Coronary Artery DiseaseNCT05320185
Evaluation on the Effectiveness and Safety of RuiXin-CoronaryAI for Diagnosis of Coronary Artery Stenosis
An observational study of Coronary Artery Disease and Artificial Intelligence, run by Shenzhen Raysight Intelligent Medical Technology Co., Ltd. at 3 sites in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Artificial Intelligence, Coronary Artery Stenosis
- What is being tested?
- RuiXin-CoronaryAI software
- Type of treatment
- Medical device
- How many people
- 615 participants
- Where
- 3 sitesChina
- Study dates
- 28 Jul 2021to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients ≥18 years old with suspected or known coronary artery disease who underwent CCTA examination.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Beijing Hospital
Beijing, Beijing Municipality, 100730
Min Chen
- Recruiting
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, 510120
Jun Shen
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430030
Liming Xia, 13607176908, lmxia@tjh.tjmu.edu.cn
About this study
Official title: Evaluation on the Effectiveness and Safety of AI-based Coronary CT Angiographic Analysis Software (RuiXin-CoronaryAI) for Diagnosis of Coronary Artery Stenosis
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.
Read the 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 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.
- Conditions
- Coronary Artery Disease, Artificial Intelligence, Coronary Artery Stenosis, CT Angiography
- Being tested
- RuiXin-CoronaryAI software
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RuiXin-CoronaryAI softwareDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Control group | CCTA images will be visually evaluated by physicians. | |
| Experiment group | CCTA images will be evaluated by physicians using RuiXin-CoronaryAI. Receives: Device: RuiXin-CoronaryAI software | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Outcome measures were comparing RuiXin-CoronaryAI to CTA on a per-patient basis
Measured: 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
Outcome measures were comparing RuiXin-CoronaryAI to CTA on a per-patient basis
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start28 Jul 2021
- Primary completion30 Jul 2022
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 615 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Raysight Intelligent Medical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tongji Hospital, Beijing Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Responsible party
- Sponsor
- Investigators
- Liming Xia, Study director, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05320185
- Sponsor's protocol ID
- RuiXin-CoronaryAI
- Status last verified
- Mar 2022
- First submitted
- 16 Mar 2022
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation on the Effectiveness and Safety of AI-based Coronary CT Angiographic Analysis Software (RuiXin-CoronaryAI) for Diagnosis of Coronary Artery Stenosis
- ClinicalTrials.gov ID
- NCT05320185
- Acronym / sponsor ID
- RuiXin-CoronaryAI
- Conditions
- Coronary Artery Disease, Artificial Intelligence, Coronary Artery Stenosis, CT Angiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 615 participants (estimated)
- Lead sponsor
- Shenzhen Raysight Intelligent Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Tongji Hospital, Beijing Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 11 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –CCTA images will be visually evaluated by physicians. |
| Experiment group | – | Device: RuiXin-CoronaryAI softwareCCTA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients ≥18 years old with suspected or known coronary artery disease who underwent CCTA examination.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RuiXin-CoronaryAI softwareRuiXin-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). | Device | Experiment group |
Primary outcome
Per-vessel diagnostic sensitivity of RuiXin-CoronaryAI for diagnosis of coronary artery stenosis
Time frame: 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.
Outcome measures were comparing RuiXin-CoronaryAI to CTA on a per-vessel basis
Per-vessel diagnostic specificity of RuiXin-CoronaryAI for diagnosis of coronary artery stenosis
Time frame: 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.
Outcome measures were comparing RuiXin-CoronaryAI to CTA on a per-vessel basis
2 secondary outcomes
Per-patient diagnostic sensitivity of RuiXin-CoronaryAI for diagnosis of coronary artery stenosis
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liming Xia study director
Tongji Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Artificial Intelligence, run by Shenzhen Raysight Intelligent Medical Technology Co., Ltd. at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liming Xia (13607176908, lmxia@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Per-vessel diagnostic sensitivity of RuiXin-CoronaryAI for diagnosis of coronary artery stenosis (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.