Coronary Artery DiseaseRECOGNIZE-IIINCT06793774
Risk Evaluation by COronary Imaging and Artificial intelliGence Based fuNctIonal analyZing tEchniques - III
An observational study of Coronary Artery Disease and Coronary Atheroscleroses, run by Ruijin Hospital at 1 site in China.
Trial summary
This is a single-center, prospective cohort study. This study is designed to accurately analyze coronary artery plaque characteristics and local hemodynamic parameters in patients diagnosed with chronic coronary syndrome (CCS) or non-ST-segment elevation acute coronary syndrome (NSTE-ACS), with marginal lesions or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Atheroscleroses, Acute Coronary Syndromes (ACS)
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 31 Dec 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: This cohort includes patients with coronary artery disease as detected by computed tomography angiography (CCTA), and was planned to receive coronary angiography.
Who may be able to join
- Age ≥ 18 years
- Patients with CCS or NSTE-ACS
- Receive CCTA scan, with marginal lesions (DS between 40%-69%) or obstructive lesions (DS ≥70% or CT-FFR <0.8) in major coronary arteries
- Receive invasive coronary angiography and intracoronary imaging examination, including IVUS, OCT, NIRS, within 1 month after CCTA
Who cannot join
- Unsuitable for CCTA (such as severe renal impairment, uncontrolled thyroid condition, allergic to iodine, etc.)
- Receive percutaneous coronary intervention (PCI) within 6 months
- Prior history of myocardial infarction or heart failure
- Prior history of coronary artery bypass graft (CABG)
- Abnormal liver function (serum alanine aminotransferase [ALT] level exceeding 3 times the upper limit of normal) or abnormal kidney function (eGFR ≤30%)
- Familial hypercholesterolemia
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- Estimated survival ≤ 1 year
- Malignant tumor
- Pregnant or lactation, or have the intention to give birth within one year
- Poor compliance, unable to follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Jian Li, BS, 0086 021 64370045, ruijincrc@126.com
Ruiyan Zhang, M.D., Ph.D.
About this study
Official title: Risk Evaluation by Coronary Imaging and Artificial Intelligence-Based Functional Analyzing Techniques: Integrated Plaque Analysis by Coronary CT Angiography and Intracoronary Imaging.
This is a single-center, prospective cohort study. This study is designed to accurately analyze coronary artery plaque characteristics and local hemodynamic parameters in patients diagnosed with chronic coronary syndrome (CCS) or non-ST-segment elevation acute coronary syndrome (NSTE-ACS), with marginal lesions or obstructive lesions in major coronary arteries by multimodality imaging including noninvasive coronary CT angiography (CCTA) and intracoronary imaging techniques, such as intravascular ultrasound (IVUS), optical coherence tomography (OCT), and near infrared spectroscopy (NIRS). The purpose of this study is to improve the accuracy and depth of plaque analysis by CCTA under the guidance of intracoronary imaging, therefore constructing a new CCTA-based high-risk plaque model.
Read the detailed description
This is a single-center, prospective cohort study. This study is designed to accurately analyze coronary artery plaque characteristics and local hemodynamic parameters in patients diagnosed with chronic coronary syndrome (CCS) or non-ST-segment elevation acute coronary syndrome (NSTE-ACS), with marginal lesions (diameter stenosis [DS] between 40%-69%) or obstructive lesions (DS ≥70% or CT-FFR <0.8) in major coronary arteries by multimodality imaging including noninvasive coronary CT angiography (CCTA) and intracoronary imaging techniques, such as intravascular ultrasound (IVUS), optical coherence tomography (OCT), and near infrared spectroscopy (NIRS). The congruity and incongruity between different imaging modalities will be evaluated.
The purpose of this study is to improve the accuracy and depth of plaque analysis by CCTA under the guidance of intracoronary imaging by co-registration, feature extraction, radiomic analysis and machine learning. Afterwards, a new CCTA-based high-risk plaque model will be constructed through the training process guided by intracoronary imaging and hemodynamic evaluation.
The cohort will be followed-up every 3 months for 2 years. Cross-validation will be performed to compare the new model with traditional CTA models in detecting high-risk plaques and predicting the occurrence of major adverse cardiovascular events (MACEs). All the patients with CCS or NSTE-ACS, who undergo CCTA to confirm the presence of marginal or obstructive coronary lesions, and the subsequent invasive coronary angiography and intracoronary imaging examination within 1 month after CCTA will be enrolled.
- Keywords
- coronary CT angiography, intracoronary imaging, coronary optical coherence tomography
- Medical subject headings
- Coronary Artery Disease, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study cohort | Patients with CCS or NSTE-ACS, who receive CCTA scan showing marginal or obstructive lesions (DS 40%-90%), are then referred to invasive coronary angiography with intracoronary imaging examination, such as IVUS, OCT, NIRS, within 1 month |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction performance of high-risk plaques by CCTA
By using intracoronary imaging as the 'gold standard', the new CCTA model generated by machine learning will be compared with traditional CCTA models in the prediction performance of high-risk plaques (area under receiver operating characteristics curve, etc.)
Measured: 2 Years
Secondary outcomes (4)
Major cardiovascular events (MACEs)
A composite endpoint of cardiovascular death, non-fatal myocardial infarction, and unplanned revascularization during follow-up. The prediction performance of MACEs by the new model and traditional CCTA models will be compared
Measured: 2 years
Cardiovascular death
The occurrence of cardiovascular death during follow-up. The prediction performance of cardiovascular death by the new model and traditional CCTA models will be compared.
