Coronary Heart Disease
Conditions
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)
Interventions
OTHERNo intervention
Due to observational study
Sponsors
Keya Medical
Study design
Observational model
CASE_CROSSOVER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. 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 2. CCTA image quality score ≥ 3 (5-point Likert scale).
Exclusion criteria
1. Severe coronary artery calcification, which in the judgment of readers affects the stenosis adjudicator; 2. Previous percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG); 3. Congenital anomalies of coronary artery origin or other malformations; 4. Coronary artery occlusive lesions; 5. Implantation of the pacemaker, internal defibrillator electrode, or prosthetic heart valve.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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. |
| 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. |
| 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. |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Device Defects | October 13,2022 to March 1,2023 | In the course of clinical trials, there are unreasonable risks that may endanger human health and life safety under normal use of medical devices, such as label errors, quality problems, and frequent failures |
Countries
China
Outcome results
None listed