Chronic Venous InsufficiencyNCT03900234
Prevalence of Chronic Venous Disease in General Population
An observational study of Chronic Venous Insufficiency, run by Pirogov Russian National Research Medical University at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Venous Insufficiency
- How many people
- 783 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jul 2015to 31 Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All the residents of 10 years and more living in the same settlement, willing to participate will be included
Who may be able to join
- 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
Who cannot join
- age 9 years and less
- not signed informed consent
Trial locations and contacts
1 site in 1 country.
Russia1 site
Pirogov Russian National Research Medical University
Moscow, 117997
About this study
Official title: Cross-Sectional Population Based Study on Prevalence and Risk Factors for Chronic Venous Disease in General Population
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.
Read the detailed description
The study has cross-sectional design. All the residents aged 10 and more, living in the single rural settlement located in Central Russia will be invited to participate in the study.
Those who agree, will be examined both clinically and by duplex ultrasound. Medical history of participants will be taken, demographic data will be collected. Possible factors that may influence CVD development will be registered.
Signs and symptoms of CVD will be registered. Duplex ultrasound will be used in every resident to reveal pathological venous reflux in deep and superficial veins.
- Conditions
- Chronic Venous Insufficiency
- Being tested
- No intervention will be administered
- Keywords
- chronic venous disease, prevalence, risk factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention will be administeredOther
No intervention will be studied. Clinical and ultrasound examinations will be used to find the prevalence of CVD.
| Study group | Role | What they receive |
|---|---|---|
| Residents of the single rural settlement | No interventions will be administered Receives: Other: No intervention will be administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to Sept. 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start1 Jul 2015
- Primary completion31 Aug 2015
- Study completion31 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Venous InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 783 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pirogov Russian National Research Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Igor Zolotukhin, Pirogov Russian National Research Medical University
- Investigators
- Igor Zolotukhin, Prof, Principal investigator, Russian National Research Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900234
- Sponsor's protocol ID
- 15
- Status last verified
- Apr 2019
- First submitted
- 29 Mar 2019
- Last updated
- 2 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD are going to be shared with other researchers
Publications
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.
PubMed 30958033
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-Sectional Population Based Study on Prevalence and Risk Factors for Chronic Venous Disease in General Population
- ClinicalTrials.gov ID
- NCT03900234
- Acronym / sponsor ID
- 15
- Conditions
- Chronic Venous Insufficiency
- Keywords
- chronic venous disease, prevalence, risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 783 participants (actual)
- Lead sponsor
- Pirogov Russian National Research Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 31 Aug 2015 (actual)
- Study completion
- 31 Aug 2015 (actual)
- First posted
- 2 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study has cross-sectional design. All the residents aged 10 and more, living in the single rural settlement located in Central Russia will be invited to participate in the study.
Those who agree, will be examined both clinically and by duplex ultrasound. Medical history of participants will be taken, demographic data will be collected. Possible factors that may influence CVD development will be registered.
Signs and symptoms of CVD will be registered. Duplex ultrasound will be used in every resident to reveal pathological venous reflux in deep and superficial veins.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Residents of the single rural settlement | – | Other: No intervention will be administeredNo interventions will be administered |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All the residents of 10 years and more living in the same settlement, willing to participate will be included
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- age 9 years and less
- not signed informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention will be administeredNo intervention will be studied. Clinical and ultrasound examinations will be used to find the prevalence of CVD. | Other | Residents of the single rural settlement |
Primary outcome
Presence of chronic venous disease
Time frame: up to Sept. 2015
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
- Derived from this study: PubMed 30958033Zolotukhin 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.
- Individual participant dataSharing planned: No. No IPD are going to be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Igor Zolotukhin, Prof principal investigator
Russian National Research Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Venous Insufficiency, run by Pirogov Russian National Research Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of chronic venous disease (time frame: up to Sept. 2015). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03900234, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2019.