<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03262987</url>
  </required_header>
  <id_info>
    <org_study_id>May-Thurner Syndrome</org_study_id>
    <nct_id>NCT03262987</nct_id>
  </id_info>
  <brief_title>Color Doppler U/S vs MSCT Venography in May-Thurner Syndrome</brief_title>
  <acronym>USvsCTV</acronym>
  <official_title>Color Doppler U/S vs MSCT Venography in the Diagnosis of May-Thurner Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      May-Thurner syndrome is the result of compression of the left common iliac vein between the&#xD;
      right common iliac artery and overlying vertebrae.&#xD;
&#xD;
      In This Study , We will detect the role of color doppler US in the diagnosis of May-Thurner&#xD;
      Syndrome in comparison to Direct CT Venography&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      May-Thurner syndrome (MTS) is a venous compression syndrome in which the left common iliac&#xD;
      vein is compressed between the lower lumbar spine and the right common iliac artery. While&#xD;
      asymptomatic compression is very common, the process can lead to morbidity in selected&#xD;
      individuals, most commonly deep venous thrombosis (DVT) and the sequelae thereof.&#xD;
      Radiologists must recognize the diagnosis because of the unique management, which differs&#xD;
      from DVT without iliac vein compression.&#xD;
&#xD;
      The most common clinical presentation is unilateral leg swelling due to acute DVT. It can&#xD;
      also present as chronic venous insufficiency or chronic thrombosis with symptoms of venous&#xD;
      hypertension and venous stasis namely claudication, pain, swelling, varicose veins and / or&#xD;
      ulceration.&#xD;
&#xD;
      Conventional invasive catheter venography remains the gold standard for diagnosis,but the&#xD;
      decision to undertake invasive venography should be made only after reviewing all available&#xD;
      clinical data and alternative, less invasive imaging options have been exhausted.&#xD;
&#xD;
      When visualization of the common iliac veins is possible, MTS may be diagnosed with&#xD;
      transabdominal color Doppler U/S.&#xD;
&#xD;
      MDCT with IV contrast is a fast, widely available examination for the diagnosis of MTS and&#xD;
      accompanying complications .&#xD;
&#xD;
      Magnetic resonance imaging (MRI) with MR venography is an attractive modality for the&#xD;
      diagnosis, However, MRI is expensive, time consuming, has more limited availability than&#xD;
      computed tomography (CT) and ultrasound, and may be impossible in select patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2018</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Color Doppler U/S Vs MSCT Venography in the diagnosis of May-Thurner Syndrome</measure>
    <time_frame>1 year</time_frame>
    <description>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.</description>
  </primary_outcome>
  <enrollment type="Anticipated">25</enrollment>
  <condition>May-Thurner Syndrome</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All Patients suffering from advanced chronic venous insufficiency in the left leg.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  advanced chronic venous insufficiency submitted to clinical treatment for at least 1&#xD;
             year with no response.&#xD;
&#xD;
          -  Subject must be &gt; 18 and &lt; 80 years of age.&#xD;
&#xD;
          -  informed consent document before the planned procedure.&#xD;
&#xD;
          -  On duplex ultrasound: patent common femoral vein, and patent deep femoral vein, and/or&#xD;
             femoral vein of the study leg.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous venous stent implantation involving the study leg or inferior vena cava&#xD;
&#xD;
          -  Previous venovenous bypass surgery involving the study leg&#xD;
&#xD;
          -  Known reaction or sensitivity to iodinated contrast that cannot be managed with&#xD;
             premedication.&#xD;
&#xD;
          -  Subjects who are pregnant (women of childbearing potential must have a negative&#xD;
             pregnancy test within 7 days prior to enrollment).&#xD;
&#xD;
          -  Acute deep venous thrombosis involving either leg.&#xD;
&#xD;
          -  Known history of chronic total occlusion of the common femoral vein of the study leg.&#xD;
&#xD;
          -  Venous compression caused by tumor encasement.&#xD;
&#xD;
          -  Venous outflow obstruction caused by tumor thrombus.&#xD;
&#xD;
          -  Elevated baseline blood creatinine (value greater than the upper limit of the normal&#xD;
             range).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohamed Koraim, Ass. Prof.</last_name>
    <role>Study Chair</role>
    <affiliation>Assiut university, Egypt</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Omar Mokhtar, M.B.B.CH</last_name>
    <phone>+201094584576</phone>
    <email>ogamalm2217@gmail.com</email>
  </overall_contact>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>August 24, 2017</last_update_submitted>
  <last_update_submitted_qc>August 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Omar Gamal Mokhtar</investigator_full_name>
    <investigator_title>Resident Doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>May-Thurner Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>to be shared when finished</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03262987
org study id: May-Thurner Syndrome
nct id: NCT03262987
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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
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.
observational model: Cohort
time perspective: Prospective
measure: Color Doppler U/S Vs MSCT Venography in the diagnosis of May-Thurner Syndrome
time frame: 1 year
description: 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.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Mohamed Koraim, Ass. Prof.
role: Study Chair
affiliation: Assiut university, Egypt
last name: Omar Mokhtar, M.B.B.CH
phone: +201094584576
email: ogamalm2217@gmail.com
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Omar Gamal Mokhtar
investigator title: Resident Doctor
mesh term: May-Thurner Syndrome
mesh term: Syndrome
sharing ipd: Undecided
ipd description: to be shared when finished