NCT06793787

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

Risk Evaluation by Coronary Imaging and Artificial Intelligence-Based Functional Analyzing Techniques: Plasma Proteomic Profiles of Atheroma Classified by Intracoronary Imaging.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 years. The association of novel biomarkers with the occurrence of major adverse cardiovascular events (MACEs) will be examined.

Detailed description

This study is a single-center, prospective cohort study. The study is designed to identify novel circulating biomarkers for early prediction of high-risk plaques. 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/FFR \<0.8) 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 including intravascular ultrasound (IVUS) and near infrared spectroscopy (NIRS), will be performed to precisely measure plaque burden and other geometric parameters. Under the guidance of OCT, these plaques will be classified into different types (intimal xanthoma, early and late fibroatheroma, thin-cap fibroatheroma \[TCFA\], plaque rupture \[PR\], plaque erosion \[PE\], calcified nodules, healed lesions). If IVUS is additionally performed, total atheroma volume (TAV), percent atheroma volume (PAV), and remodeling index will be calculated. If NIRS is additionally performed, lipid core burden index (LCBI) will be calculated. Integrated analysis will also be performed to investigate the relationship between plaque characteristics obtained from different imaging modalities. Afterwards, liquid chromatography-mass spectrometry (LC-MS/MS), bioinformatic analysis, and machine learning methods will be performed to characterize plasma proteomic profiles in patients with different types of coronary atherosclerotic plaques. Differentially expressed proteins will be analyzed to identify novel biomarkers for high-risk plaques. The cohort will be followed-up every 3 months for 2 years. The association of novel biomarkers with the occurrence of major adverse cardiovascular events (MACEs) will be examined.

Conditions

• Coronary Artery Disease
• Coronary Atheroscleroses
• Acute Coronary Syndromes (ACS)
• Chronic Coronary Syndrome

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-12-31
• Completion: 2027-12-31
• First posted: 2025-01-27
• Last updated: 2025-01-27

Locations

1 site across 1 country: China