Registry for Chronic Venous Disease Incidence and Natural Course (RRCVD)

Russian Registry for Chronic Venous Disease Incidence and Natural Course

A prospective cohort study of patients with primary varicose veins to assess the morbidity, risk factors and development of chronic lower limb vein disease.

Study Overview

• Status: Recruiting
• Conditions: Varicose Veins of Lower Limb

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.

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Evgeny Ilyukhin, MD, PhD; Phone Number: +79218451722; Email: evgeny@ilyukhin.info

Study Locations

• Russian Federation
  • Saint Petersburg, Russian Federation, 197350
    • Recruiting
    • "Medalp" private surgery clinic
    • Contact: Evgeny Ilyukhin, PhD; Email: euugen.iluhin@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The main cohort is formed from those who do not have CVD, 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 CVD 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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)
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Chronic Venous Disease	Number of Participants with the first identified signs of chronic venous disease according to CEAP classification (telangiectasia, varicose veins, edema)	1 year
Natural Course of Chronic Venous Disease	Progression of CVD will be measured as a change in clinical class of CVD according to CEAP classification in every individual affected by CVD	1 year
Incidence of chronic venous insufficiency	Number of Participants with the first identified sign of chronic venous insufficiency (venous edema, venous eczema, hyperpigmentation of the skin, lipodermatosclerosis, venous ulcer)	1 year
Incidence of superficial vein thrombosis	Number of Participants with the first identified sign of superficial vein thrombosis	1 year

Collaborators and Investigators

• Sponsor: Russian Phlebological Association

Publications and helpful links

Helpful Links

• This is a website specially created for this register.
• The Association of Phlebologists of Russia already has 2 registers, which registered in ClinicalTrials.gov and on the basis of which clinical trials are conducted.

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2020
• Primary Completion (Estimated): September 1, 2050
• Study Completion (Estimated): September 1, 2050

Study Registration Dates

• First Submitted: July 9, 2020
• First Submitted That Met QC Criteria: July 22, 2020
• First Posted (Actual): July 27, 2020

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Varicose Veins
• Other Study ID Numbers: RPA 10.001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No