Russian Registry for Chronic Venous Disease Incidence and Natural Course
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 2
- 主要终点
- Incidence of chronic venous insufficiency
研究概览
简要总结
A prospective cohort study of patients with primary varicose veins to assess the morbidity, risk factors and development of chronic lower limb vein disease.
详细描述
Multicenter prospective cohort observational study based on a termless epidemiological registry.
Periodic inspection and collection of data from the subjects is carried out annually, in the last quarter of the current year.
Patient data is recorded in a promising digital database and is constantly updated.
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
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A family members of the researcher (spouse, childrens, brothers and sisters, parents) or the researcher himself
- •The possibility of annual clinical and ultrasound assessment of the venous system of the observed individuals
排除标准
- •Any invasive treatment of the chronic venous disorder in anamnesis
- •Venous thrombosis in the anamnesis or at the time of inclusion
研究组 & 干预措施
Patients with Chronic Veinous Disease
Individuals who have signs of chronic venous diseases of lower legs according to CEAP classification (telangiectases, varicose veins, venous edema, skin hyperpigmentation, lipodermatosclerosis, venous ulcer).
Patients without Chronic Venous Disease
Individuals who do not have signs of chronic venous diseases of lower legs according to Clinical, Etiologic, Anatomic and Pathophysiologic classification (CEAP)
结局指标
主要结局
Incidence of chronic venous insufficiency
时间窗: 1 year
Number of Participants with the first identified sign of chronic venous insufficiency (venous edema, venous eczema, hyperpigmentation of the skin, lipodermatosclerosis, venous ulcer)
Incidence of superficial vein thrombosis
时间窗: 1 year
Number of Participants with the first identified sign of superficial vein thrombosis
Incidence of Chronic Venous Disease
时间窗: 1 year
Number of Participants with the first identified signs of chronic venous disease according to CEAP classification (telangiectasia, varicose veins, edema)
Natural Course of Chronic Venous Disease
时间窗: 1 year
Progression of CVD will be measured as a change in clinical class of CVD according to CEAP classification in every individual affected by CVD
次要结局
未报告次要终点
研究者
Evgeny Ilyukhin
Principal Investigator
Russian Phlebological Association