Coronary Artery DiseaseEAIRNCT05583968
Efficiency of AI Reporting (EAIR).
An observational study of Coronary Artery Disease, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
While there are features on a CCTA that are correlated with plaque vulnerability and can be reported on, this is not always done. This is important as it is thought that vulnerable plaques present the greatest risk of myocardial infarction. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Aug 2024to 9 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who have been referred for CCTA over the last 12 months will be invited to take part. The rationale is to test this software in a real-world setting and this method will provide a non-selective sample. No patient will be contacted until their vital status has been checked on the national SPINE database.
Who may be able to join
- Clinical CCTA
- Able to provide informed consent
Who cannot join
- Unable / unwilling to give informed consent
- Previous CABG or stent insertion
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
London North West University Healthcare NHS Trust
Harrow, Middx, HA1 3UJ
About this study
Official title: Evaluation of the Efficiency and Accuracy of Artrya-Salix AI Software in the Reporting of Coronary Computed Tomography Angiography Scans in a Real-world NHS Setting. A Retrospective Study.
While there are features on a CCTA that are correlated with plaque vulnerability and can be reported on, this is not always done. This is important as it is thought that vulnerable plaques present the greatest risk of myocardial infarction. This study will assess the correlation between software and human classification of these plaques, as well as demonstrating the time efficiency of AI reporting when compared to a clinician.
Read the detailed description
This is a retrospective observational study. It will be performed at London Northwest Healthcare NHS Trust (LNWH -Northwick Park Hospital (NPH), Harrow and Ealing Hospital, Southall).
Patients who have had a CCTA in the last 12 months will be contacted about the study. Their CCTA scans will already have been reported and the patient aware of the results. After giving informed consent, 100 patients will have their clinical CCTA images uploaded to the Artrya Salix software for analysis. Simultaneously the images will be re-reported by the physician as per standard of care. Both reports will be obtained and any differences noted. The time the images are sent to Artrya Salix and report received will be recorded. The time the clinician opens the image to analyse and the time when the report is complete will also be recorded using a stopwatch. All images will be analysed by both expert readers to take account of inter-observer variability. The first 30 patients will be treated as a pilot for the study and after their recruitment and image upload and analysis, the team will meet to discuss any issues that have arisen.
During the analysis, any patient who has plaque identified by the software or expert reader will have further analysis of their images. This is to look at the plaques in detail and to compare the sensitivity and specificity of the expert reader analysis. The time it takes for the clinician to report the scans on this group of patients will also be recorded. In addition, assessment will be made of the plaques using comparison of stenosis to calcium score.
.
Data that will be collected will include:
- Demographic data (age, gender, ethnicity)
- CCTA results - standard of care
- CCTA results - Artrya Salix
- Time from image upload to Artrya Salix to time report received from Artrya Salix
- Time clinician takes to analyse scan
- Clinical assessment of plaque for vulnerable characteristics.
The data will be from the electronic medical records of LNWUH NHS Trust. A level 2 or level 3 Cardiology imaging or Radiology Consultant will report the CCTA images.
Data will be captured on an eCRF. The time of image upload to Artrya Salix will be recorded by the system and transposed directly into the eCRF. The time starting and ending image analysis by the clinician will be recorded on a worksheet as source documentation and then entered into the eCRF. A score will be given by the physician as to the likelihood of a plaque being vulnerable where 1= unlikely and 5 = highly likely.
- Conditions
- Coronary Artery Disease
- Keywords
- Artificial Intelligence, Coronary Artery Disease, CCTA, atherosclerotic plaque, vulnerable plaque
- Medical subject headings
- Coronary Artery Disease, Plaque, Atherosclerotic
What is being measured
The primary outcome is the main question the study is designed to answer.
Speed of reporting
- Time taken for Artrya Salix reporting of a CCTA scan is as fast or faster than clinician reporting
Measured: Through study completion, up to 26 weeks
Vulnerable plaque identification
- In a subset of patients where the software has identified vulnerable plaques, this is in agreement with the expert clinical report.
Measured: Through study completion, up to 26 weeks
Secondary outcomes (1)
Speed assessing plaque vulnerability
The secondary outcome of this study will be the additional time taken by the clinician to report plaque vulnerability characteristics.
Measured: Through study completion, up to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start15 Aug 2024 (estimated)
- Primary completion9 Feb 2025 (estimated)
- Study completion9 Mar 2025 (estimated)
Why it stopped: sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- London North West Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Navtej Chahal, PhD FESC, Principal investigator, LNWUH NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583968
- Sponsor's protocol ID
- CRC/2021/003
- Acronym
- EAIR
- Status last verified
- May 2025
- First submitted
- 30 May 2022
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: dat will be fully anonymous and will remain within the study team.
