Chronic Venous DiseaseNCT04901845
VEIN Health - CVD Prevalence and Characteristics
An observational study of Chronic Venous Disease, run by Bokhua Memorial Cardiovascular Center.
Trial summary
Epidemiology Study to learn prevalence and characteristics of CVD at Primary and Specialized healthcare level Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Venous Disease
- How many people
- 10,000 participants
- Where
- No sites listed yet
- Study dates
- May 2021to Sep 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients applying to consultation due to any reason
Who may be able to join
- Age above 18 years
- Patient consented to participate
Who cannot join
- Patient applying due to emergency situation
Trial locations and contacts
No sites are listed yet.
About this study
Official title: VEIN Health Chronic Venous Disease at Primary and Specialized Healthcare Level -Update on Prevalence and Characteristics
Epidemiology Study to learn prevalence and characteristics of CVD at Primary and Specialized healthcare level
Read the detailed description
Cross sectional study that will evaluate prevalence, characteristics, diagnostic and treatment status of the patients with Chronic Venous Disease at primary or specialized healthcare level during 2 week period. No interventions are made. Information on patient demographic, physical, clinical parameters, medical history data and procedures performed during visit in routine daily practice of physicians is registered and analyzed.
- Conditions
- Chronic Venous Disease
- Being tested
- No intervention provided
- Keywords
- Chronic Venous Disease, Prevalence, Characteristics, Management tactics evaluation, Risk-factors, Distribution of CEAP stages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention providedOther
Study is provided in the usual daily practice of the physicians without interventions made in their practice
| Study group | Role | What they receive |
|---|---|---|
| Patients applying to Primary Healthcare Consultation | Consequent patients applying to the Primary healthcare to consult for any reason during 2 week period Receives: Other: No intervention provided | |
| Patients applying to Specialized Healthcare Consultation | Consequent patients applying to the Specialized healthcare to consult for any reason during 2 week period Receives: Other: No intervention provided |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of CVD
Percent of CVD symptomatic patients among patients applying to consultation for any reason
Measured: 2 weeks
Distribution of CEAP stages
Percent of CVD patients with various CEAP stages
Measured: 2 weeks
Prevalence of risk-factors associated with CVD
Frequency of risk-factors associated with CVD
Measured: 2 weeks
Management tactics
Tactics chosen by physicians to manage CVD
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study startMay 2021 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Venous DiseaseStudies 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
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bokhua Memorial Cardiovascular Center
- Sponsor type
- University, hospital or other
- Collaborators
- Chapidze Emergency Cardiology Center
- Responsible party
- Principal investigator, Mamuka Bokuchava, Bokhua Memorial Cardiovascular Center
- Investigators
- Nugzar Pargalava, MD, PhD, Study director, Bokhua Memorial Cardiovascular CenterZaza Lazarahvili, MD, PhD, Study director, Chapidze Emergency Cardiology CenterMamuka Bokuchava, MD, PhD, Study director, Bokhua Memorial Cardiovascular Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04901845
- Sponsor's protocol ID
- IC4-05682-009-GEO
- Status last verified
- May 2021
- First submitted
- 5 May 2021
- Last updated
- 26 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shabani Varaki E, Gargiulo GD, Penkala S, Breen PP. Peripheral vascular disease assessment in the lower limb: a review of current and emerging non-invasive diagnostic methods. Biomed Eng Online. 2018 May 11;17(1):61. doi: 10.1186/s12938-018-0494-4.
PubMed 29751811Nicolaides A, Kakkos S, Baekgaard N, Comerota A, de Maeseneer M, Eklof B, Giannoukas AD, Lugli M, Maleti O, Myers K, Nelzen O, Partsch H, Perrin M. Management of chronic venous disorders of the lower limbs. Guidelines According to Scientific Evidence. Part I. Int Angiol. 2018 Jun;37(3):181-254. doi: 10.23736/S0392-9590.18.03999-8. No abstract available.
PubMed 29871479Gloviczki P, Comerota AJ, Dalsing MC, Eklof BG, Gillespie DL, Gloviczki ML, Lohr JM, McLafferty RB, Meissner MH, Murad MH, Padberg FT, Pappas PJ, Passman MA, Raffetto JD, Vasquez MA, Wakefield TW; Society for Vascular Surgery; American Venous Forum. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2011 May;53(5 Suppl):2S-48S. doi: 10.1016/j.jvs.2011.01.079.
PubMed 21536172Rabe E, Guex JJ, Puskas A, Scuderi A, Fernandez Quesada F; VCP Coordinators. Epidemiology of chronic venous disorders in geographically diverse populations: results from the Vein Consult Program. Int Angiol. 2012 Apr;31(2):105-15.
