RRCVD: Registry for Chronic Venous Disease Incidence and Natural Course

Sponsor

Russian Phlebological Association (Other)

Overall Status

Recruiting

CT.gov ID

NCT04487314

Collaborator

(none)

10,000

Enrollment

Location

360.4

Anticipated Duration (Months)

27.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Anticipated Enrollment :

10000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Russian Registry for Chronic Venous Disease Incidence and Natural Course

Actual Study Start Date :

Aug 20, 2020

Anticipated Primary Completion Date :

Sep 1, 2050

Anticipated Study Completion Date :

Sep 1, 2050

Arms and Interventions

Arm	Intervention/Treatment
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).

Outcome Measures

Primary Outcome Measures

Incidence of Chronic Venous Disease [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 [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
Incidence of chronic venous insufficiency [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 [1 year]
Number of Participants with the first identified sign of superficial vein thrombosis

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	"Medalp" private surgery clinic	Saint Petersburg		Russian Federation	197350

Sponsors and Collaborators

Russian Phlebological Association

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Evgeny Ilyukhin, Principal Investigator, Russian Phlebological Association

ClinicalTrials.gov Identifier:

NCT04487314

Other Study ID Numbers:

RPA 10.001

First Posted:

Jul 27, 2020

Last Update Posted:

Apr 27, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Varicose Veins

Study Results

No Results Posted as of Apr 27, 2022