Russian Registry for Chronic Venous Disease Incidence and Natural Course
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Varicose Veins of Lower Limb
- Sponsor
- Russian Phlebological Association
- Enrollment
- 10000
- Locations
- 1
- Primary Endpoint
- Incidence of chronic venous insufficiency
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
A prospective cohort study of patients with primary varicose veins to assess the morbidity, risk factors and development of chronic lower limb vein disease.
Detailed Description
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.
Investigators
Evgeny Ilyukhin
Principal Investigator
Russian Phlebological Association
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Any invasive treatment of the chronic venous disorder in anamnesis
- •Venous thrombosis in the anamnesis or at the time of inclusion
Outcomes
Primary Outcomes
Incidence of chronic venous insufficiency
Time Frame: 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
Time Frame: 1 year
Number of Participants with the first identified sign of superficial vein thrombosis
Incidence of Chronic Venous Disease
Time Frame: 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
Time Frame: 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