An observational study in Coronary Artery Disease, Coronary Atheroscleroses and Acute Coronary Syndromes (ACS), sponsored by Ruijin Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-27.
Sponsored by Ruijin Hospital · Observational
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.
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 300 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.
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This cohort includes patients with coronary artery disease as detected by computed tomography angiography (CCTA), and was planned to receive coronary angiography.
Exclusion Criteria:
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
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.)
Time frame: 2 Years
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 2 years
Plan to share: Undecided
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