Actively Recruiting
Risk Evaluation by Coronary Imaging and Artificial Intelligence-Based Techniques for Plasma Proteomic Profiles of Atheroma in Coronary Artery Disease
Led by Ruijin Hospital · Updated on 2025-01-27
200
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a single-center, prospective cohort study to identify new blood markers that can predict high-risk coronary plaques early. The study focuses on patients diagnosed with chronic coronary syndrome (CCS) or non-ST-segment elevation acute coronary syndrome (NSTE-ACS) who have marginal or obstructive lesions in major coronary arteries, detected by noninvasive coronary CT angiography (CCTA) or invasive coronary angiography (ICA). The goal is to understand how these novel biomarkers relate to the risk of major adverse cardiovascular events (MACEs). Participants will undergo detailed imaging using optical coherence tomography (OCT), sometimes combined with intravascular ultrasound (IVUS) and near infrared spectroscopy (NIRS), to precisely measure plaque characteristics and classify plaques into types such as thin-cap fibroatheroma or plaque rupture. Blood samples will be analyzed with liquid chromatography-mass spectrometry (LC-MS/MS) and advanced bioinformatics and machine learning techniques to profile plasma proteins and identify biomarkers linked to high-risk plaques. The study involves follow-up visits every 3 months for 2 years to monitor participants and assess the relationship between the identified biomarkers and cardiovascular events. Researchers will collect data on plaque features, blood proteomics, and clinical outcomes to evaluate the prediction performance of these new biomarkers over the two-year period.
CONDITIONS
Official Title
Risk Evaluation by COronary Imaging and Artificial intelliGence Based fuNctIonal analyZing tEchniques - IV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with chronic coronary syndrome (CCS) or non-ST-segment elevation acute coronary syndrome (NSTE-ACS)
- Underwent coronary CT angiography (CCTA) or invasive coronary angiography (ICA) showing marginal lesions (40%-69% diameter stenosis) or obstructive lesions (70% or more diameter stenosis or CT-FFR/FFR less than 0.8) in major coronary arteries
- Received invasive coronary angiography and optical coherence tomography (OCT), with or without intravascular ultrasound (IVUS) and near infrared spectroscopy (NIRS) imaging techniques
You will not qualify if you...
- Percutaneous coronary intervention (PCI) within the past 6 months
- History of myocardial infarction or heart failure
- History of coronary artery bypass graft (CABG)
- Abnormal liver function (alanine aminotransferase [ALT] over 3 times the normal limit) or abnormal kidney function (eGFR 30% or less)
- Familial hypercholesterolemia
- Estimated survival of 1 year or less
- Malignant tumor
- Pregnant, breastfeeding, or planning to give birth within one year
- Poor compliance or inability to complete follow-up
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
X
Xiao Qun Wang, M.D.,Ph.D.
S
Shuo Feng, M.D.,Ph.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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