A CCTA Image Assisted Triage Software for the Assessment of Patients With Suspected Coronary Artery Disease: a Retrospective, Multi-center, Blind-evaluation Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,093
- 试验地点
- 5
- 主要终点
- Sensitivity and specificity of experiment group in triage for patients with suspected coronary artery disease
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Sensitivity and specificity of experiment group in triage for patients with suspected coronary artery disease
时间窗: 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.
次要结局
- Diagnostic time(October 13,2022 to March 1,2023)
- Patient as research unit(October 13,2022 to March 1,2023)
- Blood vessels were used as the research unit(October 13,2022 to March 1,2023)
- The vascular segment was used as the research unit(October 13,2022 to March 1,2023)
- Gender stratified statistics, respectively, with patients and blood vessels as research units(October 13,2022 to March 1,2023)
- Software performance evaluation(October 13,2022 to March 1,2023)
- Manufacturer stratified statistics, respectively, with patients and blood vessels as research units(October 13,2022 to March 1,2023)
- Row number stratified statistics, respectively, with patients and blood vessels as research units(October 13,2022 to March 1,2023)
- The stratified statistics of tube voltage were conducted with patients and blood vessels as research units(October 13,2022 to March 1,2023)
- Layer thickness stratified statistics, patients and blood vessels were used as research units(October 13,2022 to March 1,2023)
- The patients and blood vessels were selected as the research units(October 13,2022 to March 1,2023)
- Post-processing image quality evaluation(October 13,2022 to March 1,2023)