Varicose VeinsMTHFRNCT01993914
Prevalence of MTHFR Polymorphisms in Venous Disease
An observational study of Varicose Veins and MTHFR, run by Health Diagnostic Laboratory, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Varicose Veins, MTHFR, Venous Disease
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Age 18 or over
- No venous disease (N=30); or C2-C3 venous disease (N=30); or C4-C6 venous disease (N=30)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Elite Laser Vein Center
Los Angeles, California, 90025
About this study
Official title: 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.
- Conditions
- Varicose Veins, MTHFR, Venous Disease, Thrombosis
- Medical subject headings
- Varicose Veins, Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of MTHFR mutation between patients
Determine whether the prevalence of the MTHFR mutation differs between patient with varicose veins compared to controls and with or without superficial vein thrombosis.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startFeb 2011
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health Diagnostic Laboratory, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Richman, MD,FACS,FCCP, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993914
- Sponsor's protocol ID
- R2011-2104
- Acronym
- MTHFR
- Status last verified
- Nov 2014
- First submitted
- 19 Nov 2013
- Last updated
- 17 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Sverdlova AM, Bubnova NA, Baranovskaya SS, Vasina VI, Avitisjan AO, Schwartz EI. Prevalence of the methylenetetrahydrofolate reductase (MTHFR) C677T mutation in patients with varicose veins of lower limbs. Mol Genet Metab. 1998 Jan;63(1):35-6. doi: 10.1006/mgme.1997.2638. No abstract available.
PubMed 9538515Wilmanns C, Casey A, Schinzel H, Walter PK. Superficial thrombophlebitis in varicose vein disease: the particular role of methylenetetrahydrofolate reductase. Phlebology. 2011 Jun;26(4):135-9. doi: 10.1258/phleb.2009.009075. Epub 2010 Sep 29.
PubMed 20881312Krijnen RM, de Boer EM, Bruynzeel DP. Epidemiology of venous disorders in the general and occupational populations. Epidemiol Rev. 1997;19(2):294-309. doi: 10.1093/oxfordjournals.epirev.a017959. No abstract available.
PubMed 9494789Campbell B. Varicose veins and their management. BMJ. 2006 Aug 5;333(7562):287-92. doi: 10.1136/bmj.333.7562.287. No abstract available.
PubMed 16888305Jorgensen JO, Hanel KC, Morgan AM, Hunt JM. The incidence of deep venous thrombosis in patients with superficial thrombophlebitis of the lower limbs. J Vasc Surg. 1993 Jul;18(1):70-3. doi: 10.1067/mva.1993.42072.
PubMed 8326661Ascer E, Lorensen E, Pollina RM, Gennaro M. Preliminary results of a nonoperative approach to saphenofemoral junction thrombophlebitis. J Vasc Surg. 1995 Nov;22(5):616-21. doi: 10.1016/s0741-5214(95)70049-8.
PubMed 7494365Chengelis DL, Bendick PJ, Glover JL, Brown OW, Ranval TJ. Progression of superficial venous thrombosis to deep vein thrombosis. J Vasc Surg. 1996 Nov;24(5):745-9. doi: 10.1016/s0741-5214(96)70007-1.
PubMed 8918318Leon L, Giannoukas AD, Dodd D, Chan P, Labropoulos N. Clinical significance of superficial vein thrombosis. Eur J Vasc Endovasc Surg. 2005 Jan;29(1):10-7. doi: 10.1016/j.ejvs.2004.09.021.
PubMed 15570265Binder B, Lackner HK, Salmhofer W, Kroemer S, Custovic J, Hofmann-Wellenhof R. Association between superficial vein thrombosis and deep vein thrombosis of the lower extremities. Arch Dermatol. 2009 Jul;145(7):753-7. doi: 10.1001/archdermatol.2009.123.
PubMed 19620555Caprini JA, Goldshteyn S, Glase CJ, Hathaway K. Thrombophilia testing in patients with venous thrombosis. Eur J Vasc Endovasc Surg. 2005 Nov;30(5):550-5. doi: 10.1016/j.ejvs.2005.05.034. Epub 2005 Aug 1.
