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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRuijin Hospital

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

Qualifiers

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 design

Treatments tested in this trial

  • Not listed

Trial groups

200 Participants
are grouped into 1 trial group

Sponsors and collaborators