Evaluation of Lectine Pathway in Assessment of Unstable Carotid Plaque
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- lectine pathway of complement activation in carotid plaques
研究概览
简要总结
The study is aimed to investigate the possible role of lectin pathway - an alternative pathway of complement activation - in affecting stability of carotid atherosclerotic plaques and the possible correlations with clinical neurologic features.
详细描述
In addition to the known hemodynamic criteria, instable carotid plaques can be responsible for brain ischemia, therefore is paramount to identify preoperatively possible markers of plaque instability. The study is aimed to investigate the possible role of lectin pathway - an alternative pathway of complement activation - in affecting stability of carotid atherosclerotic plaques and the possible correlations with clinical neurologic features. Study population will include 40 patients with internal carotid artery stenosis >=70% (assessed by echocolordoppler), symptomatic or asymptomatic, surgically treated by endoarterectomy. Removed plaques will be evaluated by histologic exam and immunofluorescence for ficolins 1-2-3 and Mannose Binding Lectin (MBL). Plasma samples will be used for ELISA test of lectin pathway complement activation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergone elective or urgent carotid endoarterectomy (CEA) for internal carotid stenosis >70% (assessed by velocimetric criteria) with or without neurologic symptoms
排除标准
- •recent (<20 days) major/minor stroke with positive CT scan
- •absolute contraindications to surgery (cardiac, respiratory, anesthesiologic risk)
结局指标
主要结局
lectine pathway of complement activation in carotid plaques
时间窗: preoperative
assessment of association between plasmatic levels of complement activators and plaque instability (histologic index). Protein plasma levels will be assessed as optical density. Plaque instability will be quantified by a vulnerability score that combines four different histological parameters according to their quartile distribution (Fumagalli et al., Frontiers Immunology 2017). Their association will be analyzed as odds ratio (95%-CI) by a Fisher test.
次要结局
- focal neurologic symptoms and plasmatic levels of complement activators(preoperative, postoperative day 3, 3 months after surgery)
- focal neurologic symptoms and histologic index of plaque instability(through study completion (average 1 year))
研究者
Angela M.R. Ferrante
Angela M.R. Ferrante MD PhD
Fondazione Policlinico Universitario Agostino Gemelli IRCCS