Actively Recruiting

Age: 18Years +
All Genders
NCT06793787

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

Led by Ruijin Hospital · Updated on 2025-01-27

200

Participants Needed

1

Research Sites

182 weeks

Total Duration

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AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosed with chronic coronary syndrome (CCS) or non-ST-segment elevation acute coronary syndrome (NSTE-ACS)
  • Underwent coronary CT angiography (CCTA) or invasive coronary angiography (ICA) showing marginal lesions (40%-69% diameter stenosis) or obstructive lesions (70% or more diameter stenosis or CT-FFR/FFR less than 0.8) in major coronary arteries
  • Received invasive coronary angiography and optical coherence tomography (OCT), with or without intravascular ultrasound (IVUS) and near infrared spectroscopy (NIRS) imaging techniques
Not Eligible

You will not qualify if you...

  • Percutaneous coronary intervention (PCI) within the past 6 months
  • History of myocardial infarction or heart failure
  • History of coronary artery bypass graft (CABG)
  • Abnormal liver function (alanine aminotransferase [ALT] over 3 times the normal limit) or abnormal kidney function (eGFR 30% or less)
  • Familial hypercholesterolemia
  • Estimated survival of 1 year or less
  • Malignant tumor
  • Pregnant, breastfeeding, or planning to give birth within one year
  • Poor compliance or inability to complete follow-up

AI-Screening

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Trial Site Locations

Total: 1 location

1

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China, 200025

Actively Recruiting

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Research Team

X

Xiao Qun Wang, M.D.,Ph.D.

CONTACT

S

Shuo Feng, M.D.,Ph.D.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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