Study on Risk Factors and Prognostic Value of Non-target Lesion Progression in Patients With Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,400
- 试验地点
- 1
- 主要终点
- Angiographic Progression of Non-Target Lesions
研究概览
简要总结
The goal of this observational study is to explore the risk factors and prognostic value of non-target coronary lesion progression in patients aged 18-80 years with established coronary artery disease who are scheduled for repeat coronary angiography. The main questions it aims to answer are:
What clinical, inflammatory and metabolic factors are independently associated with the progression of untreated non-target lesions after percutaneous coronary intervention? Does the initial interventional strategy (drug-eluting stent vs. drug-coated balloon) influence the long-term progression of non-target coronary lesions and subsequent clinical outcomes? Researchers will compare participants treated with drug-eluting stents (DES) and those treated with drug-coated balloons (DCB) at their prior index procedure to see if different local interventional modalities lead to differences in non-target lesion progression and major adverse cardiovascular events during follow-up.
Participants will:
Undergo clinically indicated repeat coronary angiography, with offline quantitative coronary angiography (QCA) analysis of all coronary segments Provide baseline clinical data, medical history and blood samples for inflammatory and metabolic biomarker testing Complete 3 years of regular clinical follow-up to track lesion evolution and cardiovascular endpoints
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible for enrollment in this study, participants must meet all of the following criteria:
- •Aged 18 to 80 years, regardless of gender, with full decision-making capacity; Previously diagnosed with coronary artery disease (coronary artery diameter stenosis ≥ 50%) by coronary angiography, and scheduled to undergo repeat coronary angiography; Able to provide written informed consent.
排除标准
- •Participants will be excluded from the study if they meet any of the following criteria:
- •Undergoing coronary artery bypass grafting (CABG) during the index hospitalization; Poor angiographic image quality (vessel overlap, inadequate opacification) that precludes quantitative coronary angiography (QCA) or Angio FFR analysis; Concomitant severe valvular heart disease, cardiomyopathy, or active infection.
研究组 & 干预措施
Progression group、Non-progression group
干预措施: Progression of non-target vessels (Other)
结局指标
主要结局
Angiographic Progression of Non-Target Lesions
时间窗: From baseline interventional procedure to follow-up coronary angiography (median follow-up duration of approximately 12 to 24 months, subject to the timing of routine clinical follow-up angiography); lesion progression-related events will be continuously
Quantitative coronary angiography (QCA) will be performed to compare coronary angiographic images obtained at baseline (during the initial percutaneous coronary intervention) and during follow-up. All non-target coronary segments that did not receive initial interventional treatment will be quantitatively measured for luminal diameter stenosis to assess the progression of atherosclerotic lesions. Non-target lesion progression is defined as meeting any of the following criteria: an absolute increase of ≥20% in luminal diameter stenosis in the same non-target segment at follow-up angiography compared with baseline; progression from baseline diameter stenosis \<50% to clinically significant stenosis with diameter stenosis ≥50%; or new-onset atherosclerotic lesions with diameter stenosis ≥50% in non-target segments during follow-up. Based on this endpoint, clinical, inflammatory and metabolic risk factors associated with non-target lesion progression will be analyzed, and the incidence of
次要结局
未报告次要终点