NCT04901845

Brief Summary

Epidemiology Study to learn prevalence and characteristics of CVD at Primary and Specialized healthcare level

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Status
unknown

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

May 1, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 26, 2021

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

May 26, 2021

Status Verified

May 1, 2021

Enrollment Period

1 month

First QC Date

May 5, 2021

Last Update Submit

May 23, 2021

Conditions

Chronic Venous Disease

Keywords

Chronic Venous DiseasePrevalenceCharacteristicsManagement tactics evaluationRisk-factorsDistribution of CEAP stages

Outcome Measures

Primary Outcomes (4)

  • Prevalence of CVD

    Percent of CVD symptomatic patients among patients applying to consultation for any reason

    2 weeks

  • Distribution of CEAP stages

    Percent of CVD patients with various CEAP stages

    2 weeks

  • Prevalence of risk-factors associated with CVD

    Frequency of risk-factors associated with CVD

    2 weeks

  • Management tactics

    Tactics chosen by physicians to manage CVD

    2 weeks

Study Arms (2)

Patients applying to Primary Healthcare Consultation

Consequent patients applying to the Primary healthcare to consult for any reason during 2 week period

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

Other: No intervention provided

Interventions

No intervention providedOTHER

Study is provided in the usual daily practice of the physicians without interventions made in their practice

Patients applying to Primary Healthcare ConsultationPatients applying to Specialized Healthcare Consultation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients applying to consultation due to any reason

You may qualify if:

  • Age above 18 years
  • Patient consented to participate

You may not qualify if:

  • Patient applying due to emergency situation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 29751811BACKGROUND

  • Nicolaides 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.

    PMID: 29871479BACKGROUND

  • Gloviczki 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.

    PMID: 21536172BACKGROUND

  • Rabe 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.

    PMID: 22466974BACKGROUND

Study Officials

  • Nugzar Pargalava, MD, PhD

    Bokhua Memorial Cardiovascular Center

    STUDY DIRECTOR

  • Zaza Lazarahvili, MD, PhD

    Chapidze Emergency Cardiology Center

    STUDY DIRECTOR

  • Mamuka Bokuchava, MD, PhD

    Bokhua Memorial Cardiovascular Center

    STUDY DIRECTOR

Central Study Contacts

Mamuka Bokuchava, MD, PhD

CONTACT

+995577434075bmamuka@hotmail.com

Manana Silagava, MD

CONTACT

+995599091728mano.silagava@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
TSSU Professor; Deputy Director of Bokhua Memorial Cardiovascular Center

Study Record Dates

First Submitted

May 5, 2021

First Posted

May 26, 2021

Study Start

May 1, 2021

Primary Completion

June 1, 2021

Study Completion

September 1, 2021

Last Updated

May 26, 2021

Record last verified: 2021-05