Actively Recruiting

Age: 18Years +
All Genders
ID06793774

Risk Evaluation by Coronary Imaging and Artificial Intelligence-Based Functional Analyzing Techniques: Integrated Plaque Analysis by Coronary CT Angiography and Intracoronary Imaging.

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

300

Participants Needed

1

Research Sites

104 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are studying patients with chronic coronary syndrome (CCS) or non-ST-segment elevation acute coronary syndrome (NSTE-ACS) to better understand coronary artery plaque characteristics and local blood flow. The study focuses on those with marginal or obstructive lesions in major coronary arteries. By combining 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 improve plaque analysis accuracy and develop a new model to identify high-risk plaques using artificial intelligence and imaging data. Participants undergo a CCTA scan to detect marginal or obstructive coronary lesions, followed within one month by invasive coronary angiography and intracoronary imaging examinations such as IVUS, OCT, and NIRS. The study uses advanced techniques like co-registration, feature extraction, radiomic analysis, and machine learning to compare imaging results and train a new CCTA-based high-risk plaque model. This prospective cohort study is conducted at a single center and includes ongoing monitoring and follow-up. During the study, patients are followed every three months for two years to track cardiovascular events and outcomes. Researchers will evaluate how well the new model predicts high-risk plaques compared to traditional CCTA models, focusing on major adverse cardiovascular events (MACEs) such as cardiovascular death, myocardial infarction, and unplanned revascularization. The study involves detailed imaging assessments and long-term follow-up to improve understanding of coronary artery disease and its risks.

CONDITIONS

Brief 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 18 years or older
  • Diagnosed with chronic coronary syndrome (CCS) or non-ST-segment elevation acute coronary syndrome (NSTE-ACS)
  • Have marginal lesions (40%-69% diameter stenosis) or obstructive lesions (70% or greater diameter stenosis or CT-FFR less than 0.8) in major coronary arteries detected by CCTA
  • Undergo 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 (such as severe kidney problems, uncontrolled thyroid condition, or iodine allergy)
  • Had percutaneous coronary intervention (PCI) within the past 6 months
  • History of myocardial infarction or heart failure
  • History of coronary artery bypass graft surgery (CABG)
  • Abnormal liver function (ALT more than 3 times normal) or kidney function (eGFR 30% or less)
  • Familial hypercholesterolemia
  • Estimated survival of 1 year or less
  • Have a malignant tumor
  • Pregnant, breastfeeding, or planning pregnancy within one year
  • Poor compliance or unable to attend follow-up visits

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for coronary CT angiography (CCTA) to detect coronary artery lesions

Diagnostic Evaluation

Duration - Within 1 month after CCTA

Participants undergo invasive coronary angiography and intracoronary imaging examinations, including intravascular ultrasound (IVUS), optical coherence tomography (OCT), and near infrared spectroscopy (NIRS) to analyze coronary artery plaque characteristics.

1 to 2 visits depending on imaging procedures

Long-term Monitoring

Duration - 2 years

Participants are followed up every 3 months for 2 years to monitor coronary artery plaque progression and major adverse cardiovascular events (MACEs).

Quarterly visits every 3 months for up to 2 years

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

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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