords
- Stenosis, Turbulent flow, Acoustic signature
- Medical subject headings
- Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediately following patch recording and imaging
Secondary outcomes (3)
Stenosis severity
In subjects in whom one or more stenoses are identified by the reference method:
Comparison of the magnitude of the disturbed flow to the severity of the stenosis as measured from the CTa images.
The comparison will be made by assessing the significance of the linear correlation coefficient between the average power of the patch signals in the frequency domain (in the frequency range 20 - 500 Hz) and the stenosis severity defined as the ratio of the minimum stenosis diameter to the mean diameter of the coronary artery immediately proximal to the stenosis. (Note that this is at best, a semi-quantitative measure and with the small number of subjects proposed for this viability trial the results are for guidance only.)
Measured: Immediately following the patch recordings and imaging
Patch wearability
Assessment of the subject's comfort when wearing the device. This will be quantified using a Visual Analog Score between 1 and 10, 1 being the least comfortable and 10, the most.
Measured: Immediately following the patch recordings and imaging
Ease of patch removal
Ease of removal at the end of a measurements session. This will be quantified quantified using a Visual Analog Score between 1 and 10, 1 being the least comfortable and 10, the most.
Measured: Immediately following the patch recordings and imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study startMay 2025 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary Arterial Disease (CAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nilocas
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Queen Mary University of London
- Responsible party
- Principal investigator, Stephen Greenwald, Nilocas
- Investigators
- Francesca Pugliese, MD, Principal investigator, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750016
- Sponsor's protocol ID
- NIDCAS002
- Acronym
- NIDCAS
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The results of this preliminary viability study will be described in an internal report and this will be used to provided evidence when seeking funding for a larger validation trial. They will not therefore be published.
Publications
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.
PubMed 24506547Brewin 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.
PubMed 25773982Sangster 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.
PubMed 4542336Semmlow 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.
PubMed 17425468
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Detection of Coronary Artery Stenosis
- ClinicalTrials.gov ID
- NCT06750016
- Acronym / sponsor ID
- NIDCAS / NIDCAS002
- Conditions
- Coronary Arterial Disease (CAD)
- Keywords
- Stenosis, Turbulent flow, Acoustic signature
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- NilocasIndustry (pharma, biotech, devices)
- Collaborators
- Queen Mary University of London
- Study start
- May 2025 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This feasibility study is a non-randomised, proof of concept study being undertaken at a single clinical centre. It involves a novel, non-invasive battery powered medical device that is not CE marked. As a non-CE marked device, review and approval of the proposed clinical investigation a UK Competent Authority, the HRA, is required in addition to ethical review and approval.
The device, a patch containing microphones and accelerometers applied to the chest, is battery powered and will not introduce any energy or substances into the subjects involved in the study. The device will listen for sounds and movement within the body of the individual being examined. The signals detected by the microphones and accelerometers are transmitted wirelessly to a data acquisition unit which is connected to a laptop computer more than 2 metres away from the patient, which displays the signals in real time and stores them for later analysis off-line.
Data (acoustic signatures) will be collected from patients with known or suspected coronary artery disease. Results will be compared with the current gold standard of coronary angiography or coronary CT angiography.
The risk to participants is minimal. No specific risks associated with the use of the device have been identified and no requirement for additional testing has been identified. There are no anticipated interactions with concomitant medical treatments.
The results of this study will not be used to manage the treatment pathway of the patient involved.
If proof of concept is successfully demonstrated with the new device, a larger randomised study will be undertaken to obtain the clinical data necessary to support commercial and regulatory requirements.
Having conducted in-vitro proof of principle experiments (as listed in the references section) and before conducting a formal validation trial, we wish to determine the viability of the new patch device in an initial study on a small number of patients undergoing coronary angiography. We aim firstly, to prove the principle that it is possible to distinguish between those with and those without coronary artery stenosis and, secondly to assess how well the device is tolerated by the patient and how easy it is to deploy the patch and take readings 'in the field'. We believe that this small trial is essential to provide first in human data to support applications for funding a larger validation trial.
Potential study participants will be recruited from patients attending, the Cleveland Clinic who have agreed to elective angiography or CTa investigation. All potential participants will be screened against the inclusion and exclusion criteria detailed elsewhere. This is a non-randomised study. Accordingly, participants will be recruited i on a sequential basis until a total sample size of at least 20 is reached.
Written Informed Consent will be obtained from all participants before recruitment into the study and this will be recorded on the consent form. The nature of the measurements and the nature of the clinical investigation, together with all procedures and risks will be fully explained to each prospective participant by one of the Investigators or members of the research team. If the patient meets all inclusion/exclusion criteria and agrees to participate in the study, he/she will be invited to sign the approved CF.
When the potential subject has agreed to take part, they will undergo the following procedures (approximate times in brackets).
- Height, weight and blood pressure recording. (15 minutes)
- CTa or angiography scan as normal. (30 minutes)
- Patch attached and wireless connection to remote receiver established.
- The patch will be adjusted to ensure that the patient is comfortable
- Data recorded. (15 minutes)
- Patch removed. (5 minutes)
- Subject asked to suggest any aspects of the procedure that might be improved. All comments noted. (10 minutes)
The patch data will be analysed blind by a member of our team who would not take part in the recording sessions. For the analysis the time series data will be transformed to the frequency domain and the relative acoustic power detected by each sensor over various frequency range will be tabulated. For this small preliminary study, the agreement between the reference and test method to determine the categorical variable namely, the presence or absence of a coronary artery stenosis, will be assessed by Cohen's Kappa test. This measures how much the agreement between the two methods exceeds what would be expected by chance. At this early stage no further statistical tests are planned.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately equal numbers of symptomatic and asymptomatic subjects undergoing angiography or CT angiography at the Cleveland Clinic, London, UK
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy
Time frame: 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
3 secondary outcomes
Stenosis severity
Time frame: Immediately following the patch recordings and imaging
Patch wearability
Time frame: Immediately following the patch recordings and imaging
Ease of patch removal
Time frame: Immediately following the patch recordings and imaging
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Background: PubMed 24506547Banks 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.
- Background: PubMed 25773982Brewin 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.
- Background: PubMed 4542336Sangster 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.
- Background: PubMed 17425468Semmlow 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.
- Individual participant dataSharing planned: No. The results of this preliminary viability study will be described in an internal report and this will be used to provided evidence when seeking funding for a larger validation trial. They will not therefore be published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark Aichroth contact
Francesca Pugliese, MD principal investigator
Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Arterial Disease (CAD), run by Nilocas at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephen E Greenwald, PhD (+44 7849458798, s.e.greenwald@qmul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy (time frame: Immediately following patch recording and imaging). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06750016, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.