Status:
UNKNOWN
Evaluation on the Effectiveness and Safety of RuiXin-CoronaryAI for Diagnosis of Coronary Artery Stenosis
Lead Sponsor:
Shenzhen Raysight Intelligent Medical Technology Co., Ltd.
Collaborating Sponsors:
Tongji Hospital
Beijing Hospital
Conditions:
Coronary Artery Disease
Artificial Intelligence
Eligibility:
All Genders
18+ years
Brief Summary
With the emergence of advanced technology to date in the artificial intelligence (AI), computer aided diagnosis has gradually gained its popularity in the field of healthcare. Particularly, in the cli...
Detailed Description
Patients ≥18 years old with suspected or known coronary artery disease who underwent CCTA will be included. CCTA images of subjects should be of good quality up to the DICOM 3.0 standards, obtained by...
Eligibility Criteria
Inclusion
- layer thickness of CCTA images should be less than 1mm, image quality should be up to DICOM 3.0 standards;
- vessels should be clearly developed, contrast medium ought to be well filled, the average of CT value of aortic root cavity should be between 325-600HU in CCTA image;
- remodeling of vessels should be intact, including coronary artery and branches, without missed or inaccurate slices;
- CCTA image should be obtained from single- or dual-source computed tomography (CT) scanners with a minimum of 64 detector rows.
Exclusion
- CCTA image is of poor quality due to motion artifact, severe calcification, metal coverage, noise, poor contrast medium injection and other variables influencing the diagnosis of stenosis;
- previous percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG);
- anomalous origin of coronary artery;
- other non-atherosclerosis-related coronary diseases like coronary artery fistula, aneurysm, coronary artery ectasia, arteritis coronaria, etc.;
- repeated enrollment;
- other conditions not suitable for enrollment.
Key Trial Info
Start Date :
July 28 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2022
Estimated Enrollment :
615 Patients enrolled
Trial Details
Trial ID
NCT05320185
Start Date
July 28 2021
End Date
December 30 2022
Last Update
September 21 2022
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing Hospital
Beijing, Beijing Municipality, China, 100730
2
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China, 510120
3
Tongji Hospital
Wuhan, Hubei, China, 430030