xml: <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/NCT06025591</url>
    </required_header>
    <id_info>
      <org_study_id>5833</org_study_id>
      <nct_id>NCT06025591</nct_id>
    </id_info>
    <brief_title>Shear-Wave Elastography in Deep Vein Thrombosis</brief_title>
    <acronym>SWE-DVT</acronym>
    <official_title>Role of Ultrasound Elastography in Distinction Between Acute and Chronic Deep Vein Thrombosis: a Prospective Observational Cohort Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Compression ultrasonography (CUS), which is the gold-standard for the diagnosis of deep vein&#xD;
        thrombosis, cannot provide adequate information on the timing of the onset of thrombosis.&#xD;
        Shear-Wave elastography, a technique used to assess tissue elasticity and widely used in&#xD;
        hepatology, could play a crucial role in distinguishing between acute and chronic deep vein&#xD;
        thrombosis.&#xD;
  &#xD;
        This study aims at evaluating the efficacy and diagnostic and prognostic accuracy of&#xD;
        Shear-Wave elastography in distinguishing between acute and chronic deep vein thrombosis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Compression ultrasonography (CUS), supplemented with color-Doppler, is the gold-standard for&#xD;
        the diagnosis of deep vein thrombosis. However, it cannot provide adequate information on the&#xD;
        timing of the onset of thrombosis, thus not allowing a distinction between acute and chronic&#xD;
        venous thrombosis. A few non-standardized and poorly reproducible criteria are used in&#xD;
        clinical practice, such as thrombus echogenicity, degree of occlusion and signs of&#xD;
        recanalization. The importance of the distinction between acute and chronic venous thrombosis&#xD;
        has therapeutic and prognostic implications, especially in patients with occasional and&#xD;
        asymptomatic finding of venous thrombosis or in patients with suspected thrombotic recurrence&#xD;
        in whom signs and symptoms may be either due to a post-thrombotic syndrome or to a new&#xD;
        thrombotic episode.&#xD;
  &#xD;
        Shear-Wave elastography, a technique used to assess tissue elasticity and widely used in&#xD;
        hepatology, could play a crucial role in distinguishing between acute and chronic deep vein&#xD;
        thrombosis. Literature data on the use of this technique in the evaluation of deep venous&#xD;
        thrombosis are derived only from observational studies, both retrospective and prospective,&#xD;
        mainly based on comparisons between different groups of patients with acute (within 72h from&#xD;
        diagnosis) or subacute thrombosis at a 3-months follow-up, with the consequent risk of&#xD;
        confounding in the estimating the association of elasticity values to the dating of&#xD;
        thrombotic remnant. The few data in the literature on thrombus evolution, assessed by&#xD;
        single-patient serialized evaluation, refer to extremely limited case series with short&#xD;
        follow-up. In addition, none of these studies consider neoplastic patients, on whom there are&#xD;
        no data regarding the usefulness and reproducibility of the method. In accordance with&#xD;
        current clinical practice, patients referred to our service of Internal medicine and&#xD;
        Thromboembolic Pathology perform ultrasound follow-up so that the evolution of thrombotic&#xD;
        residual can be assessed on each patient with large case series and follow-up of longer&#xD;
        duration. The primary objective of the present study is to evaluate the efficacy and&#xD;
        diagnostic and prognostic accuracy of Shear-Wave elastography in distinguishing between acute&#xD;
        and chronic deep vein thrombosis.&#xD;
  &#xD;
        Secondary objectives:&#xD;
  &#xD;
          -  Evaluation of the maximum thickness of the thrombotic residue in compression, as well as&#xD;
             the longitudinal extent by B-mode ultrasound method, expressed in mm, at the various&#xD;
             time-points of the study&#xD;
  &#xD;
          -  Evaluation of the degree of venous obstruction, assessed by color-Doppler ultrasound&#xD;
             method at the various time-points of the study&#xD;
  &#xD;
          -  Qualitative evaluation of the echogenicity of the thrombotic remnant, by B-mode&#xD;
             ultrasound method in comparison with the echogenicity of the surrounding muscle and&#xD;
             vascular structures, at the various time-points of the study.&#xD;
  &#xD;
          -  Identification of a specific signature for recanalization of deep vein thrombosis of the&#xD;
             lower and upper limbs&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2025</completion_date>
    <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Fibrosis Index</measure>
      <time_frame>1 month</time_frame>
      <description>Evaluation of a potential time-dependent cut-off of Fibrosis Index discriminating between acute (within 72h) and chronic (3-6-9-12 months) thrombosis.</description>
    </primary_outcome>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Deep Vein Thrombosis</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Subjects with newly diagnosed deep venous thrombosis of the lower and upper extremities&#xD;
          afferent to the Operating Units of Fondazione Policlinico Universitario Agostino Gemelli&#xD;
          IRCSS involved in the study (i.e. Medical Angiology Service, Internal Medicine and&#xD;
          Thromboembolic Pathologies and Outpatient Clinic of Internal Medicine and Gastroenterology&#xD;
          of the C.E.M.A.D. - Center for Diseases of the Digestive System),who will meet the&#xD;
          inclusion criteria.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18 years;&#xD;
  &#xD;
            -  New diagnosis of proximal deep venous thrombosis, Distal deep venous thrombosis of the&#xD;
               lower limbs, deep venous thrombosis of the upper limbs, defined as arising within 72&#xD;
               hours prior to the first ultrasound evaluation;&#xD;
  &#xD;
            -  Availability for follow-up at the above-mentioned Units in Fondazione Policlinico&#xD;
               Universitario Agostino Gemelli IRCSS.;&#xD;
  &#xD;
            -  written informed consent to the participation in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age &lt;18 years;&#xD;
  &#xD;
            -  Pregnant or lactating women;&#xD;
  &#xD;
            -  Life expectancy of less than 6 months;&#xD;
  &#xD;
            -  Previous performance of drug-mechanical thrombolysis for the treatment of index&#xD;
               thrombotic episode;&#xD;
  &#xD;
            -  Technical impossibility/clinical unreliability of ultrasound evaluation with&#xD;
               elastography due to: (a) obligate decubitus of the patient's limb, (b) non-removable&#xD;
               occluding dressings, (c) excessive thickness of subcutaneous fatty tissue or edema;&#xD;
  &#xD;
            -  Previous thrombotic episode at the same site of the thromboembolic episode under&#xD;
               study.&#xD;
  &#xD;
            -  Refusal to sign informed consent to participate in the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Maria Assunta Zocco</last_name>
      <phone>00393470597805</phone>
      <email>mariaassunta.zocco@policlinicogemelli.it</email>
    </overall_contact>
    <location>
      <facility>
        <name>Fondazione Policlinico Gemelli IRCCS</name>
        <address>
          <city>Roma</city>
          <zip>00168</zip>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</investigator_affiliation>
      <investigator_full_name>Zocco Maria Assunta</investigator_full_name>
      <investigator_title>Prof</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Thrombosis</mesh_term>
      <mesh_term>Venous Thrombosis</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06025591
  org study id: 5833
  nct id: NCT06025591
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Compression ultrasonography (CUS), which is the gold-standard for the diagnosis of deep vein
        thrombosis, cannot provide adequate information on the timing of the onset of thrombosis.
        Shear-Wave elastography, a technique used to assess tissue elasticity and widely used in
        hepatology, could play a crucial role in distinguishing between acute and chronic deep vein
        thrombosis.
  
