Actively Recruiting

Age: 18Years +
All Genders
ID06793774

Risk Evaluation by Coronary Imaging and Artificial Intelligence-Based Functional Analysis Integrated Plaque Analysis Using Coronary CT Angiography and Intracoronary Imaging

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

300

Participants Needed

1

Research Sites

182 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are conducting a single-center, prospective study to analyze coronary artery plaque characteristics and local blood flow in patients diagnosed with chronic coronary syndrome (CCS) or non-ST-segment elevation acute coronary syndrome (NSTE-ACS). The study focuses on patients with marginal or obstructive lesions in major coronary arteries, aiming to improve the accuracy of plaque assessment using multiple imaging methods, including coronary CT angiography (CCTA) and intracoronary imaging techniques like intravascular ultrasound (IVUS), optical coherence tomography (OCT), and near infrared spectroscopy (NIRS). The goal is to develop a new CCTA-based model to better identify high-risk plaques. Participants will undergo noninvasive CCTA scans followed by invasive coronary angiography and intracoronary imaging within one month. The study will use advanced methods such as co-registration, feature extraction, radiomic analysis, and machine learning to enhance plaque analysis. The new model will be compared with traditional CTA models to assess its ability to detect high-risk plaques and predict major adverse cardiovascular events. Patients will be followed every three months for two years to monitor outcomes. Researchers will evaluate the agreement between different imaging techniques and track the prediction performance of the new high-risk plaque model over this period. The study includes regular assessments to ensure participant safety and adherence, with the total participation lasting two years.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 218 years
  • Diagnosed with chronic coronary syndrome (CCS) or non-ST-segment elevation acute coronary syndrome (NSTE-ACS)
  • Underwent coronary CT angiography (CCTA) showing marginal lesions (diameter stenosis between 40%-69%) or obstructive lesions (diameter stenosis 270% or CT-FFR <0.8) in major coronary arteries
  • Received invasive coronary angiography and intracoronary imaging (IVUS, OCT, NIRS) within 1 month after CCTA
Not Eligible

You will not qualify if you...

  • Unsuitable for coronary CT angiography (e.g., severe renal impairment, uncontrolled thyroid condition, allergy to iodine)
  • Percutaneous coronary intervention (PCI) within the past 6 months
  • Prior history of myocardial infarction or heart failure
  • Prior history of coronary artery bypass graft (CABG)
  • Abnormal liver function (ALT level exceeding 3 times the upper limit of normal) or abnormal kidney function (eGFR 230%)
  • Familial hypercholesterolemia
  • Estimated survival of 1 year or less
  • Malignant tumor
  • Pregnant, breastfeeding, or planning to become pregnant within one year
  • Poor compliance or inability to 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

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Research Team

X

Xiaoqun Wang, M.D., Ph.D.

S

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

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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