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

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

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)

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.