Clincosm LogoSign in Get a demo

MTSS: Prevalence of May-Thurner Syndrome in 1st-degree Relatives of Symptomatic Patients

Sponsor
University Hospital of Limerick (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05409781
Collaborator
(none)
50
Enrollment
6
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The aim is to assess the prevalence of May-Thurner syndrome in 1st-degree relatives of previously identified symptomatic patients.

Condition or Disease Intervention/Treatment Phase
  • Other: No Intervention

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
50 participants
Observational Model:
Case-Crossover
Time Perspective:
Prospective
Official Title:
Prevalence of May-Thurner Syndrome in 1st-degree Relatives of Symptomatic Patients
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Jan 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Prevalence Assessment [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

Secondary Outcome Measures

  1. Venous Competence Assessment [1 year]

    To assess concomitant venous incompetence of the lower limb

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital of Limerick

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fiona Leahy, Research Nurse Manager, University Hospital of Limerick
ClinicalTrials.gov Identifier:
NCT05409781
Other Study ID Numbers:
  • DVS002
First Posted:
Jun 8, 2022
Last Update Posted:
Jun 28, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
May-Thurner Syndrome
Syndrome

Study Results

No Results Posted as of Jun 28, 2022