A CCTA Image Assisted Triage Software for the Assessment of Patients With Suspected Coronary Artery Disease
- Conditions
- Coronary Heart Disease
- Interventions
- Other: No intervention
- Registration Number
- NCT06172985
- Lead Sponsor
- Keya Medical
- Brief Summary
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
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)
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1093
-
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).
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Suspected patients with coronary heart disease. No intervention 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
- Primary Outcome Measures
Name Time Method Sensitivity and specificity of experiment group in triage for patients with suspected coronary artery disease October 13,2022 to March 1,2023 Based on the results of the independent expert group, uses stenosis degree≥50% as the boundary for triage indication on a per-patient basis.
- Secondary Outcome Measures
Name Time Method Diagnostic time October 13,2022 to March 1,2023 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.
Patient as research unit October 13,2022 to March 1,2023 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.
Blood vessels were used as the research unit October 13,2022 to March 1,2023 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.
The vascular segment was used as the research unit October 13,2022 to March 1,2023 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.
Gender stratified statistics, respectively, with patients and blood vessels as research units October 13,2022 to March 1,2023 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
Software performance evaluation October 13,2022 to March 1,2023 From the function of use, ease of operation, stability to evaluate, divided into satisfactory, general, unsatisfactory three levels.
Manufacturer stratified statistics, respectively, with patients and blood vessels as research units October 13,2022 to March 1,2023 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
Row number stratified statistics, respectively, with patients and blood vessels as research units October 13,2022 to March 1,2023 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
The stratified statistics of tube voltage were conducted with patients and blood vessels as research units October 13,2022 to March 1,2023 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
Layer thickness stratified statistics, patients and blood vessels were used as research units October 13,2022 to March 1,2023 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
The patients and blood vessels were selected as the research units October 13,2022 to March 1,2023 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
Post-processing image quality evaluation October 13,2022 to March 1,2023 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.
Trial Locations
- Locations (5)
The Pearl River Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Affiliated Hospital of Zunyi Medical University
🇨🇳Zunyi, Guizhou, China
Huanggang Central Hospital
🇨🇳Huanggang, Hubei, China
Fuwai Hospital, Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China