Efficiency of AI Reporting (EAIR).

NCT05583968 | Withdrawn

• 1 other identifier: CRC/2021/003
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Coronary Artery Disease

Keywords

Artificial Intelligence; Coronary Artery Disease; CCTA; atherosclerotic plaque; vulnerable plaque

Outcome Measures

Primary Outcomes (2)

• Speed of reporting

  1\. Time taken for Artrya Salix reporting of a CCTA scan is as fast or faster than clinician reporting

  Through study completion, up to 26 weeks

• Vulnerable plaque identification

  2\. In a subset of patients where the software has identified vulnerable plaques, this is in agreement with the expert clinical report.

  Through study completion, up to 26 weeks

Secondary Outcomes (1)

• Speed assessing plaque vulnerability

  Through study completion, up to 26 weeks

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Clinical CCTA
• Able to provide informed consent

You may not qualify if:

• Unable / unwilling to give informed consent
• Previous CABG or stent insertion

Sponsors & Collaborators

• London North West Healthcare NHS Trust: lead

Study Sites (1)

London North West University Healthcare NHS Trust

Harrow, Middx, HA1 3UJ, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease; Plaque, Atherosclerotic

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Navtej Chahal, PhD FESC

  LNWUH NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2022
• First Posted: October 18, 2022
• Study Start: August 15, 2024
• Primary Completion: February 9, 2025
• Study Completion: March 9, 2025
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)