May-Thurner SyndromeUSvsCTVNCT03262987
Color Doppler U/S vs MSCT Venography in May-Thurner Syndrome
An observational study of May-Thurner Syndrome, run by Assiut University.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- May-Thurner Syndrome
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2017to 30 Dec 2018
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All Patients suffering from advanced chronic venous insufficiency in the left leg.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Color Doppler U/S vs MSCT Venography in the Diagnosis of May-Thurner Syndrome
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
Read the detailed description
May-Thurner syndrome (MTS) is a venous compression syndrome in which the left common iliac vein is compressed between the lower lumbar spine and the right common iliac artery. While asymptomatic compression is very common, the process can lead to morbidity in selected individuals, most commonly deep venous thrombosis (DVT) and the sequelae thereof. Radiologists must recognize the diagnosis because of the unique management, which differs from DVT without iliac vein compression.
The most common clinical presentation is unilateral leg swelling due to acute DVT. It can also present as chronic venous insufficiency or chronic thrombosis with symptoms of venous hypertension and venous stasis namely claudication, pain, swelling, varicose veins and / or ulceration.
Conventional invasive catheter venography remains the gold standard for diagnosis,but the decision to undertake invasive venography should be made only after reviewing all available clinical data and alternative, less invasive imaging options have been exhausted.
When visualization of the common iliac veins is possible, MTS may be diagnosed with transabdominal color Doppler U/S.
MDCT with IV contrast is a fast, widely available examination for the diagnosis of MTS and accompanying complications .
Magnetic resonance imaging (MRI) with MR venography is an attractive modality for the diagnosis, However, MRI is expensive, time consuming, has more limited availability than computed tomography (CT) and ultrasound, and may be impossible in select patients.
- Conditions
- May-Thurner Syndrome
- Medical subject headings
- May-Thurner Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start1 Oct 2017 (estimated)
- Primary completion31 Oct 2018 (estimated)
- Study completion30 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for May-Thurner SyndromeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Gamal Mokhtar, Assiut University
- Investigators
- Mohamed Koraim, Ass. Prof., Study chair, Assiut university, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262987
- Sponsor's protocol ID
- May-Thurner Syndrome
- Acronym
- USvsCTV
- Status last verified
- Aug 2017
- First submitted
- 24 Aug 2017
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: to be shared when finished
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Color Doppler U/S vs MSCT Venography in the Diagnosis of May-Thurner Syndrome
- ClinicalTrials.gov ID
- NCT03262987
- Acronym / sponsor ID
- USvsCTV / May-Thurner Syndrome
- Conditions
- May-Thurner Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (estimated)
- Primary completion
- 31 Oct 2018 (estimated)
- Study completion
- 30 Dec 2018 (estimated)
- First posted
- 28 Aug 2017 (actual)
- 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.
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
Detailed description
May-Thurner syndrome (MTS) is a venous compression syndrome in which the left common iliac vein is compressed between the lower lumbar spine and the right common iliac artery. While asymptomatic compression is very common, the process can lead to morbidity in selected individuals, most commonly deep venous thrombosis (DVT) and the sequelae thereof. Radiologists must recognize the diagnosis because of the unique management, which differs from DVT without iliac vein compression.
The most common clinical presentation is unilateral leg swelling due to acute DVT. It can also present as chronic venous insufficiency or chronic thrombosis with symptoms of venous hypertension and venous stasis namely claudication, pain, swelling, varicose veins and / or ulceration.
Conventional invasive catheter venography remains the gold standard for diagnosis,but the decision to undertake invasive venography should be made only after reviewing all available clinical data and alternative, less invasive imaging options have been exhausted.
When visualization of the common iliac veins is possible, MTS may be diagnosed with transabdominal color Doppler U/S.
MDCT with IV contrast is a fast, widely available examination for the diagnosis of MTS and accompanying complications .
Magnetic resonance imaging (MRI) with MR venography is an attractive modality for the diagnosis, However, MRI is expensive, time consuming, has more limited availability than computed tomography (CT) and ultrasound, and may be impossible in select patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All Patients suffering from advanced chronic venous insufficiency in the left leg.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
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
Color Doppler U/S Vs MSCT Venography in the diagnosis of May-Thurner Syndrome
Time frame: 1 year
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2017.
- Individual participant dataSharing planned: Undecided. to be shared when finished
Related trials for May-Thurner Syndrome
Recruiting
Pelvic Vein Quantitative Flow Characterization Using 2D and 4D Flow MRI
May-Thurner Syndrome, Iliac Venous Compression
Not yet recruiting
Embolization of Ovarian Vein and Pelvic Venous Reservoir for Treatment of Secondary Pelvic Congestion Syndrome
Pelvic Congestion Syndrome
RecruitingObservational study
Vascular Lab Resource (VLR) Biorepository
Cardiovascular Diseases, Metabolic Disease
Recruiting
Anticoagulant Plus Antiplatelet Therapy Following Iliac Vein Stenting
Deep Vein Thrombosis, Iliac Vein Thrombosis
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.
Mohamed Koraim, Ass. Prof. study chair
Assiut university, Egypt
Questions about this trial
What is this clinical trial studying?
An observational study of May-Thurner Syndrome, run by Assiut University.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 28 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omar Mokhtar, M.B.B.CH (+201094584576, ogamalm2217@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Color Doppler U/S Vs MSCT Venography in the diagnosis of May-Thurner Syndrome (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2017.