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Risk Evaluation by COronary Imaging and Artificial intelliGence Based fuNctIonal analyZing tEchniques - IV

Recruitingn/aAges 18 Years - anyAllRuijin Hospital
NCT06793787 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study is a single-center, prospective cohort study. The study is designed to identify novel circulating biomarkers for early prediction of high-risk coronary plaques. 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 detected by noninvasive coronary CT angiography (CCTA) or invasive coronary angiography (ICA), will be consecutively enrolled. Optical coherence tomography (OCT), with or without other intracoronary imaging modalities such as intravascular ultrasound (IVUS) and near infrared spectroscopy (NIRS), will be performed. Liquid chromatography-mass spectrometry (LC-MS/MS), bioinformatic analysis, and machine learning methods will be performed to characterize plasma proteomic profiles. The cohort will be followed-up every 3 months for 2 ye

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 18 years * Patients with CCS or NSTE-ACS * Receive CCTA scan or ICA, with marginal lesions (DS between 40%-69%) or obstructive lesions (DS ≥70% or CT-FFR/FFR \<0.8) in major coronary arteries * Receive invasive coronary angiography and OCT, with or without other intracoronary imaging techniques such as IVUS and NIRS Exclusion Criteria: * 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
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What it tests

  • Not listed
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Where

1 site
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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