Prevalence of MTHFR Polymorphisms in Venous Disease

This study has been completed.
Information provided by (Responsible Party):
Health Diagnostic Laboratory, Inc. Identifier:
First received: November 19, 2013
Last updated: November 14, 2014
Last verified: November 2014

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.

Varicose Veins
Venous Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Prevalence of MTHFR Polymorphisms in Venous Disease With or Without Concomitant Thrombosis

Resource links provided by NLM:

Further study details as provided by Health Diagnostic Laboratory, Inc.:

Primary Outcome Measures:
  • Prevalence of MTHFR mutation between patients [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Determine whether the prevalence of the MTHFR mutation differs between patient with varicose veins compared to controls and with or without superficial vein thrombosis.

Biospecimen Retention:   Samples With DNA

Whole blood and serum

Enrollment: 90
Study Start Date: February 2011
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.


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
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Please refer to this study by its identifier: NCT01993914

United States, California
The Elite Laser Vein Center
Los Angeles, California, United States, 90025
Sponsors and Collaborators
Health Diagnostic Laboratory, Inc.
Principal Investigator: Michael Richman, MD,FACS,FCCP
  More Information


Responsible Party: Health Diagnostic Laboratory, Inc. Identifier: NCT01993914     History of Changes
Other Study ID Numbers: R2011-2104
Study First Received: November 19, 2013
Last Updated: November 14, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Varicose Veins
Cardiovascular Diseases
Embolism and Thrombosis
Vascular Diseases processed this record on October 06, 2015