Identifying biomarkers for high-risk coronary plaques
Official title: Risk Evaluation by Coronary Imaging and Artificial Intelligence-Based Functional Analyzing Techniques: Plasma Proteomic Profiles of Atheroma Classified by Intracoronary Imaging.
Run by Ruijin Hospital · NCT06793787 · Data updated 2026-11-12
This study is trying to find new blood markers that can help predict dangerous heart plaque in patients with chronic heart issues or certain types of heart attacks.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Ruijin Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | July 1, 2024 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2027 |
| Registry record updated | January 27, 2025 |
| Trial ID | NCT06793787 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older diagnosed with chronic coronary syndrome or non-ST-segment elevation acute coronary syndrome who have specific coronary artery lesions.
✕Probably not a fit
Patients who have undergone recent coronary interventions, have a history of significant heart conditions, or have severe liver or kidney dysfunction may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to identify novel circulating biomarkers that can predict high-risk coronary plaques in patients with chronic coronary syndrome or non-ST-segment elevation acute coronary syndrome. Patients will undergo noninvasive coronary CT angiography or invasive coronary angiography to detect lesions, followed by optical coherence tomography and potentially other imaging techniques to assess plaque characteristics. The study will utilize advanced methods like liquid chromatography-mass spectrometry and machine learning to analyze plasma proteomic profiles and their association with major adverse cardiovascular events over a two-year follow-up period.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection and better management of high-risk coronary plaques, potentially reducing the incidence of major cardiovascular events.
How similar studies have gone: While the approach of using advanced imaging and biomarker analysis is promising, the specific combination of techniques in this study is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Xiao Qun Wang, M.D.,Ph.D.
- Email: xiaoqun_wang@hotmail.com
- Phone: +86 21 64370045
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.