A CCTA Image Assisted Triage Software for the Assessment of Patients With Suspected Coronary Artery Disease

Study Overview
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Brief Summary
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The goal of this clinical trail is to evaluate the effectiveness and accuracy of the CCTA image assisted triage software(DeepVessel® Cardisight, Keya Medical.) for the triage of patients with suspected coronary artery disease.

Detailed Description
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The CCTA images collected by each center within a certain period of time would be screened, desensitized, and then evaluated by the software and independent expert group respectively, to evaluate the effectiveness and accuracy of the coronary CT angiography image stenosis assisted triage software developed by Koyal Medical Technology Co. Experiment group: Evaluated by the software Independent expert group: Evaluated by experts (≥5 years of CCTA experience required)

Official Title
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A CCTA Image Assisted Triage Software for the Assessment of Patients With Suspected Coronary Artery Disease: a Retrospective, Multi-center, Blind-evaluation Study

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CCTA images acquired by CT detectors need to meet the following requirements: Check Modal = CT Number of detector rows ≥ 64 rows Layer thickness ≤1mm Layer spacing ≤1mm Pixel pitch ≤ 0.5mm Ball tube voltage ≥ 70kV Number of layers ≥ 100 layers CCTA image quality score ≥ 3 (5-point Likert scale). Exclusion Criteria: Severe coronary artery calcification, which in the judgment of readers affects the stenosis adjudicator; Previous percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG); Congenital anomalies of coronary artery origin or other malformations; Coronary artery occlusive lesions; Implantation of the pacemaker, internal defibrillator electrode, or prosthetic heart valve.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Suspected patients with coronary heart disease.<br>The coronary CT angiography (CCTA) images collected by each center within a certain period of time will be desensitized after the screening is successful. The final CCTA images were sent to an independent judgment expert group for diagnosis, the results of the test group and the independent judgment expert group were compared, and the clinical application of the coronary artery CT angiography image vascular stenosis auxiliary triage software developed by Keya Medical Technology Co., Ltd. was evaluated. Validity and Accuracy | Other: No intervention<br>* Due to observational study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of experiment group in triage for patients with suspected coronary artery disease | Based on the results of the independent expert group, uses stenosis degree≥50% as the boundary for triage indication on a per-patient basis. | October 13,2022 to March 1,2023 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic time | Independent expert group: recording the sum of image post-processing time (T1) and the time to produce the results (T2); Experimental group: recording the time from image post-processing to outputting results; Calculate the difference between the two groups. | October 13,2022 to March 1,2023 | 
| Patient as research unit | Evaluation criteria were established based on the results of the independent expert group to evaluate the total conformity rate, KAPPA value, positive predictive value (PPV) and negative predictive value (NPV) of triage tips for patients with suspected coronary heart disease in the experimental group. | October 13,2022 to March 1,2023 | 
| Blood vessels were used as the research unit | Evaluation criteria were established based on the results of the independent expert group to evaluate the total conformity rate, KAPPA value, positive predictive value (PPV) and negative predictive value (NPV) of triage tips for patients with suspected coronary heart disease in the experimental group. | October 13,2022 to March 1,2023 | 
| The vascular segment was used as the research unit | Evaluation criteria were established based on the results of the independent expert group to evaluate the total conformity rate, KAPPA value, positive predictive value (PPV) and negative predictive value (NPV) of triage tips for patients with suspected coronary heart disease in the experimental group. | October 13,2022 to March 1,2023 | 
| Gender stratified statistics, respectively, with patients and blood vessels as research units | Evaluation criteria were established based on the results of the independent expert group to evaluate the sensitivity and specificity of the trial group to the triage hints of suspected patients with coronary heart disease | October 13,2022 to March 1,2023 | 
| Manufacturer stratified statistics, respectively, with patients and blood vessels as research units | Evaluation criteria were established based on the results of the independent expert group to evaluate the sensitivity and specificity of the trial group to the triage hints of suspected patients with coronary heart disease | October 13,2022 to March 1,2023 | 
| Row number stratified statistics, respectively, with patients and blood vessels as research units | Evaluation criteria were established based on the results of the independent expert group to evaluate the sensitivity and specificity of the trial group to the triage hints of suspected patients with coronary heart disease | October 13,2022 to March 1,2023 | 
| The stratified statistics of tube voltage were conducted with patients and blood vessels as research units | Evaluation criteria were established based on the results of the independent expert group to evaluate the sensitivity and specificity of the trial group to the triage hints of suspected patients with coronary heart disease | October 13,2022 to March 1,2023 | 
| Layer thickness stratified statistics, patients and blood vessels were used as research units | Evaluation criteria were established based on the results of the independent expert group to evaluate the sensitivity and specificity of the trial group to the triage hints of suspected patients with coronary heart disease | October 13,2022 to March 1,2023 | 
| The patients and blood vessels were selected as the research units | Evaluation criteria were established based on the results of the independent expert group to evaluate the sensitivity and specificity of the trial group to the triage hints of suspected patients with coronary heart disease | October 13,2022 to March 1,2023 | 
| Post-processing image quality evaluation | Calculate the percentage of post-processing images with the image quality score of 2 or above in the total post-processing images, and the difference between the independent expert group and experimental group. | October 13,2022 to March 1,2023 | 
| Software performance evaluation | From the function of use, ease of operation, stability to evaluate, divided into satisfactory, general, unsatisfactory three levels. | October 13,2022 to March 1,2023 |