- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05409781
Prevalence of May-Thurner Syndrome in 1st-degree Relatives of Symptomatic Patients (MTS)
Study Overview
Detailed Description
May-Thurner syndrome (MTS) is a condition characterised by compression of the left common iliac vein by the right common iliac artery and the anterior spine of the 5th lumbar vertebrae. Previously thought to be a rare condition, the prevalence of MTS is thought to be underreported. MTS can lead to significant morbidity in the form of chronic venous insufficiency, venous ulceration, lower limb swelling, venous claudication, deep-vein thrombosis, varicose veins, pelvic congestion syndrome, chronic pelvic pain and chronic post-thrombotic syndrome. It is a known risk factor for development of venous incompetence and varicose veins in adolescents and young adults. Furthermore, it is known to be an a causative factor in the development of "unprovoked" DVT in younger patients, however data on the risk of development of DVT in MTS patients has to date, been unavailable.
The pathogenesis of MTS is largely unknown and whilst the condition is known to be more prevalent in females, familial risk factors are largely unknown. To date, no studies have previously assessed the prevalence of MTS in relatives of those with the condition.
Study Type
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Informed consent, first degree relative with symptomatic May-Thurner syndrome
Exclusion Criteria:
- Those who not give informed consent to be contacted or to be scanned.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence Assessment
Time Frame: 1 year
|
To assess the prevalence of May-Thurner syndrome amongst 1st-degree relatives of symptomatic individuals referred to the Vascular Department, University Hospital Limerick using duplex ultrasound imaging
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Venous Competence Assessment
Time Frame: 1 year
|
To assess concomitant venous incompetence of the lower limb
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DVS002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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