Evaluation on the Effectiveness and Safety of RuiXin-CoronaryAI for Diagnosis of Coronary Artery Stenosis

Coronary Artery Disease Clinical Trial

Official title:

Evaluation on the Effectiveness and Safety of AI-based Coronary CT Angiographic Analysis Software (RuiXin-CoronaryAI) for Diagnosis of Coronary Artery Stenosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05320185
• Other study ID #: RuiXin-CoronaryAI
• Status: Recruiting
• Start date: July 28, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: March 2022
• Source: Shenzhen Raysight Intelligent Medical Technology Co., Ltd.
• Contact: Liming Xia
• Phone: 13607176908
• Email: lmxia[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 CT scan with ≥64-slices. The subjects with unqualified CTA will be excluded. CCTA images will be analyzed in three methods (3 groups). 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. Primary outcomes are diagnostic sensitivity and specificity of RuiXin-CoronaryAI and coronary CTA for diagnosis of ischemia on a per-vessel basis. The effectiveness of RuiXin-CoronaryAI for diagnosis of coronary artery stenosis will be conducted by testing superiority of diagnostic sensitivity and non-inferiority of specificity.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 615
• Est. completion date: December 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. layer thickness of CCTA images should be less than 1mm, image quality should be up to DICOM 3.0 standards;

2. 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;

3. remodeling of vessels should be intact, including coronary artery and branches, without missed or inaccurate slices;

4. CCTA image should be obtained from single- or dual-source computed tomography (CT) scanners with a minimum of 64 detector rows.

Exclusion Criteria:

1. 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;

2. previous percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG);

3. anomalous origin of coronary artery;

4. other non-atherosclerosis-related coronary diseases like coronary artery fistula, aneurysm, coronary artery ectasia, arteritis coronaria, etc.;

5. repeated enrollment;

6. other conditions not suitable for enrollment.

Related Conditions & MeSH terms

• Artificial Intelligence
• Constriction, Pathologic
• Coronary Artery Disease
• Coronary Artery Stenosis
• Coronary Stenosis
• CT Angiography

Intervention

Device:
• RuiXin-CoronaryAI software
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).

Locations

Country	Name	City	State
China	Beijing Hospital	Beijing	Beijing
China	Sun Yat-sen Memorial Hospital	Guangzhou	Guangdong
China	Tongji Hospital	Wuhan	Hubei

Sponsors (4)

Lead Sponsor	Collaborator
Shenzhen Raysight Intelligent Medical Technology Co., Ltd.	Beijing Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Per-patient diagnostic sensitivity of RuiXin-CoronaryAI for diagnosis of coronary artery stenosis	Outcome measures were comparing RuiXin-CoronaryAI to CTA on a per-patient 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	Per-patient diagnostic specificity of RuiXin-CoronaryAI for diagnosis of coronary artery stenosis	Outcome measures were comparing RuiXin-CoronaryAI to CTA on a per-patient 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.