Identifying biomarkers for high-risk coronary plaques
Risk Evaluation by Coronary Imaging and Artificial Intelligence-Based Functional Analyzing Techniques: Plasma Proteomic Profiles of Atheroma Classified by Intracoronary Imaging.
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 |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06793787 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shanghai, Shanghai Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.