Coronary Artery DiseaseRECOGNIZE-IINCT05856110
Risk Evaluation by COronary CTA and Artificial IntelliGence Based fuNctIonal analyZing tEchniques - II
An observational study of Coronary Artery Disease, run by Ruijin Hospital at 9 sites in China.
Trial summary
This study is a multicenter, prospective clinical cohort study. The study intends to continuously enroll patients with coronary heart disease. All subjects will undergo coronary CTA (followed by anatomic, functional and radiomics analysis), proteomics research as well as clinical follow-up of cardiovascular events. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 2,000 participants
- Where
- 9 sitesChina
- Study dates
- 3 Jul 2023to 31 Dec 2025
- How long will I take part?
- 2 Years
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study is a multi-center cohort study. Patients with clinical angina pectoris and suspected coronary artery disease from nine clinical centers across P.R. China, including outpatient and hospitalized patients, are consecutively enrolled.
Who may be able to join
- Age 18-80 years
- Clinically significant angina pectoris, suspecting coronary artery disease
Who cannot join
- Unsuitable for coronary CTA (such as severe renal impairment, uncontrolled thyroid condition, allergic to iodine, etc.)
- Without a visible plaque (defined as ≥ 30% stenosis) in major coronary arteries in coronary CTA
- Prior history of myocardial infarction or heart failure
- Prior history of percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)
- Severe renal or liver failure
- Familial hypercholesterolemia
Show all 9Show fewer
- Estimated survival ≤1 year
- Malignant tumor
- Poor coordinance, unable to follow-up
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites, 9 recruiting
- Not yet recruiting
Cangzhou Center Hospital
Cangzhou, Hebei
Run Guo, M.D.
- Not yet recruiting
First affiliated hospital of Dalian Medical College
Dalian, Liaoning
Xiaolei Yang, M.D.
- Not yet recruiting
First affiliated hospital of Harbin Medical University
Harbin, Heilongjiang
Lei Liu, M.D.
- Not yet recruiting
First Hospital of Nanjing
Nanjing, Jiangsu
Fei Ye, M.D.
- Not yet recruiting
Xinhua Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Yachen Zhang, M.D.
- Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200025
Jian Li, BS, 0086 021 64370045, ruijincrc@126.com
Ruiyan Zhang, M.D., Ph.D.
- Recruiting
General Hospital of Northern Theater Command
Shenyang, Liaoning
Geng Wang, M.D.
- Not yet recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Techonology
Wuhan, Hubei
Tian Xie, M.D.
- Not yet recruiting
First affiliated hospital of Zhengzhou University
Zhengzhou, Henan
Yingying Zheng, M.D.
About this study
Official title: Coronary Computed Tomography Angiography and Functional Analysis in Risk Stratification of Coronary Artery Disease: A Prospective, Multi-center Cohort Study
This study is a multicenter, prospective clinical cohort study. The study intends to continuously enroll patients with coronary heart disease. All subjects will undergo coronary CTA (followed by anatomic, functional and radiomics analysis), proteomics research as well as clinical follow-up of cardiovascular events. The purpose of this study is to establish a new, non-invasive cardiovascular disease risk stratification system.
Read the detailed description
Coronary angiography has been the gold standard for the diagnosis of coronary heart disease and PCI decision-making. However, the value of CAG in risk stratification is limited due to its invasive nature and lack of ability to evaluate coronary physiology and plaque characteristics, which often leads to over-treatment or under-treatment. In recent years, with the development and improvement of imaging technology, the resolution and diagnostic accuracy of coronary artery CTA have been greatly improved, and the subsequent anatomy and function (non-invasive CT-FFR, etc.) have made the assessment of coronary artery lesion risk multi-dimensional. Comprehensive and accurate coronary artery CTA scan plays a positive role in establishing the appropriate standard for PCI and improving the prognosis of patients. However, the existing problems of coronary artery CTA are insufficient imaging studies, complex image analysis, inconsistent diagnostic criteria, and insufficient clinical evidence. This study is one of the series of clinical studies on the topic of "Risk Evaluation by COronary Computed Tomography and Artificial Intelligence Based fuNctIonal analyZing tEchniques (RECOGNIZE)". The purpose of the study is to evaluate the accuracy of early identification of cardiovascular high-risk groups based on the functional evaluation model based on coronary CTA images through a multi-center, prospective clinical cohort study, so as to establish an early, non-invasive and accurate risk classification of cardiovascular events in coronary heart disease.
