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

Keya Medical

Status: Active, not recruiting

Conditions: Coronary Heart Disease

Treatments: Other: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT06172985

CT-091-2022

Details and patient eligibility

About

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.

Full 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)

Enrollment: 1,093 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

1,093 participants in 1 patient group

Suspected patients with coronary heart disease.

Description:

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

Treatment:

Other: No intervention