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficiency and Accuracy of Artrya-Salix AI Software in the Reporting of Coronary Computed Tomography Angiography Scans in a Real-world NHS Setting. A Retrospective Study.
- ClinicalTrials.gov ID
- NCT05583968
- Acronym / sponsor ID
- EAIR / CRC/2021/003
- Conditions
- Coronary Artery Disease
- Keywords
- Artificial Intelligence, Coronary Artery Disease, CCTA, atherosclerotic plaque, vulnerable plaque
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- London North West Healthcare NHS TrustUniversity, hospital or other
- Study start
- 15 Aug 2024 (estimated)
- Primary completion
- 9 Feb 2025 (estimated)
- Study completion
- 9 Mar 2025 (estimated)
- First posted
- 18 Oct 2022 (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.
While there are features on a CCTA that are correlated with plaque vulnerability and can be reported on, this is not always done. This is important as it is thought that vulnerable plaques present the greatest risk of myocardial infarction. This study will assess the correlation between software and human classification of these plaques, as well as demonstrating the time efficiency of AI reporting when compared to a clinician.
Detailed description
This is a retrospective observational study. It will be performed at London Northwest Healthcare NHS Trust (LNWH -Northwick Park Hospital (NPH), Harrow and Ealing Hospital, Southall).
Patients who have had a CCTA in the last 12 months will be contacted about the study. Their CCTA scans will already have been reported and the patient aware of the results. After giving informed consent, 100 patients will have their clinical CCTA images uploaded to the Artrya Salix software for analysis. Simultaneously the images will be re-reported by the physician as per standard of care. Both reports will be obtained and any differences noted. The time the images are sent to Artrya Salix and report received will be recorded. The time the clinician opens the image to analyse and the time when the report is complete will also be recorded using a stopwatch. All images will be analysed by both expert readers to take account of inter-observer variability. The first 30 patients will be treated as a pilot for the study and after their recruitment and image upload and analysis, the team will meet to discuss any issues that have arisen.
During the analysis, any patient who has plaque identified by the software or expert reader will have further analysis of their images. This is to look at the plaques in detail and to compare the sensitivity and specificity of the expert reader analysis. The time it takes for the clinician to report the scans on this group of patients will also be recorded. In addition, assessment will be made of the plaques using comparison of stenosis to calcium score.
.
Data that will be collected will include:
- Demographic data (age, gender, ethnicity)
- CCTA results - standard of care
- CCTA results - Artrya Salix
- Time from image upload to Artrya Salix to time report received from Artrya Salix
- Time clinician takes to analyse scan
- Clinical assessment of plaque for vulnerable characteristics.
The data will be from the electronic medical records of LNWUH NHS Trust. A level 2 or level 3 Cardiology imaging or Radiology Consultant will report the CCTA images.
Data will be captured on an eCRF. The time of image upload to Artrya Salix will be recorded by the system and transposed directly into the eCRF. The time starting and ending image analysis by the clinician will be recorded on a worksheet as source documentation and then entered into the eCRF. A score will be given by the physician as to the likelihood of a plaque being vulnerable where 1= unlikely and 5 = highly likely.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have been referred for CCTA over the last 12 months will be invited to take part. The rationale is to test this software in a real-world setting and this method will provide a non-selective sample. No patient will be contacted until their vital status has been checked on the national SPINE database.
Key inclusion criteria (2 listed)
- Clinical CCTA
- Able to provide informed consent
Key exclusion criteria (2 listed)
- Unable / unwilling to give informed consent
- Previous CABG or stent insertion
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
Speed of reporting
Time frame: Through study completion, up to 26 weeks
1. Time taken for Artrya Salix reporting of a CCTA scan is as fast or faster than clinician reporting
Vulnerable plaque identification
Time frame: Through study completion, up to 26 weeks
2. In a subset of patients where the software has identified vulnerable plaques, this is in agreement with the expert clinical report.
1 secondary outcome
Speed assessing plaque vulnerability
Time frame: Through study completion, up to 26 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Individual participant dataSharing planned: No. dat will be fully anonymous and will remain within the study team.
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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. This study is not recruiting at the moment.
Navtej Chahal, PhD FESC principal investigator
LNWUH NHS Trust
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 Artery Disease, run by London North West Healthcare NHS Trust 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 2 inclusion and 2 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: withdrawn, as of the sponsor's last update on 23 May 2025. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speed of reporting (time frame: Through study completion, up to 26 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 May 2025.