Risk Evaluation by COronary Imaging and Artificial intelliGence Based fuNctIonal analyZing tEchniques - IV
NCT ID: NCT06793787
Last Updated: 2025-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2024-07-01
2027-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cornary plaque analysis group
Patients with CCS or NSTE-ACS, who have marginal or obstructive lesions (DS 40% - 90%) detected by CCTA or ICA, will be consecutively enrolled. OCT, with or without other intracoronary imaging modalities including IVUS and NIRS, will be performed to classify plaque types and precisely measure plaque burden and other geometric parameters. Plasma samples will be collected on the day of angiography in all patients after overnight fasting.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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RUIYAN ZHANG
Director of Cardiology, Director of cardiovascular catherization lab, Principle Investigator Affiliation: Ruijin Hospital
Principal Investigators
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Ruiyan Zhang, M.D.,Ph.D.
Role: STUDY_DIRECTOR
Ruijin Hospital
Locations
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Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022YFC2533502-4
Identifier Type: -
Identifier Source: org_study_id
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