Prevalence of MTHFR Polymorphisms in Venous Disease (MTHFR)

November 14, 2014 updated by: Health Diagnostic Laboratory, Inc.

Prevalence of MTHFR Polymorphisms in Venous Disease With or Without Concomitant Thrombosis

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90025
        • The Elite Laser Vein Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Health Diagnostic Laboratory, Inc.

Investigators

  • Principal Investigator: Michael Richman, MD,FACS,FCCP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

November 19, 2013

First Submitted That Met QC Criteria

November 19, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Estimate)

November 17, 2014

Last Update Submitted That Met QC Criteria

November 14, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R2011-2104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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