Clinical trial NCT01993914: Prevalence of MTHFR Polymorphisms in Venous Disease
Official title: Prevalence of MTHFR Polymorphisms in Venous Disease With or Without Concomitant Thrombosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Varicose Veins
MTHFR
Venous Disease
Thrombosis
Lead sponsor: Health Diagnostic Laboratory, Inc.
Sponsor class: INDUSTRY
First posted: 2013-11-25
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from the Elite Laser Vein Center, representative of the ethnic population of Los Angeles, CA, estimated as 40% Non Hispanic White, 40% Hispanic, 10% African American, 10% Asian.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of MTHFR mutation between patients
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: The Elite Laser Vein Center
state: California
Study officials:
name: Michael Richman, MD,FACS,FCCP
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1006/mgme.1997.2638. No abstract available.
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.
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. doi: 10.1093/oxfordjournals.epirev.a017959. No abstract available.
citation: Campbell B. Varicose veins and their management. BMJ. 2006 Aug 5;333(7562):287-92. doi: 10.1136/bmj.333.7562.287. No abstract available.
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. doi: 10.1067/mva.1993.42072.
citation: 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. doi: 10.1016/s0741-5214(95)70049-8.
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. doi: 10.1016/s0741-5214(96)70007-1.
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. doi: 10.1016/j.ejvs.2004.09.021.
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.
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. doi: 10.1016/j.ejvs.2005.05.034. Epub 2005 Aug 1.