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary CTA, CT-FFR, Risk Stratification, Artificial Intelligence
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events
Including cardiovascular death, myocardial infarction, and stroke
Measured: 2 years
Secondary outcomes (4)
Cardiovascular death
Death due to cardiovascular events
Measured: 2 years
Myocardial infarction
Including STEMI and NSTEMI
Measured: 2 years
Stroke
Including ischemic and hemorrhagic stroke
Measured: 2 years
Coronary Revascularization
Including percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start3 Jul 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (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.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RUIYAN ZHANG, Ruijin Hospital
- Investigators
- Ruiyan Zhang, M.D., Ph.D., Principal investigator, Ruijin HospitalLin Lu, M.D., Study chair, Ruijin HospitalFei Ye, M.D., Study chair, First Hospital of NanjingYachen Zhang, M.D., Study chair, Xinhua Hospital, Shanghai Jiaotong University School of MedicineTian Xie, M.D., Study chair, Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyLei Liu, M.D., Study chair, First Affiliated Hospital of Harbin Medical UniversityXiaolei Yang, M.D., Study chair, The First Affiliated Hospital of Dalian Medical UniversityRun Guo, M.D., Study chair, Cangzhou Center Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05856110
- Sponsor's protocol ID
- 2022YFC2533502-2
- Acronym
- RECOGNIZE-II
- Status last verified
- Aug 2023
- First submitted
- 4 May 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Computed Tomography Angiography and Functional Analysis in Risk Stratification of Coronary Artery Disease: A Prospective, Multi-center Cohort Study
- ClinicalTrials.gov ID
- NCT05856110
- Acronym / sponsor ID
- RECOGNIZE-II / 2022YFC2533502-2
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary CTA, CT-FFR, Risk Stratification, Artificial Intelligence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 May 2023 (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.
This study is a multicenter, prospective clinical cohort study. The study intends to continuously enroll patients with coronary heart disease. All subjects will undergo coronary CTA (followed by anatomic, functional and radiomics analysis), proteomics research as well as clinical follow-up of cardiovascular events. The purpose of this study is to establish a new, non-invasive cardiovascular disease risk stratification system.
Detailed description
Coronary angiography has been the gold standard for the diagnosis of coronary heart disease and PCI decision-making. However, the value of CAG in risk stratification is limited due to its invasive nature and lack of ability to evaluate coronary physiology and plaque characteristics, which often leads to over-treatment or under-treatment. In recent years, with the development and improvement of imaging technology, the resolution and diagnostic accuracy of coronary artery CTA have been greatly improved, and the subsequent anatomy and function (non-invasive CT-FFR, etc.) have made the assessment of coronary artery lesion risk multi-dimensional. Comprehensive and accurate coronary artery CTA scan plays a positive role in establishing the appropriate standard for PCI and improving the prognosis of patients. However, the existing problems of coronary artery CTA are insufficient imaging studies, complex image analysis, inconsistent diagnostic criteria, and insufficient clinical evidence. This study is one of the series of clinical studies on the topic of "Risk Evaluation by COronary Computed Tomography and Artificial Intelligence Based fuNctIonal analyZing tEchniques (RECOGNIZE)". The purpose of the study is to evaluate the accuracy of early identification of cardiovascular high-risk groups based on the functional evaluation model based on coronary CTA images through a multi-center, prospective clinical cohort study, so as to establish an early, non-invasive and accurate risk classification of cardiovascular events in coronary heart disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is a multi-center cohort study. Patients with clinical angina pectoris and suspected coronary artery disease from nine clinical centers across P.R. China, including outpatient and hospitalized patients, are consecutively enrolled.
Key inclusion criteria (2 listed)
- Age 18-80 years
- Clinically significant angina pectoris, suspecting coronary artery disease
Key exclusion criteria (9 listed)
- Unsuitable for coronary CTA (such as severe renal impairment, uncontrolled thyroid condition, allergic to iodine, etc.)
- Without a visible plaque (defined as ≥ 30% stenosis) in major coronary arteries in coronary CTA
- Prior history of myocardial infarction or heart failure
- Prior history of percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)
- Severe renal or liver failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major Adverse Cardiovascular Events
Time frame: 2 years
Including cardiovascular death, myocardial infarction, and stroke
4 secondary outcomes
Cardiovascular death
Time frame: 2 years
Myocardial infarction
Time frame: 2 years
Stroke
Time frame: 2 years
Coronary Revascularization
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Individual participant dataSharing planned: Undecided
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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.
Ruiyan Zhang, M.D., Ph.D. principal investigator
Ruijin Hospital
Lin Lu, M.D. study chair
Ruijin Hospital
Fei Ye, M.D. study chair
First Hospital of Nanjing
9 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, run by Ruijin Hospital at 9 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 2 inclusion and 9 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 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 Xiaoqun Wang, M.D., Ph.D. (+86 13651839760, xiaoqun_wang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular Events (time frame: 2 years). 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 8 Aug 2023.