The Role of Pyroptosis in Chronic Venous Disease and Its Pathophysiological Implication
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Pyroptosis evaluation 3
研究概览
简要总结
Enrollment criteria and clinical data collection: following the principles of medical ethics, the development of inclusion and exclusion criteria. Selecting 200 cases of chronic venous disease (CVD) according to the Comprehensive Classification System for Chronic Venous Disorders (CEAP) divided into 6 Clinical stages (C1-C6) (Group A). Selecting 200 healthy participants without CVD (C0) as controls (Group B). Blood samples will be collected from both groups. Markers of pyroptosis (NETs, Caspase-1 and Cytokines) will be evaluated between the two groups and between the subgroups, according to clinical stage, in group A.
详细描述
Pyroptosis is a pro-inflammatory form of regulated cell death and is dependent on networks of extracellular fibers (NET,s), on the enzymatic activity of inflammatory proteases that belong to the family of cysteine-dependent aspartate-specific proteases (caspase), and cytokines. The role of inflammation has been previously demonstrated in chronic venous disease (CVD), which is a condition that affects up to 80% of adult population in western countries.
According to the Comprehensive Classification System for Chronic Venous Disorders (CEAP) divided into 6 Clinical stages:
C0: no visible or palpable signs of venous disease. C1: telangiectasies or reticular veins. C2: varicose veins. C3: edema. C4a: pigmentation and eczema. C4b: lipodermatosclerosis and atrophie blanche. C5: healed venous ulcer. C6: active venous ulcer.
The aim of this study is to evaluate the role of pyroptosis in the onset and progression of CVD.
The Investigators will select 200 participants with chronic venous disease (CVD) according to Clinical stage of CEAP (C1-C6 patients) [Group A] . The investigators will also select 200 healthy participants without CVD (C0) as controls [Group B].
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chronic Venous Disease (C1-C6 CEAP classification )
排除标准
- •Peripheral artery disease
- •Malignant Tumors
- •Severe cardiovascular and cerebrovascular disease
- •Liver and kidney failure
结局指标
主要结局
Pyroptosis evaluation 3
时间窗: 2 years
IL-1 β, IL-4, IL-10, IL-18, and TNF-α evaluation to presented in pg/ml
Pyroptosis evaluation 1
时间窗: 2 years
NETs evaluation to be presented in ng/ml
Pyroptosis evaluation 2
时间窗: 2 years
Caspase-1 evaluation to be presented in pg/ml
次要结局
未报告次要终点
研究者
Prof. Raffaele Serra, MD, Ph.D.
Clinical Professor
University of Catanzaro