Prevalence of MTHFR Polymorphisms in Venous Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Health Diagnostic Laboratory, Inc.
Sponsor:
Information provided by (Responsible Party):
Health Diagnostic Laboratory, Inc.
ClinicalTrials.gov Identifier:
NCT01993914
First received: November 19, 2013
Last updated: August 18, 2014
Last verified: August 2014
  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 ] [ 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


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

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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01993914

Contacts
Contact: Stephen Varvel, PhD 804-343-2718 ext 2231 svarvel@hdlabinc.com
Contact: Monique Alston, LPN 804-343-2718 ext 2210 malston@hdlabinc.com

Locations
United States, California
The Elite Laser Vein Center Recruiting
Los Angeles, California, United States, 90025
Contact: Lindsay Winkelman, RD    877-443-5227 ext 276    lwinkelman@hdlabinc.com   
Principal Investigator: Michael Richman, MD,FACS,FCCP         
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
Study First Received: November 19, 2013
Last Updated: August 18, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 21, 2014