A Multicenter Observational Cohort Study of VAP-Measured Lipid and Lipoprotein Subfractions and In-Stent Restenosis After Percutaneous Coronary Intervention Across ASCVD Risk Strata
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3,600
- 试验地点
- 1
- 主要终点
- Presence of angiographic in-stent restenosis in the retrospective cross-sectional cohort
研究概览
简要总结
This multicenter observational study investigates whether lipid and lipoprotein subfractions measured by Vertical Auto Profile (VAP) are associated with coronary in-stent restenosis after percutaneous coronary intervention (PCI). The study includes a retrospective cross-sectional component in patients with prior PCI who undergo repeat coronary angiography and a prospective follow-up component in patients undergoing index PCI. Serum samples obtained from routine clinical blood collection will be used for VAP testing without additional blood draws.
详细描述
This is a multicenter observational cohort study designed to evaluate the association between VAP-measured lipid and lipoprotein subfractions and in-stent restenosis (ISR) after PCI across ASCVD risk strata.
The study includes two components.
Retrospective cross-sectional component:
Adults aged 18 years or older with prior successful implantation of second-generation drug-eluting stents who undergo repeat coronary angiography at participating centers will be screened. Eligible participants must have complete clinical data for ASCVD risk assessment, available stored serum samples for VAP testing, and angiographic data sufficient to determine ISR status. ISR is defined as >=50% stenosis in the stent-related lumen at repeat coronary angiography. Secondary outcomes in this component include multiple-lesion ISR and multivessel ISR.
Prospective follow-up component:
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
- 否
入选标准
- •Retrospective cross-sectional component:
- •Age >=18 years
- •Prior successful implantation of second-generation drug-eluting stents
- •Repeat coronary angiography available at a participating center
- •Complete data available for ASCVD risk assessment
- •Stored serum sample available for VAP testing
- •Angiographic data sufficient to determine ISR status
- •Prospective component:
- •Age >=18 years
- •Undergoing index PCI
- •Planned routine follow-up coronary angiography
- •Complete data available for ASCVD risk assessment
- •Serum sample available from routine clinical blood collection
- •Able to provide written informed consent and any required privacy authorization
排除标准
- •Severe hepatic dysfunction (ALT or AST >3 x ULN or Child-Pugh class C)
- •Prior CABG with angioplasty performed in a non-native vessel
- •In-stent restenosis occurring within 1 month after PCI
- •Expected survival <1 year (prospective component)
研究组 & 干预措施
Retrospective Cross-sectional Cohort
Adults aged 18 years or older with prior successful implantation of second-generation drug-eluting stents who undergo repeat coronary angiography, have complete data for ASCVD risk assessment, and have stored serum samples available for VAP testing.
干预措施: No intervention (Other)
Prospective Follow-up Cohort
Adults aged 18 years or older undergoing index PCI who have complete data for ASCVD risk assessment, available serum samples from routine clinical blood collection, and prospective follow-up for repeat coronary angiography or ISR-related clinical outcomes.
干预措施: No intervention (Other)
结局指标
主要结局
Presence of angiographic in-stent restenosis in the retrospective cross-sectional cohort
时间窗: At repeat coronary angiography, more than 6 month after prior PCI
In-stent restenosis is defined as \>=50% luminal stenosis in the stent-related lumen at repeat coronary angiography.
Occurrence of angiographic in-stent restenosis in the prospective cohort
时间窗: At follow-up coronary angiography, up to 12 months after index PCI
In-stent restenosis is defined as \>=50% luminal stenosis in the stent-related lumen at follow-up coronary angiography.
Target lesion revascularization in the prospective cohort
时间窗: Within 12 months after index PCI
Target lesion revascularization related to prior stent restenosis requiring repeat PCI or CABG.
次要结局
- Multiple-lesion in-stent restenosis in the retrospective cross-sectional cohort(At repeat coronary angiography, more than 6 month after prior PCI)
- Multivessel in-stent restenosis in the retrospective cross-sectional cohort(At repeat coronary angiography, more than 6 month after prior PCI)
- ISR-related major adverse cardiovascular events in the prospective cohort(Within 12 months after index PCI)