        This study aims at evaluating the efficacy and diagnostic and prognostic accuracy of
        Shear-Wave elastography in distinguishing between acute and chronic deep vein thrombosis.
  Compression ultrasonography (CUS), supplemented with color-Doppler, is the gold-standard for
        the diagnosis of deep vein thrombosis. However, it cannot provide adequate information on the
        timing of the onset of thrombosis, thus not allowing a distinction between acute and chronic
        venous thrombosis. A few non-standardized and poorly reproducible criteria are used in
        clinical practice, such as thrombus echogenicity, degree of occlusion and signs of
        recanalization. The importance of the distinction between acute and chronic venous thrombosis
        has therapeutic and prognostic implications, especially in patients with occasional and
        asymptomatic finding of venous thrombosis or in patients with suspected thrombotic recurrence
        in whom signs and symptoms may be either due to a post-thrombotic syndrome or to a new
        thrombotic episode.
  
        Shear-Wave elastography, a technique used to assess tissue elasticity and widely used in
        hepatology, could play a crucial role in distinguishing between acute and chronic deep vein
        thrombosis. Literature data on the use of this technique in the evaluation of deep venous
        thrombosis are derived only from observational studies, both retrospective and prospective,
        mainly based on comparisons between different groups of patients with acute (within 72h from
        diagnosis) or subacute thrombosis at a 3-months follow-up, with the consequent risk of
        confounding in the estimating the association of elasticity values to the dating of
        thrombotic remnant. The few data in the literature on thrombus evolution, assessed by
        single-patient serialized evaluation, refer to extremely limited case series with short
        follow-up. In addition, none of these studies consider neoplastic patients, on whom there are
        no data regarding the usefulness and reproducibility of the method. In accordance with
        current clinical practice, patients referred to our service of Internal medicine and
        Thromboembolic Pathology perform ultrasound follow-up so that the evolution of thrombotic
        residual can be assessed on each patient with large case series and follow-up of longer
        duration. The primary objective of the present study is to evaluate the efficacy and
        diagnostic and prognostic accuracy of Shear-Wave elastography in distinguishing between acute
        and chronic deep vein thrombosis.
  
        Secondary objectives:
  
          -  Evaluation of the maximum thickness of the thrombotic residue in compression, as well as
             the longitudinal extent by B-mode ultrasound method, expressed in mm, at the various
             time-points of the study
  
          -  Evaluation of the degree of venous obstruction, assessed by color-Doppler ultrasound
             method at the various time-points of the study
  
          -  Qualitative evaluation of the echogenicity of the thrombotic remnant, by B-mode
             ultrasound method in comparison with the echogenicity of the surrounding muscle and
             vascular structures, at the various time-points of the study.
  
          -  Identification of a specific signature for recanalization of deep vein thrombosis of the
             lower and upper limbs
  observational model: Case-Only
  time perspective: Prospective
  measure: Fibrosis Index
  time frame: 1 month
  description: Evaluation of a potential time-dependent cut-off of Fibrosis Index discriminating between acute (within 72h) and chronic (3-6-9-12 months) thrombosis.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Maria Assunta Zocco
  phone: 00393470597805
  email: mariaassunta.zocco@policlinicogemelli.it
  facility: 
  country: Italy
  responsible party type: Principal Investigator
  investigator affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  investigator full name: Zocco Maria Assunta
  investigator title: Prof
  mesh term: Thrombosis
  mesh term: Venous Thrombosis