Evaluation on the Effectiveness and Safety of RuiXin-CoronaryAI for Diagnosis of Coronary Artery Stenosis
1 other identifier
observational
615
1 country
3
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 clinical practice of coronary artery disease diagnosis, the application of AI could be of great implication in alleviating the shortage of medical sources. To evaluate the effectiveness and safety of the AI-based coronary CT angiographic analysis software (RuiXin-CoronaryAI) for diagnosis of coronary artery stenosis, a retrospective, multi-center, cross-over designed, blinded, sensitivity superiority and specificity non-inferiority clinical trial will be conducted.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2021
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 28, 2021
CompletedFirst Submitted
Initial submission to the registry
March 16, 2022
CompletedFirst Posted
Study publicly available on registry
April 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedSeptember 21, 2022
March 1, 2022
1 year
March 16, 2022
September 19, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Per-vessel diagnostic sensitivity of RuiXin-CoronaryAI for diagnosis of coronary artery stenosis
Outcome measures were comparing RuiXin-CoronaryAI to CTA on a per-vessel basis
1 day; Incident time for CTA examination was dependent on the length of time on the CT scaner. RuiXin-CoronaryAI examination was done remotely at Raysight's processing center in Shenzhen with a turnaround time of 24 hours from CT scan.
Per-vessel diagnostic specificity of RuiXin-CoronaryAI for diagnosis of coronary artery stenosis
Outcome measures were comparing RuiXin-CoronaryAI to CTA on a per-vessel basis
1 day; Incident time for CTA examination was dependent on the length of time on the CT scaner. RuiXin-CoronaryAI examination was done remotely at Raysight's processing center in Shenzhen with a turnaround time of 24 hours from CT scan.
Secondary Outcomes (2)
Per-patient diagnostic sensitivity of RuiXin-CoronaryAI for diagnosis of coronary artery stenosis
1 day; Incident time for CTA examination was dependent on the length of time on the CT scaner. RuiXin-CoronaryAI examination was done remotely at Raysight's processing center in Shenzhen with a turnaround time of 24 hours from CT scan.
Per-patient diagnostic specificity of RuiXin-CoronaryAI for diagnosis of coronary artery stenosis
1 day; Incident time for CTA examination was dependent on the length of time on the CT scaner. RuiXin-CoronaryAI examination was done remotely at Raysight's processing center in Shenzhen with a turnaround time of 24 hours from CT scan.
Study Arms (3)
Control group
CCTA images will be visually evaluated by physicians.
Experiment group
CCTA images will be evaluated by physicians using RuiXin-CoronaryAI.
Reference group
CCTA images will be visually evaluated by cardiologists with at least 10 years experiences, and the conclusions they offer will be used as golden standard.
Interventions
RuiXin-CoronaryAI, based on Computed Tomography Angiography (CTA) and was independently designed by RaysightMed Inc., which has been already authorized by National Medical Products Administration (NMPA).
Eligibility Criteria
Patients ≥18 years old with suspected or known coronary artery disease who underwent CCTA examination.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shenzhen Raysight Intelligent Medical Technology Co., Ltd.lead
- Tongji Hospitalcollaborator
- Beijing Hospitalcollaborator
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen Universitycollaborator
Study Sites (3)
Beijing Hospital
Beijing, Beijing Municipality, 100730, China
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, 510120, China
Tongji Hospital
Wuhan, Hubei, 430030, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Liming Xia
Tongji Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2022
First Posted
April 11, 2022
Study Start
July 28, 2021
Primary Completion
July 30, 2022
Study Completion
December 30, 2022
Last Updated
September 21, 2022
Record last verified: 2022-03