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

Risk Evaluation by Coronary Imaging and Artificial Intelligence-Based Functional Analyzing Techniques: Plasma Proteomic Profiles of Atheroma Classified by Intracoronary Imaging.

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.

Study Overview

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

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Xiao Qun Wang, M.D.,Ph.D.; Phone Number: 671605 +86 21 64370045; Email: xiaoqun_wang@hotmail.com
• Study Contact Backup: Name: Shuo Feng, M.D.,Ph.D.; Phone Number: 671605 +86 21 64370045; Email: fengshuorv@hotmail.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
      • Contact: Jian Li, BS; Phone Number: 0086 021 64370045; Email: ruijincrc@126.com
      • Principal Investigator: Ruiyan Zhang, M.D., Ph.D.
      • Sub-Investigator: Xiaoqun Wang, M.D., Ph.D.
      • Sub-Investigator: Shuo Feng, M.D.,Ph,D,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Cornary plaque analysis group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years
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.	2 years
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.	2 years
Unplanned revascularization	The occurrence of unplanned revascularization during follow-up. The prediction performance of novel biomarkers and traditional risk factors will be compared.	2 years

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Investigators: Study Director: Ruiyan Zhang, M.D.,Ph.D., Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: January 21, 2025
• First Submitted That Met QC Criteria: January 21, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 21, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Acute coronary syndrome; coronary CT angiography; Chronic coronary syndrome; intracoronary imaging; Coronary vulnerable plaque
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Disease; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Syndrome; Coronary Artery Disease; Myocardial Ischemia; Atherosclerosis; Acute Coronary Syndrome
• Other Study ID Numbers: 2022YFC2533502-4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No