Actively Recruiting
Risk Evaluation by Coronary Imaging and Artificial Intelligence-Based Functional Analyzing Techniques: Plasma Proteomic Profiles of Atheroma Classified by Intracoronary Imaging.
Led by Ruijin Hospital · Updated on 2025-01-27
200
Participants Needed
1
Research Sites
104 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 circulating biomarkers that can help 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. These plaques will be assessed using advanced imaging techniques to better understand their characteristics and potential risks. Participants will undergo noninvasive coronary CT angiography (CCTA) or invasive coronary angiography (ICA) to detect coronary lesions. Optical coherence tomography (OCT), sometimes combined with intravascular ultrasound (IVUS) and near infrared spectroscopy (NIRS), will be used to classify plaque types and measure plaque burden. Blood samples will be collected after overnight fasting to analyze plasma proteomic profiles using liquid chromatography-mass spectrometry (LC-MS/MS) and machine learning methods. The study will follow participants every 3 months for 2 years to monitor outcomes. During the study, researchers will collect detailed imaging and blood data to link plaque features with novel biomarkers. They will track the occurrence of major adverse cardiovascular events (MACEs), cardiovascular death, myocardial infarction, and unplanned revascularization over the 2-year follow-up. This thorough monitoring aims to improve early detection of high-risk plaques and better understand their impact on heart health.
CONDITIONS
Brief 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
- Diagnosis of chronic coronary syndrome (CCS) or non-ST-segment elevation acute coronary syndrome (NSTE-ACS)
- Undergoing coronary CT angiography (CCTA) or invasive coronary angiography (ICA) showing marginal lesions (40%-69% diameter stenosis) or obstructive lesions (70% or greater diameter stenosis or CT-FFR/FFR less than 0.8) in major coronary arteries
- Undergoing invasive coronary angiography and optical coherence tomography (OCT), with or without intravascular ultrasound (IVUS) and near infrared spectroscopy (NIRS) imaging
You will not qualify if you...
- Percutaneous coronary intervention (PCI) within the previous 6 months
- History of myocardial infarction or heart failure
- History of coronary artery bypass graft surgery (CABG)
- Abnormal liver function (alanine aminotransferase level 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 or breastfeeding, or planning to become pregnant within one year
- Poor compliance or inability to attend follow-up visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 1 day
Participants undergo coronary CT angiography or invasive coronary angiography, followed by optical coherence tomography with or without intravascular ultrasound and near infrared spectroscopy to classify plaque types and measure plaque burden.
1 visit (in-person) on the day of angiography
Duration - 1 day
Blood samples are collected after overnight fasting on the day of angiography for plasma proteomic analysis.
1 visit (in-person) concurrent with angiography visit
Duration - 2 years
Participants are followed every 3 months for 2 years to monitor cardiovascular events and evaluate the association of novel biomarkers with major adverse cardiovascular events.
Quarterly visits every 3 months for 2 years
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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