VEIN Health - CVD Prevalence and Characteristics

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

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Venous Disease
• Intervention / Treatment: Other: No intervention provided

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 Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

• Study Contact: Name: Mamuka Bokuchava, MD, PhD; Phone Number: +995577434075; Email: bmamuka@hotmail.com
• Study Contact Backup: Name: Manana Silagava, MD; Phone Number: +995599091728; Email: mano.silagava@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients applying to consultation due to any reason

Description

Inclusion Criteria:

• Age above 18 years
• Patient consented to participate

Exclusion Criteria:

• Patient applying due to emergency situation

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Study is provided in the usual daily practice of the physicians without interventions made in their practice
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; Study is provided in the usual daily practice of the physicians without interventions made in their practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Bokhua Memorial Cardiovascular Center
• Collaborators: Chapidze Emergency Cardiology Center
• Investigators: Study Director: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2021
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: May 5, 2021
• First Submitted That Met QC Criteria: May 23, 2021
• First Posted (Actual): May 26, 2021

Study Record Updates

• Last Update Posted (Actual): May 26, 2021
• Last Update Submitted That Met QC Criteria: May 23, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Prevalence; Chronic Venous Disease; Characteristics; Management tactics evaluation; Risk-factors; Distribution of CEAP stages
• Other Study ID Numbers: IC4-05682-009-GEO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No