<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04487314</url>
  </required_header>
  <id_info>
    <org_study_id>RPA 10.001</org_study_id>
    <nct_id>NCT04487314</nct_id>
  </id_info>
  <brief_title>Registry for Chronic Venous Disease Incidence and Natural Course</brief_title>
  <acronym>RRCVD</acronym>
  <official_title>Russian Registry for Chronic Venous Disease Incidence and Natural Course</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Russian Phlebological Association</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Russian Phlebological Association</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A prospective cohort study of patients with primary varicose veins to assess the morbidity,&#xD;
      risk factors and development of chronic lower limb vein disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Multicenter prospective cohort observational study based on a termless epidemiological&#xD;
      registry.&#xD;
&#xD;
      Periodic inspection and collection of data from the subjects is carried out annually, in the&#xD;
      last quarter of the current year.&#xD;
&#xD;
      Patient data is recorded in a promising digital database and is constantly updated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 20, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2050</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2050</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Chronic Venous Disease</measure>
    <time_frame>1 year</time_frame>
    <description>Number of Participants with the first identified signs of chronic venous disease according to CEAP classification (telangiectasia, varicose veins, edema)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Natural Course of Chronic Venous Disease</measure>
    <time_frame>1 year</time_frame>
    <description>Progression of CVD will be measured as a change in clinical class of CVD according to CEAP classification in every individual affected by CVD</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of chronic venous insufficiency</measure>
    <time_frame>1 year</time_frame>
    <description>Number of Participants with the first identified sign of chronic venous insufficiency (venous edema, venous eczema, hyperpigmentation of the skin, lipodermatosclerosis, venous ulcer)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of superficial vein thrombosis</measure>
    <time_frame>1 year</time_frame>
    <description>Number of Participants with the first identified sign of superficial vein thrombosis</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Varicose Veins of Lower Limb</condition>
  <arm_group>
    <arm_group_label>Patients without Chronic Venous Disease</arm_group_label>
    <description>Individuals who do not have signs of chronic venous diseases of lower legs according to Clinical, Etiologic, Anatomic and Pathophysiologic classification (CEAP)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with Chronic Veinous Disease</arm_group_label>
    <description>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).</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The main cohort is formed from those who do not have CVD, who are affected by different&#xD;
        factors that we register (various physical activities, the presence or absence of&#xD;
        pregnancy, etc.).&#xD;
&#xD;
        An additional cohort is formed from those who have CVD at the time of inclusion.&#xD;
&#xD;
        The goal is to track the natural evolution (progression) of the disease, to evaluate the&#xD;
        incidence and risk factors of complications.&#xD;
&#xD;
        An extremely important criterion for the formation of the study population is the&#xD;
        possibility to control the lower legs veins of observed individuals by a qualified vascular&#xD;
        specialist. To date, a qualitative assessment of veins according to the CEAP classification&#xD;
        is a weak point in longitudinal epidemiological studies.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A family members of the researcher (spouse, childrens, brothers and sisters, parents)&#xD;
             or the researcher himself&#xD;
&#xD;
          -  The possibility of annual clinical and ultrasound assessment of the venous system of&#xD;
             the observed individuals&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any invasive treatment of the chronic venous disorder in anamnesis&#xD;
&#xD;
          -  Venous thrombosis in the anamnesis or at the time of inclusion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Evgeny Ilyukhin, MD, PhD</last_name>
    <phone>+79218451722</phone>
    <email>evgeny@ilyukhin.info</email>
  </overall_contact>
  <location>
    <facility>
      <name>&quot;Medalp&quot; private surgery clinic</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197350</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Evgeny Ilyukhin, PhD</last_name>
      <email>euugen.iluhin@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <link>
    <url>https://epid.venousregistry.org/</url>
    <description>This is a website specially created for this register.</description>
  </link>
  <link>
    <url>https://www.venousregistry.org/</url>
    <description>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.</description>
  </link>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>April 26, 2022</last_update_submitted>
  <last_update_submitted_qc>April 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Russian Phlebological Association</investigator_affiliation>
    <investigator_full_name>Evgeny Ilyukhin</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Varicose Veins</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04487314
org study id: RPA 10.001
nct id: NCT04487314
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A prospective cohort study of patients with primary varicose veins to assess the morbidity,
      risk factors and development of chronic lower limb vein disease.
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.
observational model: Cohort
time perspective: Prospective
measure: Incidence of Chronic Venous Disease
time frame: 1 year
description: Number of Participants with the first identified signs of chronic venous disease according to CEAP classification (telangiectasia, varicose veins, edema)
measure: Natural Course of Chronic Venous Disease
time frame: 1 year
description: Progression of CVD will be measured as a change in clinical class of CVD according to CEAP classification in every individual affected by CVD
measure: Incidence of chronic venous insufficiency
time frame: 1 year
description: Number of Participants with the first identified sign of chronic venous insufficiency (venous edema, venous eczema, hyperpigmentation of the skin, lipodermatosclerosis, venous ulcer)
measure: Incidence of superficial vein thrombosis
time frame: 1 year
description: Number of Participants with the first identified sign of superficial vein thrombosis
arm group label: Patients without Chronic Venous Disease
description: Individuals who do not have signs of chronic venous diseases of lower legs according to Clinical, Etiologic, Anatomic and Pathophysiologic classification (CEAP)
arm group label: Patients with Chronic Veinous Disease
description: 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).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 10 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Evgeny Ilyukhin, MD, PhD
phone: +79218451722
email: evgeny@ilyukhin.info
facility: 
status: Recruiting
contact: 
country: Russian Federation
url: https://epid.venousregistry.org/
description: This is a website specially created for this register.
url: https://www.venousregistry.org/
description: 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.
responsible party type: Principal Investigator
investigator affiliation: Russian Phlebological Association
investigator full name: Evgeny Ilyukhin
investigator title: Principal Investigator
mesh term: Varicose Veins
sharing ipd: No