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Prevalence of MTHFR Polymorphisms in Venous Disease (MTHFR)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01993914
First Posted: November 25, 2013
Last Update Posted: November 17, 2014
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.
Information provided by (Responsible Party):
Health Diagnostic Laboratory, Inc.
  Purpose
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
Varicose Veins MTHFR Venous Disease Thrombosis

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 ]
    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)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01993914


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

Publications:

Responsible Party: Health Diagnostic Laboratory, Inc.
ClinicalTrials.gov Identifier: NCT01993914     History of Changes
Other Study ID Numbers: R2011-2104
First Submitted: November 19, 2013
First Posted: November 25, 2013
Last Update Posted: November 17, 2014
Last Verified: November 2014

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