Clinical trial NCT06793774: Risk Evaluation by COronary Imaging and Artificial intelliGence Based fuNctIonal analyZing tEchniques - III
Official title: Risk Evaluation by Coronary Imaging and Artificial Intelligence-Based Functional Analyzing Techniques: Integrated Plaque Analysis by Coronary CT Angiography and Intracoronary Imaging.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Coronary Atheroscleroses
Acute Coronary Syndromes (ACS)
Keywords: coronary CT angiography
intracoronary imaging
coronary optical coherence tomography
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This cohort includes patients with coronary artery disease as detected by computed tomography angiography (CCTA), and was planned to receive coronary angiography.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Prediction performance of high-risk plaques by CCTA
timeFrame: 2 Years
Secondary outcomes:
measure: Major cardiovascular events (MACEs)
timeFrame: 2 years
measure: Cardiovascular death
timeFrame: 2 years
measure: Myocardial infarction
timeFrame: 2 years
measure: Unplanned revascularization
timeFrame: 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Ruiyan Zhang, M.D., Ph.D.
role: STUDY_DIRECTOR
References: