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.
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)
Study Type
OBSERVATIONAL
Enrollment
1,093
Due to observational study
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
The Pearl River Hospital of Southern Medical University
Guangzhou, Guangdong, China
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China
The First Affiliated Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
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.
Time frame: October 13,2022 to March 1,2023
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Huanggang Central Hospital
Huanggang, Hubei, China
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: October 13,2022 to March 1,2023