About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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%)
Trial population
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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Prediction performance of high-risk plaques by novel biomarkers
The prediction performance of high-risk plaques (area under receiver operating characteristics curve, etc.) by novel biomarkers will be compared with traditional risk factors.
Secondary outcomes
Major cardiovascular events (MACEs)
A composite endpoint of cardiovascular death, non-fatal myocardial infarction, and unplanned revascularization during follow-up. The prediction performance of MACEs by novel biomarkers and traditional risk factors will be compared.
Cardiovascular death
The occurrence of cardiovascular death during follow-up. The prediction performance of cardiovascular death by novel biomarkers and traditional risk factors will be compared.
Myocardial infarction
The occurrence of myocardial infarction during follow-up. The prediction performance of myocardial infarction by novel biomarkers and traditional risk factors will be compared.
Unplanned revascularization
The occurrence of unplanned revascularization during follow-up. The prediction performance of novel biomarkers and traditional risk factors will be compared.
Sponsors and contacts
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