Multicenter Al-derived CCTA Parameters for Predicting Long-term Cardiovascular Events in Coronary Artery Disease: A Retrospective Registry Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Incidence of Major Adverse Cardiac Events (MACE) at 2 years
研究概览
简要总结
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.
详细描述
Background
Coronary artery disease (CAD) remains the leading cause of global mortality. While coronary computed tomography angiography (CCTA) is a Class I-recommended noninvasive modality for evaluating stable chest pain, its interpretation is often limited by inter-observer variability and physician experience. Although artificial intelligence (AI) assists in automating stenosis quantification and plaque analysis, current evidence lacks large-scale, real-world comparisons between different AI platforms using invasive coronary angiography (ICA) as the gold standard. Additionally, the interplay between CCTA-derived anatomical/functional parameters, systemic inflammation, and pharmacological modifications (e.g., statins, antiplatelet agents) in predicting long-term prognosis remains unclear.
Objectives
This study seeks to: (1) Perform a head-to-head comparison of different commercial AI software in diagnosing obstructive CAD using ICA as the reference; (2) Explore the correlation between AI-derived CCTA parameters (plaque characteristics, CT-FFR, pericoronary fat inflammation) and major adverse cardiac events (MACE); (3) Assess the modifying effects of lipid-lowering intensity, LDL-C attainment, antiplatelet regimens, and inflammatory markers on the prognostic value of CCTA.
Methods
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years at the time of index coronary CT angiography (CCTA).
- •Clinically suspected or confirmed coronary artery disease (CAD).
- •Underwent both CCTA and invasive coronary angiography (ICA) within 90 days.
- •Availability of clinical follow-up data for at least 12 months after the index CCTA.
- •Sufficient image quality of CCTA and ICA to allow AI-based analysis and quantitative assessment.
- •Signed informed consent or waiver of informed consent approved by the Institutional Review Board (IRB).
排除标准
- •Age <18 years.
- •Poor CCTA image quality precluding reliable AI analysis (e.g., severe motion artifacts, inadequate contrast opacification).
- •History of prior coronary artery bypass grafting (CABG).
- •Follow-up duration <12 months or incomplete follow-up records.
- •Known hypersensitivity to iodinated contrast media, hyperthyroidism, severe hepatic or renal dysfunction (eGFR <30 mL/min/1.73m²), or malignancy.
- •Pregnancy or lactation at the time of CCTA.
- •Incomplete or missing core baseline data (e.g., lack of CCTA/ICA images, key clinical variables, or lipid profiles).
结局指标
主要结局
Incidence of Major Adverse Cardiac Events (MACE) at 2 years
时间窗: 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.
次要结局
- All-cause Mortality at 2 Years(2 years)
- Cardiovascular Mortality at 2 Years(2 years)