PubMed 22466974
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VEIN Health Chronic Venous Disease at Primary and Specialized Healthcare Level -Update on Prevalence and Characteristics
- ClinicalTrials.gov ID
- NCT04901845
- Acronym / sponsor ID
- IC4-05682-009-GEO
- Conditions
- Chronic Venous Disease
- Keywords
- Chronic Venous Disease, Prevalence, Characteristics, Management tactics evaluation, Risk-factors, Distribution of CEAP stages
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Bokhua Memorial Cardiovascular CenterUniversity, hospital or other
- Collaborators
- Chapidze Emergency Cardiology Center
- Study start
- May 2021 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 26 May 2021 (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.
Epidemiology Study to learn prevalence and characteristics of CVD at Primary and Specialized healthcare level
Detailed description
Cross sectional study that will evaluate prevalence, characteristics, diagnostic and treatment status of the patients with Chronic Venous Disease at primary or specialized healthcare level during 2 week period. No interventions are made. Information on patient demographic, physical, clinical parameters, medical history data and procedures performed during visit in routine daily practice of physicians is registered and analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients applying to Primary Healthcare Consultation | – | Other: No intervention providedConsequent patients applying to the Primary healthcare to consult for any reason during 2 week period |
| Patients applying to Specialized Healthcare Consultation | – | Other: No intervention providedConsequent patients applying to the Specialized healthcare to consult for any reason during 2 week period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients applying to consultation due to any reason
Key inclusion criteria (2 listed)
- Age above 18 years
- Patient consented to participate
Key exclusion criteria (1 listed)
- Patient applying due to emergency situation
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 providedStudy is provided in the usual daily practice of the physicians without interventions made in their practice | Other | Patients applying to Primary Healthcare Consultation, Patients applying to Specialized Healthcare Consultation |
Primary outcome
Prevalence of CVD
Time frame: 2 weeks
Percent of CVD symptomatic patients among patients applying to consultation for any reason
Distribution of CEAP stages
Time frame: 2 weeks
Percent of CVD patients with various CEAP stages
Prevalence of risk-factors associated with CVD
Time frame: 2 weeks
Frequency of risk-factors associated with CVD
Management tactics
Time frame: 2 weeks
Tactics chosen by physicians to manage CVD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
- Background: PubMed 29751811Shabani Varaki E, Gargiulo GD, Penkala S, Breen PP. Peripheral vascular disease assessment in the lower limb: a review of current and emerging non-invasive diagnostic methods. Biomed Eng Online. 2018 May 11;17(1):61. doi: 10.1186/s12938-018-0494-4.
- Background: PubMed 29871479Nicolaides A, Kakkos S, Baekgaard N, Comerota A, de Maeseneer M, Eklof B, Giannoukas AD, Lugli M, Maleti O, Myers K, Nelzen O, Partsch H, Perrin M. Management of chronic venous disorders of the lower limbs. Guidelines According to Scientific Evidence. Part I. Int Angiol. 2018 Jun;37(3):181-254. doi: 10.23736/S0392-9590.18.03999-8. No abstract available.
- Background: PubMed 21536172Gloviczki P, Comerota AJ, Dalsing MC, Eklof BG, Gillespie DL, Gloviczki ML, Lohr JM, McLafferty RB, Meissner MH, Murad MH, Padberg FT, Pappas PJ, Passman MA, Raffetto JD, Vasquez MA, Wakefield TW; Society for Vascular Surgery; American Venous Forum. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2011 May;53(5 Suppl):2S-48S. doi: 10.1016/j.jvs.2011.01.079.
- Background: PubMed 22466974Rabe E, Guex JJ, Puskas A, Scuderi A, Fernandez Quesada F; VCP Coordinators. Epidemiology of chronic venous disorders in geographically diverse populations: results from the Vein Consult Program. Int Angiol. 2012 Apr;31(2):105-15.
- Individual participant dataSharing planned: Undecided
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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.
Nugzar Pargalava, MD, PhD study director
Bokhua Memorial Cardiovascular Center
Zaza Lazarahvili, MD, PhD study director
Chapidze Emergency Cardiology Center
Mamuka Bokuchava, MD, PhD study director
Bokhua Memorial Cardiovascular Center
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Venous Disease, run by Bokhua Memorial Cardiovascular Center.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mamuka Bokuchava, MD, PhD (+995577434075, bmamuka@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of CVD (time frame: 2 weeks). The study lists 4 primary outcomes in all. 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 NCT04901845, which also lists 4 linked publications.
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 26 May 2021.