Prevalence of MTHFR Polymorphisms in Venous Disease

Thrombosis Clinical Trial

— MTHFR  

Official title:

Prevalence of MTHFR Polymorphisms in Venous Disease With or Without Concomitant Thrombosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01993914
• Other study ID #: R2011-2104
• Status: Completed
• Phase: N/A
• First received: November 19, 2013
• Last updated: November 14, 2014
• Start date: February 2011
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: Health Diagnostic Laboratory, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The etiologies of varicose veins and the progression to more serious forms of chronic venous disease and identification of appropriate diagnostic tests to better aid patient management by identifying individuals who may benefit from more aggressive treatment and/ or prophylactic measures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 or over

• No venous disease (N=30); or C2-C3 venous disease (N=30); or C4-C6 venous disease (N=30)

Exclusion Criteria:

• Pregnancy

• Cancer

• Chronic obstructive pulmonary disease (COPD)

• Any systemic inflammatory disease

• Any of the following within the previous 30 days:

• Trauma

• Any surgery

• Periods of prolonged inactivity

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• MTHFR
• Thrombosis
• Varicose Veins
• Venous Disease

Locations

Country	Name	City	State
United States	The Elite Laser Vein Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Health Diagnostic Laboratory, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (10)

Ascer E, Lorensen E, Pollina RM, Gennaro M. Preliminary results of a nonoperative approach to saphenofemoral junction thrombophlebitis. J Vasc Surg. 1995 Nov;22(5):616-21. — View Citation

Binder B, Lackner HK, Salmhofer W, Kroemer S, Custovic J, Hofmann-Wellenhof R. Association between superficial vein thrombosis and deep vein thrombosis of the lower extremities. Arch Dermatol. 2009 Jul;145(7):753-7. doi: 10.1001/archdermatol.2009.123. — View Citation

Campbell B. Varicose veins and their management. BMJ. 2006 Aug 5;333(7562):287-92. Review. — View Citation

Caprini JA, Goldshteyn S, Glase CJ, Hathaway K. Thrombophilia testing in patients with venous thrombosis. Eur J Vasc Endovasc Surg. 2005 Nov;30(5):550-5. Epub 2005 Aug 1. — View Citation

Chengelis DL, Bendick PJ, Glover JL, Brown OW, Ranval TJ. Progression of superficial venous thrombosis to deep vein thrombosis. J Vasc Surg. 1996 Nov;24(5):745-9. — View Citation

Jorgensen JO, Hanel KC, Morgan AM, Hunt JM. The incidence of deep venous thrombosis in patients with superficial thrombophlebitis of the lower limbs. J Vasc Surg. 1993 Jul;18(1):70-3. — View Citation

Krijnen RM, de Boer EM, Bruynzeel DP. Epidemiology of venous disorders in the general and occupational populations. Epidemiol Rev. 1997;19(2):294-309. Review. — View Citation

Leon L, Giannoukas AD, Dodd D, Chan P, Labropoulos N. Clinical significance of superficial vein thrombosis. Eur J Vasc Endovasc Surg. 2005 Jan;29(1):10-7. Review. — View Citation

Sverdlova AM, Bubnova NA, Baranovskaya SS, Vasina VI, Avitisjan AO, Schwartz EI. Prevalence of the methylenetetrahydrofolate reductase (MTHFR) C677T mutation in patients with varicose veins of lower limbs. Mol Genet Metab. 1998 Jan;63(1):35-6. — View Citation

Wilmanns C, Casey A, Schinzel H, Walter PK. Superficial thrombophlebitis in varicose vein disease: the particular role of methylenetetrahydrofolate reductase. Phlebology. 2011 Jun;26(4):135-9. doi: 10.1258/phleb.2009.009075. Epub 2010 Sep 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of MTHFR mutation between patients	Determine whether the prevalence of the MTHFR mutation differs between patient with varicose veins compared to controls and with or without superficial vein thrombosis.	Baseline	No