VEIN Health - CVD Prevalence and Characteristics

Chronic Venous Disease Clinical Trial

Official title:

VEIN Health Chronic Venous Disease at Primary and Specialized Healthcare Level -Update on Prevalence and Characteristics

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04901845
• Other study ID #: IC4-05682-009-GEO
• Status: Not yet recruiting
• Start date: May 2021
• Est. completion date: September 2021

Study information

• Verified date: May 2021
• Source: Bokhua Memorial Cardiovascular Center
• Contact: Mamuka Bokuchava, MD, PhD
• Phone: +995577434075
• Email: bmamuka[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10000
• Est. completion date: September 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age above 18 years

• Patient consented to participate

Exclusion Criteria:

• Patient applying due to emergency situation

Related Conditions & MeSH terms

• Chronic Venous Disease

Intervention

Other:
• No intervention provided
Study is provided in the usual daily practice of the physicians without interventions made in their practice

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bokhua Memorial Cardiovascular Center	Chapidze Emergency Cardiology Center

References & Publications (4)

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. — View Citation

Nicolaides A, Kakkos S, Baekgaard N, Comerota A, de Maeseneer M, Eklof B, Giannoukas AD, Lugli M, Maleti O, Myers K, Nelzén 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of CVD	Percent of CVD symptomatic patients among patients applying to consultation for any reason	2 weeks
Primary	Distribution of CEAP stages	Percent of CVD patients with various CEAP stages	2 weeks
Primary	Prevalence of risk-factors associated with CVD	Frequency of risk-factors associated with CVD	2 weeks
Primary	Management tactics	Tactics chosen by physicians to manage CVD	2 weeks