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

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Coronary Artery Disease; Chronic Coronary Syndrome; Acute Coronary Syndromes (ACS); Coronary Atheroscleroses

Study type: Observational

Funder types: Other

Identifiers

NCT06793787

2022YFC2533502-4

Details and patient eligibility

About

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.

Full description

This study is a single-center, prospective cohort study. The study is designed to identify novel circulating biomarkers for early prediction of high-risk plaques. 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. Optical coherence tomography (OCT), with or without other intracoronary imaging modalities including intravascular ultrasound (IVUS) and near infrared spectroscopy (NIRS), will be performed to precisely measure plaque burden and other geometric parameters.

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Cornary plaque analysis group

Description:

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.