Measured: 2 years
Myocardial infarction
The occurrence of myocardial infarction during follow-up. The prediction performance of myocardial infarction by the new model and traditional CCTA models will be compared.
Measured: 2 years
Unplanned revascularization
The occurrence of unplanned revascularization during follow-up. The prediction performance of unplanned revascularization by the new model and traditional CCTA models will be compared.
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 posted27 Jan 2025
- Study start1 Jul 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2027 (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
- 300 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., Study director, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793774
- Sponsor's protocol ID
- 2022YFC2533502-3
- Acronym
- RECOGNIZE-III
- Status last verified
- Jan 2025
- First submitted
- 21 Jan 2025
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Evaluation by Coronary Imaging and Artificial Intelligence-Based Functional Analyzing Techniques: Integrated Plaque Analysis by Coronary CT Angiography and Intracoronary Imaging.
- ClinicalTrials.gov ID
- NCT06793774
- Acronym / sponsor ID
- RECOGNIZE-III / 2022YFC2533502-3
- Keywords
- coronary CT angiography, intracoronary imaging, coronary optical coherence tomography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Jan 2025 (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 is a single-center, prospective cohort study. This study is designed to accurately analyze coronary artery plaque characteristics and local hemodynamic parameters in patients diagnosed with chronic coronary syndrome (CCS) or non-ST-segment elevation acute coronary syndrome (NSTE-ACS), with marginal lesions or obstructive lesions in major coronary arteries by multimodality imaging including noninvasive coronary CT angiography (CCTA) and intracoronary imaging techniques, such as intravascular ultrasound (IVUS), optical coherence tomography (OCT), and near infrared spectroscopy (NIRS). The purpose of this study is to improve the accuracy and depth of plaque analysis by CCTA under the guidance of intracoronary imaging, therefore constructing a new CCTA-based high-risk plaque model.
Detailed description
This is a single-center, prospective cohort study. This study is designed to accurately analyze coronary artery plaque characteristics and local hemodynamic parameters in patients diagnosed with chronic coronary syndrome (CCS) or non-ST-segment elevation acute coronary syndrome (NSTE-ACS), with marginal lesions (diameter stenosis [DS] between 40%-69%) or obstructive lesions (DS ≥70% or CT-FFR <0.8) in major coronary arteries by multimodality imaging including noninvasive coronary CT angiography (CCTA) and intracoronary imaging techniques, such as intravascular ultrasound (IVUS), optical coherence tomography (OCT), and near infrared spectroscopy (NIRS). The congruity and incongruity between different imaging modalities will be evaluated.
The purpose of this study is to improve the accuracy and depth of plaque analysis by CCTA under the guidance of intracoronary imaging by co-registration, feature extraction, radiomic analysis and machine learning. Afterwards, a new CCTA-based high-risk plaque model will be constructed through the training process guided by intracoronary imaging and hemodynamic evaluation.
The cohort will be followed-up every 3 months for 2 years. Cross-validation will be performed to compare the new model with traditional CTA models in detecting high-risk plaques and predicting the occurrence of major adverse cardiovascular events (MACEs). All the patients with CCS or NSTE-ACS, who undergo CCTA to confirm the presence of marginal or obstructive coronary lesions, and the subsequent invasive coronary angiography and intracoronary imaging examination within 1 month after CCTA will be enrolled.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study cohort | – | –Patients with CCS or NSTE-ACS, who receive CCTA scan showing marginal or obstructive lesions (DS 40%-90%), are then referred to invasive coronary angiography with intracoronary imaging examination, such as IVUS, OCT, NIRS, within 1 month |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This cohort includes patients with coronary artery disease as detected by computed tomography angiography (CCTA), and was planned to receive coronary angiography.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Patients with CCS or NSTE-ACS
- Receive CCTA scan, with marginal lesions (DS between 40%-69%) or obstructive lesions (DS ≥70% or CT-FFR <0.8) in major coronary arteries
- Receive invasive coronary angiography and intracoronary imaging examination, including IVUS, OCT, NIRS, within 1 month after CCTA
Key exclusion criteria (10 listed)
- Unsuitable for CCTA (such as severe renal impairment, uncontrolled thyroid condition, allergic to iodine, etc.)
- Receive percutaneous coronary intervention (PCI) within 6 months
- Prior history of myocardial infarction or heart failure
- Prior history of coronary artery bypass graft (CABG)
- Abnormal liver function (serum alanine aminotransferase [ALT] level exceeding 3 times the upper limit of normal) or abnormal kidney function (eGFR ≤30%)
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
Prediction performance of high-risk plaques by CCTA
Time frame: 2 Years
By using intracoronary imaging as the 'gold standard', the new CCTA model generated by machine learning will be compared with traditional CCTA models in the prediction performance of high-risk plaques (area under receiver operating characteristics curve, etc.)
4 secondary outcomes
Major cardiovascular events (MACEs)
Time frame: 2 years
Cardiovascular death
Time frame: 2 years
Myocardial infarction
Time frame: 2 years
Unplanned revascularization
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- 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.
Ruiyan Zhang, M.D., Ph.D. study director
Ruijin Hospital
1 site 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 Coronary Atheroscleroses, run by Ruijin Hospital at 1 site 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 10 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: looking for participants now, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoqun Wang, M.D., Ph.D. (+86 21 64370045 ext. 671605, xiaoqun_wang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction performance of high-risk plaques by CCTA (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 27 Jan 2025.