Prospective Cohort Study for Varicose Veins Incidence and Natural Course
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Incidence of primary varicose veins
研究概览
简要总结
A prospective study of individuals without varicose veins and who have primary varicose veins to assess the morbidity, risk factors and natural course 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 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 Varicose Veins
Individuals who have varicose veins of lower legs: C2 Ep class according to Clinical, Etiologic, Anatomic and Pathophysiologic classification (CEAP)
Patients without Varicose Veins
Individuals who do not have varicose veins of lower legs: C0, C1 classes according to Clinical, Etiologic, Anatomic and Pathophysiologic classification (CEAP)
结局指标
主要结局
Incidence of primary varicose veins
时间窗: 1 year
Number of Participants with the first identified varicose veins (class C2 according to CEAP classification)
次要结局
- Incidence of chronic venous insufficiency(1 year)
- Progression of primary varicose veins(1 year)
- Incidence of superficial vein thrombosis(1 year)
- Incidence of reticular and telangiectatic leg veins(1 year)
- Progression of reticular and telangiectatic leg veins(1 year)