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.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Speed of reporting
研究概览
简要总结
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.
详细描述
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.
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Data that will be collected will include:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical CCTA
- •Able to provide informed consent
排除标准
- •Unable / unwilling to give informed consent
- •Previous CABG or stent insertion
结局指标
主要结局
Speed of reporting
时间窗: 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
时间窗: 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.
次要结局
- Speed assessing plaque vulnerability(Through study completion, up to 26 weeks)