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临床试验/NCT07312318
NCT07312318招募中不适用

DeVelopment of an Artificial Intelligence-Driven Dynamic Prediction and Precision Stratification System for Coronary Non-Target LesIon ProgressiON After Percutaneous Coronary Intervention: A Multimodal Data-Enabled Multicenter Cohort Study in China

China-Japan Friendship Hospital1 个研究点 分布在 1 个国家目标入组 12,000 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
12,000
试验地点
1
主要终点
Composite endpoint of NTL progression-related myocardial infarction or revascularization

研究概览

简要总结

Coronary artery disease remains a leading cause of global mortality. Although percutaneous coronary intervention (PCI) improves patient outcomes, the long-term risk of major adverse cardiovascular events (MACE) driven by the progression of non-target lesions (NTLs) remains substantial and continues to increase, while current risk stratification tools remain inadequate for predicting NTL progression. This multicenter cohort study aims to develop an artificial intelligence (AI)-driven system for the dynamic prediction and precision stratification of NTL progression after PCI. Utilizing comprehensive multimodal data from 52,577 Chinese patients-including clinical profiles, multi-omics blood biomarkers, and coronary imaging-the research pursues three primary objectives: (1) to identify and validate 2-3 specific biomarkers for NTL progression risk using multi-omics approaches; (2) to construct an integrated risk assessment and early-warning system by applying machine learning to multimodal data for predicting NTL progression and MACE; and (3) to establish metabolic and imaging-based subtypes to create a precision management system that optimizes secondary prevention strategies by identifying specific high-risk populations. This study is expected to provide a novel tool for accurate identification of high-risk patients and personalized post-PCI management, ultimately aiming to improve long-term prognosis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 years or older;
  • Scheduled for or having undergone PCI;
  • Baseline plasma sample obtainable;
  • Informed consent obtained

排除标准

  • Pregnancy or lactation;
  • Severe hepatic or renal dysfunction;
  • Active autoimmune disease;
  • Missing critical data

结局指标

主要结局

Composite endpoint of NTL progression-related myocardial infarction or revascularization

时间窗: 12 month follow-up

1. NTL progression-related myocardial infarction was defined in accordance with the fourth universal definition of myocardial infarction due to any segment of the nontarget vessel or lesion. 2. NTL progression-related revascularization was defined as revascularization driven by angina or ischemia, either PCI or CABG, of any segment of the nontarget vessel or lesion.

次要结局

  • Qualitative data on NTL progression(12 month follow-up)
  • Quantitative data on NTL progression(12 month follow-up)
  • NTL progression-related myocardial infarction(12 month follow-up)
  • NTL progression-related revascularization(12 month follow-up)

研究者

发起方
China-Japan Friendship Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fang Wang

Associate Professor of Cardiology Department

China-Japan Friendship Hospital

研究点 (1)

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