Potential Impact of Neuroimmune and Autophagic Alterations on the Progression and Severity of Human Atherosclerotic Process
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Characterization of the neuro-modulation of immune system in atherosclerosis
研究概览
简要总结
The hypothesis of this study is that neural regulations of the atherosclerotic plaque, identified in the murine model of atherosclerosis, could also exist in human pathology. The dysregulation status of the autonomic nervous system is typical of several cardiovascular diseases, but the role it exerts in the modulation of important mechanisms at the basis of the atherosclerotic process progression has not been investigated yet. The main aim of this study will be to investigate, in the atherosclerotic plaque, the alterations of inflammatory and immune processes, the neural modulations and the presence of dysregulations of the autophagic process. The investigators will also associate the potential presence of neural modulations of the plaque to its stability/instability, from a clinical-translational point of view. Finally, the investigators aim at providing a solid basis for the development of novel therapeutic strategies, which could reduce the elevated health and welfare costs for the clinical management of cardiovascular pathologies such as atherosclerosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 45 and ≤ 90 years;
- •patients with severe (70-99%) carotid stenosis, diagnosed with color doppler echography or angio-MRI or angiography;
- •written informed consent.
排除标准
- •carotid stenosis <70% at carotid bifurcation or diagnosed with color doppler echography or angio-MRI or angiography;
- •severe neoplasia;
- •participation to other clinical trial, ongoing or terminated less than one month before enrolment in this study.
结局指标
主要结局
Characterization of the neuro-modulation of immune system in atherosclerosis
时间窗: At enrollment
Immunohistochemistry and immunofluorescence of the autonomic nervous and immune systems in the atherosclerotic plaque, and flow cytometry analysis of circulating immune cells.
Characterization of the autophagic process and correlation with neural modulations of the stability/instability plaque
时间窗: At enrollment
Expression of autophagic markers and immunohistochemical analysis of the atherosclerotic plaque.
次要结局
未报告次要终点
研究者
Giuseppe Lembo
Full Professor, MD, PhD
Neuromed IRCCS
