Prospective Cohort Study for Varicose Veins Incidence and Natural Course (VINCI)

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.

Study Overview

• Status: Recruiting
• Conditions: Venous Insufficiency; Varicose Veins of Lower Limb; Thromboses, Venous

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 digital database and is constantly updated

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Igor Zolotukhin, MD, PhD; Phone Number: +79255182479; Email: zoloto70@bk.ru

Study Locations

• Russian Federation
  • Saint Petersburg, Russian Federation, 197350
    • Recruiting
    • "Medalp" private surgery clinic
    • Contact: Evgeny Ilyukhin, PhD; Email: eugen.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 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.

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 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of primary varicose veins	Number of Participants with the first identified varicose veins (class C2 according to CEAP classification)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression of primary varicose veins	The presence of varicose veins in new areas of the lower extremites (each limb is divided into 8 areas: thigh - anterior, posterior, medial, lateral area; lower leg - anterior, posterior, medial, lateral area)	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 first episode of superficial vein thrombosis	1 year
Incidence of reticular and telangiectatic leg veins	Number of Participants with the first identified eticular and telangiectatic leg veins ((class C1 according to CEAP classification)	1 year
Progression of reticular and telangiectatic leg veins	The presence of reticular and telangiectatic leg veins in new areas of the lower extremites (each limb is divided into 8 areas: thigh - anterior, posterior, medial, lateral area; lower leg - anterior, posterior, medial, lateral area)	1 year

Collaborators and Investigators

• Sponsor: Russian Phlebological Association

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030

Study Registration Dates

• First Submitted: September 5, 2020
• First Submitted That Met QC Criteria: September 5, 2020
• First Posted (Actual): September 14, 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; Embolism and Thrombosis; Thrombosis; Venous Thrombosis; Venous Insufficiency; Varicose Veins
• Other Study ID Numbers: RPA 7.001.

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