Prospective Cohort Study for Varicose Veins Incidence and Natural Course

NCT04546750 | Recruiting

• 1 other identifier: RPA 7.001.
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Varicose Veins of Lower Limb; Thromboses, Venous; Venous Insufficiency

Outcome Measures

Primary Outcomes (1)

• Incidence of primary varicose veins

  Number of Participants with the first identified varicose veins (class C2 according to CEAP classification)

  1 year

Secondary Outcomes (5)

• Progression of primary varicose veins

  1 year

• Incidence of chronic venous insufficiency

  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

Study Arms (2)

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)

Patients with Varicose Veins

Individuals who have varicose veins of lower legs: C2 Ep class according to Clinical, Etiologic, Anatomic and Pathophysiologic classification (CEAP)

Eligibility Criteria

• Age: 10 Years+
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The main cohort is formed from those who do not have varicose veins, who are affected by different factors that we register (various physical activities, the presence or absence of pregnancy, etc.). An additional cohort is formed from those who have varicose veins at the time of inclusion. The goal is to track the natural evolution (progression) of the disease, to evaluate the incidence and risk factors of complications. An extremely important criterion for the formation of the study population is the possibility to control the lower legs veins of observed individuals by a qualified vascular specialist. To date, a qualitative assessment of veins according to the CEAP classification is a weak point in longitudinal epidemiological studies.

You may qualify if:

• 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

You may not qualify if:

• Any invasive treatment of the chronic venous disorder in anamnesis

Sponsors & Collaborators

• Russian Phlebological Association: lead

Study Sites (1)

"Medalp" private surgery clinic

Saint Petersburg, 197350, Russia

RECRUITING

Related Links

• The accumulation of data will be carried out on the basis of an termless Russian epidemiological registry, ClinicalTrials.gov Identifier: NCT04487314

MeSH Terms

Conditions

Venous Thrombosis; Venous Insufficiency

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Igor Zolotukhin, MD, PhD

CONTACT

+79255182479; zoloto70@bk.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2020
• First Posted: September 14, 2020
• Study Start: September 1, 2020
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)