Color Doppler U/S vs MSCT Venography in May-Thurner Syndrome
USvsCTV
1 other identifier
observational
25
0 countries
N/A
Brief Summary
May-Thurner syndrome is the result of compression of the left common iliac vein between the right common iliac artery and overlying vertebrae. In This Study , We will detect the role of color doppler US in the diagnosis of May-Thurner Syndrome in comparison to Direct CT Venography
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2017
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2017
CompletedFirst Posted
Study publicly available on registry
August 28, 2017
CompletedStudy Start
First participant enrolled
October 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2018
CompletedAugust 28, 2017
August 1, 2017
1.1 years
August 24, 2017
August 24, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Color Doppler U/S Vs MSCT Venography in the diagnosis of May-Thurner Syndrome
Determine the sensitivity, specificity and accuracy of non invasive color doppler ultrasound, using direct and indirect ultrasonographic signs, in the diagnosis of May-Thurner Syndrome , considering direct CT Venography as the gold standard for this diagnosis.
1 year
Eligibility Criteria
All Patients suffering from advanced chronic venous insufficiency in the left leg.
You may qualify if:
- advanced chronic venous insufficiency submitted to clinical treatment for at least 1 year with no response.
- Subject must be \> 18 and \< 80 years of age.
- informed consent document before the planned procedure.
- On duplex ultrasound: patent common femoral vein, and patent deep femoral vein, and/or femoral vein of the study leg.
You may not qualify if:
- Previous venous stent implantation involving the study leg or inferior vena cava
- Previous venovenous bypass surgery involving the study leg
- Known reaction or sensitivity to iodinated contrast that cannot be managed with premedication.
- Subjects who are pregnant (women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment).
- Acute deep venous thrombosis involving either leg.
- Known history of chronic total occlusion of the common femoral vein of the study leg.
- Venous compression caused by tumor encasement.
- Venous outflow obstruction caused by tumor thrombus.
- Elevated baseline blood creatinine (value greater than the upper limit of the normal range).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mohamed Koraim, Ass. Prof.
Assiut university, Egypt
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident Doctor
Study Record Dates
First Submitted
August 24, 2017
First Posted
August 28, 2017
Study Start
October 1, 2017
Primary Completion
October 31, 2018
Study Completion
December 30, 2018
Last Updated
August 28, 2017
Record last verified: 2017-08