Status:
UNKNOWN
A CCTA Image Assisted Triage Software for the Assessment of Patients With Suspected Coronary Artery Disease
Lead Sponsor:
Keya Medical
Conditions:
Coronary Heart Disease
Eligibility:
All Genders
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 suspecte...
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 ...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
May 9 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 29 2024
Estimated Enrollment :
1093 Patients enrolled
Trial Details
Trial ID
NCT06172985
Start Date
May 9 2023
End Date
February 29 2024
Last Update
December 15 2023
Active Locations (5)
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1
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
2
The Pearl River Hospital of Southern Medical University
Guangzhou, Guangdong, China
3
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China
4
The First Affiliated Hospital of Hebei Medical University
Shijiazhuang, Hebei, China