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Prevalence of MTHFR Polymorphisms in Venous Disease

NCT ID: NCT01993914

Last Updated: 2014-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2014-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Varicose Veins MTHFR Venous Disease Thrombosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Health Diagnostic Laboratory, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Richman, MD,FACS,FCCP

Role: PRINCIPAL_INVESTIGATOR

Locations

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The Elite Laser Vein Center

Los Angeles, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 9538515 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20881312 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9494789 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16888305 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8326661 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7494365 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8918318 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15570265 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19620555 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16055356 (View on PubMed)

Other Identifiers

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R2011-2104

Identifier Type: -

Identifier Source: org_study_id