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Trial record 1 of 1 for:    NCT04487314
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Registry for Chronic Venous Disease Incidence and Natural Course (RRCVD)

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ClinicalTrials.gov Identifier: NCT04487314
Recruitment Status : Recruiting
First Posted : July 27, 2020
Last Update Posted : April 27, 2022
Sponsor:
Information provided by (Responsible Party):
Evgeny Ilyukhin, Russian Phlebological Association

Study Description
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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
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
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Study Type : Observational
Estimated 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 : August 20, 2020
Estimated Primary Completion Date : September 1, 2050
Estimated Study Completion Date : September 1, 2050

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins

Groups and Cohorts
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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).


Outcome Measures
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Primary Outcome Measures :
  1. 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)

  2. 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

  3. 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)

  4. Incidence of superficial vein thrombosis [ Time Frame: 1 year ]
    Number of Participants with the first identified sign of superficial vein thrombosis


Eligibility Criteria
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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04487314


Contacts
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Contact: Evgeny Ilyukhin, MD, PhD +79218451722 evgeny@ilyukhin.info

Locations
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Russian Federation
"Medalp" private surgery clinic Recruiting
Saint Petersburg, Russian Federation, 197350
Contact: Evgeny Ilyukhin, PhD       euugen.iluhin@gmail.com   
Sponsors and Collaborators
Russian Phlebological Association
More Information
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Additional Information:

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Responsible Party: Evgeny Ilyukhin, Principal Investigator, Russian Phlebological Association
ClinicalTrials.gov Identifier: NCT04487314    
Other Study ID Numbers: RPA 10.001
First Posted: July 27, 2020    Key Record Dates
Last Update Posted: April 27, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Varicose Veins
Vascular Diseases
Cardiovascular Diseases