Prevalence of MTHFR Polymorphisms in Venous Disease (MTHFR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01993914
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : November 17, 2014
Information provided by (Responsible Party):
Health Diagnostic Laboratory, Inc.

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.

Condition or disease
Varicose Veins MTHFR Venous Disease Thrombosis

Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Prevalence of MTHFR Polymorphisms in Venous Disease With or Without Concomitant Thrombosis
Study Start Date : February 2011
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Prevalence of MTHFR mutation between patients [ Time Frame: Baseline ]
    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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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


Responsible Party: Health Diagnostic Laboratory, Inc. Identifier: NCT01993914     History of Changes
Other Study ID Numbers: R2011-2104
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: November 17, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Varicose Veins
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases