Clinical trial NCT04901845: VEIN Health - CVD Prevalence and Characteristics
Official title: VEIN Health Chronic Venous Disease at Primary and Specialized Healthcare Level -Update on Prevalence and Characteristics
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Venous Disease
Keywords: Chronic Venous Disease
Prevalence
Characteristics
Management tactics evaluation
Risk-factors
Distribution of CEAP stages
Lead sponsor: Bokhua Memorial Cardiovascular Center
Sponsor class: OTHER
Collaborators: name: Chapidze Emergency Cardiology Center
First posted: 2021-05-26
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients applying to consultation due to any reason

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* Age above 18 years
* Patient consented to participate

Exclusion Criteria:

* Patient applying due to emergency situation

Primary outcomes:
measure: Prevalence of CVD
timeFrame: 2 weeks
measure: Distribution of CEAP stages
timeFrame: 2 weeks
measure: Prevalence of risk-factors associated with CVD
timeFrame: 2 weeks
measure: Management tactics
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bokhua Memorial Cardiovascular Center
name: Nugzar Pargalava, MD, PhD
role: STUDY_DIRECTOR
affiliation: Chapidze Emergency Cardiology Center
name: Zaza Lazarahvili, MD, PhD
role: STUDY_DIRECTOR
affiliation: Bokhua Memorial Cardiovascular Center
name: Mamuka Bokuchava, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.