No intervention: This is an observational study. No specific interventions are administered by the research team. Participants receive standard diagnostic and therapeutic procedures as per routine clinical practice. The study involves retrospective analysis of existing medical records (CCTA and ICA data) to evaluate the association between AI-derived metrics and clinical outcomes.
Study summary
This multicenter, retrospective registry study aims to evaluate the value of artificial intelligence (AI)-derived coronary CT angiography (CCTA) parameters in predicting long-term cardiovascular events in patients with coronary artery disease (CAD). We plan to enroll 3,000 patients from five tertiary hospitals who underwent both CCTA and invasive coronary angiography (ICA) within 90 days. Using ICA and quantitative flow ratio (QFR) as reference standards, we will compare the diagnostic performance of different commercial AI software platforms. Furthermore, we will investigate the association between AI-extracted CCTA multidimensional parameters-including high-risk plaque features, CT-derived fractional flow reserve (CT-FFR), and pericoronary fat attenuation index (FAI)-and major adverse cardiac events (MACE) during over one year of follow-up. We will also explore how lipid-lowering therapies, antiplatelet regimens, and inflammatory biomarkers modify these predictive relationships. This study is expected to provide imaging evidence for personalized risk stratification and optimized clinical decision-making in CAD management.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥18 years at the time of index coronary CT angiography (CCTA).
2. Clinically suspected or confirmed coronary artery disease (CAD).
3. Underwent both CCTA and invasive coronary angiography (ICA) within 90 days.
4. Availability of clinical follow-up data for at least 12 months after the index CCTA.
5. Sufficient image quality of CCTA and ICA to allow AI-based analysis and quantitative assessment.
6. Signed informed consent or waiver of informed consent approved by the Institutional Review Board (IRB).
Exclusion Criteria:
1. Age \<18 years.
2. Poor CCTA image quality precluding reliable AI analysis (e.g., severe motion artifacts, inadequate contrast opacification).
3. History of prior coronary artery bypass grafting (CABG).
4. Follow-up duration \<12 months or incomplete follow-up records.
5. Known hypersensitivity to iodinated contrast media, hyperthyroidism, severe hepatic or renal dysfunction (eGFR \<30 mL/min/1.73m²), or malignancy.
6. Pregnancy or lactation at the time of CCTA.
7. Incomplete or missing core baseline data (e.g., lack of CCTA/ICA images, key clinical variables, or lipid profiles).
Primary outcome measure(s)
Incidence of Major Adverse Cardiac Events (MACE) at 2 years — 2 years MACE is defined as a composite endpoint including cardiac death, recurrent myocardial infarction, unplanned ischemia-driven revascularization (PCI or CABG), and hospitalization for unstable angina or acute heart failure. The incidence will be calculated as the proportion of participants experiencing at least one MACE event within 24 months after the index CCTA examination. All events will be independently adjudicated by two experienced cardiologists based on original medical records.
Trial sites (1)
Facility
City
Region
Status
Nanjing First Hospital, Nanjing Medical University
Nanjing
Jiangsu
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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