PubMed 16055356
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of MTHFR Polymorphisms in Venous Disease With or Without Concomitant Thrombosis
- ClinicalTrials.gov ID
- NCT01993914
- Acronym / sponsor ID
- MTHFR / R2011-2104
- Conditions
- Varicose Veins, MTHFR, Venous Disease, Thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Health Diagnostic Laboratory, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Age 18 or over
- No venous disease (N=30); or C2-C3 venous disease (N=30); or C4-C6 venous disease (N=30)
Key exclusion criteria (8 listed)
- Pregnancy
- Cancer
- Chronic obstructive pulmonary disease (COPD)
- Any systemic inflammatory disease
- Any of the following within the previous 30 days:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2014.
- Background: PubMed 9538515Sverdlova AM, Bubnova NA, Baranovskaya SS, Vasina VI, Avitisjan AO, Schwartz EI. Prevalence of the methylenetetrahydrofolate reductase (MTHFR) C677T mutation in patients with varicose veins of lower limbs. Mol Genet Metab. 1998 Jan;63(1):35-6. doi: 10.1006/mgme.1997.2638. No abstract available.
- Background: PubMed 20881312Wilmanns C, Casey A, Schinzel H, Walter PK. Superficial thrombophlebitis in varicose vein disease: the particular role of methylenetetrahydrofolate reductase. Phlebology. 2011 Jun;26(4):135-9. doi: 10.1258/phleb.2009.009075. Epub 2010 Sep 29.
- Background: PubMed 9494789Krijnen RM, de Boer EM, Bruynzeel DP. Epidemiology of venous disorders in the general and occupational populations. Epidemiol Rev. 1997;19(2):294-309. doi: 10.1093/oxfordjournals.epirev.a017959. No abstract available.
- Background: PubMed 16888305Campbell B. Varicose veins and their management. BMJ. 2006 Aug 5;333(7562):287-92. doi: 10.1136/bmj.333.7562.287. No abstract available.
- Background: PubMed 8326661Jorgensen JO, Hanel KC, Morgan AM, Hunt JM. The incidence of deep venous thrombosis in patients with superficial thrombophlebitis of the lower limbs. J Vasc Surg. 1993 Jul;18(1):70-3. doi: 10.1067/mva.1993.42072.
- Background: PubMed 7494365Ascer E, Lorensen E, Pollina RM, Gennaro M. Preliminary results of a nonoperative approach to saphenofemoral junction thrombophlebitis. J Vasc Surg. 1995 Nov;22(5):616-21. doi: 10.1016/s0741-5214(95)70049-8.
- Background: PubMed 8918318Chengelis DL, Bendick PJ, Glover JL, Brown OW, Ranval TJ. Progression of superficial venous thrombosis to deep vein thrombosis. J Vasc Surg. 1996 Nov;24(5):745-9. doi: 10.1016/s0741-5214(96)70007-1.
- Background: PubMed 15570265Leon L, Giannoukas AD, Dodd D, Chan P, Labropoulos N. Clinical significance of superficial vein thrombosis. Eur J Vasc Endovasc Surg. 2005 Jan;29(1):10-7. doi: 10.1016/j.ejvs.2004.09.021.
- Background: PubMed 19620555Binder B, Lackner HK, Salmhofer W, Kroemer S, Custovic J, Hofmann-Wellenhof R. Association between superficial vein thrombosis and deep vein thrombosis of the lower extremities. Arch Dermatol. 2009 Jul;145(7):753-7. doi: 10.1001/archdermatol.2009.123.
- Background: PubMed 16055356Caprini JA, Goldshteyn S, Glase CJ, Hathaway K. Thrombophilia testing in patients with venous thrombosis. Eur J Vasc Endovasc Surg. 2005 Nov;30(5):550-5. doi: 10.1016/j.ejvs.2005.05.034. Epub 2005 Aug 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Richman, MD,FACS,FCCP principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Varicose Veins and MTHFR, run by Health Diagnostic Laboratory, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of MTHFR mutation between patients (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01993914, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2014.