NCT03900234

Brief Summary

This study is designed to find prevalence and risk factors for chronic venous disease (CVD) in the general population. All the resident, who live in a single rural settlement will be invited to participate.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
783

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2015

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 2, 2019

Completed
Last Updated

April 2, 2019

Status Verified

April 1, 2019

Enrollment Period

2 months

First QC Date

March 29, 2019

Last Update Submit

April 1, 2019

Conditions

Keywords

chronic venous diseaseprevalencerisk factors

Outcome Measures

Primary Outcomes (1)

  • Presence of chronic venous disease

    As a disease positive subjects with any morphological and functional abnormalities of the venous system of long duration manifested either by symptoms and/or signs indicating the need for investigation and/or care will be considered

    up to Sept. 2015

Study Arms (1)

Residents of the single rural settlement

No interventions will be administered

Other: No intervention will be administered

Interventions

No intervention will be studied. Clinical and ultrasound examinations will be used to find the prevalence of CVD.

Residents of the single rural settlement

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All the residents of 10 years and more living in the same settlement, willing to participate will be included

You may qualify if:

  • residents living in the rural settlement where study will be conducted
  • both female and male
  • age 10 years and more
  • agree to participate
  • signed infromed consent

You may not qualify if:

  • age 9 years and less
  • not signed informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pirogov Russian National Research Medical University

Moscow, 117997, Russia

Location

Related Publications (1)

  • Zolotukhin IA, Seliverstov EI, Shevtsov YN, Avakiants IP, Tatarintsev AM, Kirienko AI. Risk factors for venous symptoms in Russian patients with chronic venous disease. Curr Med Res Opin. 2019 Sep;35(9):1583-1587. doi: 10.1080/03007995.2019.1605050. Epub 2019 May 13.

Study Officials

  • Igor Zolotukhin, Prof

    Russian National Research Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 29, 2019

First Posted

April 2, 2019

Study Start

July 1, 2015

Primary Completion

August 31, 2015

Study Completion

August 31, 2015

Last Updated

April 2, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

No IPD are going to be shared with other researchers

Locations