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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04546750
Recruitment Status : Recruiting
First Posted : September 14, 2020
Last Update Posted : October 6, 2020
Sponsor:
Information provided by (Responsible Party):
Russian Phlebological Association

Study Description
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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.

Condition or disease
Varicose Veins of Lower Limb Thromboses, Venous Venous Insufficiency

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 Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Cohort Study for Varicose Veins Incidence and Natural Course
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 2030
Estimated Study Completion Date : September 2030

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 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)


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of primary varicose veins [ Time Frame: 1 year ]
    Number of Participants with the first identified varicose veins (class C2 according to CEAP classification)


Secondary Outcome Measures :
  1. Progression of primary varicose veins [ Time Frame: 1 year ]
    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)

  2. 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)

  3. Incidence of superficial vein thrombosis [ Time Frame: 1 year ]
    Number of participants with first episode of superficial vein thrombosis

  4. Incidence of reticular and telangiectatic leg veins [ Time Frame: 1 year ]
    Number of Participants with the first identified eticular and telangiectatic leg veins ((class C1 according to CEAP classification)

  5. Progression of reticular and telangiectatic leg veins [ Time Frame: 1 year ]
    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)


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

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): NCT04546750


Contacts
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Contact: Igor Zolotukhin, MD, PhD +79255182479 zoloto70@bk.ru

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

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Responsible Party: Russian Phlebological Association
ClinicalTrials.gov Identifier: NCT04546750    
Other Study ID Numbers: RPA 7.001.
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: October 2020
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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Thrombosis
Venous Insufficiency
Varicose Veins
Venous Thrombosis
 Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases