<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/NCT02190110</url>
  </required_header>
  <id_info>
    <org_study_id>1001</org_study_id>
    <nct_id>NCT02190110</nct_id>
  </id_info>
  <brief_title>Pulmonary Embolism Diagnosis: Ultrasound Wells Score vs Traditional Wells Score</brief_title>
  <official_title>Ultrasound Wells Score vs Traditional Wells Score in the Diagnostic Approach to Pulmonary Embolism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Ospedaliero-Universitaria Careggi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda Ospedaliero-Universitaria Careggi</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pulmonary embolism (PE) should be suspected in patients with dyspnea, chest pain, syncope,&#xD;
      shock/hypotension, or cardiac arrest. Discriminating patients in different categories of&#xD;
      pre-test probability of PE has become a key step in all diagnostic algorithms for PE. The&#xD;
      most frequently used clinical prediction rule is the Wells score (&quot;PE likely&quot; &gt; 4 points and&#xD;
      &quot;PE unlikely&quot; ≤ 4 points). PE can be safely ruled out in patients with a &quot;PE unlikely&quot;&#xD;
      associated with a negative d-dimer test result. Conversely, patients with &quot;PE likely&quot; or&#xD;
      positive d-dimer level should undergo further diagnostic testing, like multidetector computed&#xD;
      tomography pulmonary angiography (MCTPA).&#xD;
&#xD;
      Wells score accuracy is not optimal. Vein and lung US can be rapidly performed at bedside as&#xD;
      an extension of physical examination and have a high specificity. The aim of this study is to&#xD;
      evaluate if the combination of clinical data reported in the Wells score and US data obtained&#xD;
      from vein and lung US (US Wells score) has a better diagnostic accuracy compared to&#xD;
      traditional Wells score.&#xD;
&#xD;
      In adult patients suspected of PE traditional Wells score will be calculated and vein and&#xD;
      lung US (multiorgan US) will be performed in all patients and and US Wells score calculated.&#xD;
      The US Wells score differs from the traditional Wells score in the following items: &quot;signs&#xD;
      and symptoms of DVT&quot;, replaced by &quot;vein US showing DVT&quot;, and &quot;alternative diagnosis less&#xD;
      likely than PE&quot; replaced by &quot;alternative diagnosis less likely than PE after multiorgan US&quot;.&#xD;
      This latter item is considered positive if at least one subpleural infarct is detected at&#xD;
      lung US, and negative if no subpleural infarcts are detected and an alternative diagnosis&#xD;
      like pneumonia, pleural effusion or diffuse interstitial syndrome may explain the symptoms of&#xD;
      presentation. If no findings are detected at lung US, the points for the item remain the same&#xD;
      assigned by traditional Wells score. Final diagnosis of PE will be preferentially established&#xD;
      by MCTPA and in patients discharged without a second level imaging test because of negative&#xD;
      Wells or d-dimer, and patients with not conclusive second level diagnostic test, will enter&#xD;
      the 3 months follow-up protocol.&#xD;
&#xD;
      The diagnostic performance of traditional and US Wells scores will be assessed by calculating&#xD;
      sensitivity, specificity, positive, and negative predictive value, and likelihood ratios.&#xD;
      Failure rate and efficacy of d-dimer in patients stratified as &quot;PE likely&quot; and &quot;PE unlikely&quot;&#xD;
      will also be calculated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</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>ultrasound Wells score vs traditional Wells score diagnostic performance.</measure>
    <time_frame>2 weeks after the end of recruitment</time_frame>
    <description>The diagnostic performance of traditional and US Wells scores will be assessed by calculating sensitivity, specificity, positive predictive value, negative predictive value, and likelihood ratios.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Failure rate and efficiency of traditional and US Wells</measure>
    <time_frame>2 weeks after the end of recruitment</time_frame>
    <description>Failure rate and efficacy of d-dimer in patients stratified as &quot;PE likely&quot; and &quot;PE unlikely&quot; will also be calculated. Failure rate (false negative proportion) will be calculated as the number of patients with negative d-dimer and confirmed PE diagnosis, divided for all patients with negative d-dimer in the same risk group. The efficiency will be calculated as the number of patients with negative d-dimer in one risk group divided for all patients included in the study.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">444</enrollment>
  <condition>Pulmonary Embolism</condition>
  <arm_group>
    <arm_group_label>Suspected pulmonary embolism patients</arm_group_label>
    <description>Adult patients (more than 18 years old) suspected of PE will be recruited at the time of the medical evaluation and before a final diagnosis is established</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients (more than 18 years old) suspected of PE presenting to ED will be recruited&#xD;
        at the time of the medical evaluation and before a final diagnosis is established.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients more than 18 years old&#xD;
&#xD;
          -  Patients presenting with dyspnea, thoracic pain or syncope, palpitations, cardiac&#xD;
             arrest&#xD;
&#xD;
          -  Suspicion of PE&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient did not consent to participate in the study&#xD;
&#xD;
          -  Presence of a diagnosis alternative to PE objectively demonstrated after the first&#xD;
             assessment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peiman Nazerian, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda Ospedaliera Universitaria Careggi, Firenze, Italia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Careggi</name>
      <address>
        <city>Firenze</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Paolo, Università degli studi di Milano</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Internal Medicine, Università degli studi di Perugia</name>
      <address>
        <city>Perugia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria San Luigi Gonzaga</name>
      <address>
        <city>Torino</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <removed_countries>
    <country>Austria</country>
  </removed_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>July 12, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>February 6, 2016</last_update_submitted>
  <last_update_submitted_qc>February 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 9, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Ospedaliero-Universitaria Careggi</investigator_affiliation>
    <investigator_full_name>Peiman Nazerian</investigator_full_name>
    <investigator_title>Medical Doctor Emergency Medicine</investigator_title>
  </responsible_party>
  <keyword>Pulmonary embolism</keyword>
  <keyword>diagnosis</keyword>
  <keyword>emergency medicine</keyword>
  <keyword>ultrasonography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Embolism</mesh_term>
    <mesh_term>Embolism</mesh_term>
  </condition_browse>
  <!-- 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/NCT02190110
org study id: 1001
nct id: NCT02190110
lead sponsor: 
has dmc: No
Pulmonary embolism (PE) should be suspected in patients with dyspnea, chest pain, syncope,
      shock/hypotension, or cardiac arrest. Discriminating patients in different categories of
      pre-test probability of PE has become a key step in all diagnostic algorithms for PE. The
      most frequently used clinical prediction rule is the Wells score ("PE likely" > 4 points and
      "PE unlikely" ≤ 4 points). PE can be safely ruled out in patients with a "PE unlikely"
      associated with a negative d-dimer test result. Conversely, patients with "PE likely" or
      positive d-dimer level should undergo further diagnostic testing, like multidetector computed
      tomography pulmonary angiography (MCTPA).

      Wells score accuracy is not optimal. Vein and lung US can be rapidly performed at bedside as
      an extension of physical examination and have a high specificity. The aim of this study is to
      evaluate if the combination of clinical data reported in the Wells score and US data obtained
      from vein and lung US (US Wells score) has a better diagnostic accuracy compared to
      traditional Wells score.

      In adult patients suspected of PE traditional Wells score will be calculated and vein and
      lung US (multiorgan US) will be performed in all patients and and US Wells score calculated.
      The US Wells score differs from the traditional Wells score in the following items: "signs
      and symptoms of DVT", replaced by "vein US showing DVT", and "alternative diagnosis less
      likely than PE" replaced by "alternative diagnosis less likely than PE after multiorgan US".
      This latter item is considered positive if at least one subpleural infarct is detected at
      lung US, and negative if no subpleural infarcts are detected and an alternative diagnosis
      like pneumonia, pleural effusion or diffuse interstitial syndrome may explain the symptoms of
      presentation. If no findings are detected at lung US, the points for the item remain the same
      assigned by traditional Wells score. Final diagnosis of PE will be preferentially established
      by MCTPA and in patients discharged without a second level imaging test because of negative
      Wells or d-dimer, and patients with not conclusive second level diagnostic test, will enter
      the 3 months follow-up protocol.

      The diagnostic performance of traditional and US Wells scores will be assessed by calculating
      sensitivity, specificity, positive, and negative predictive value, and likelihood ratios.
      Failure rate and efficacy of d-dimer in patients stratified as "PE likely" and "PE unlikely"
      will also be calculated.
observational model: Cohort
time perspective: Prospective
measure: ultrasound Wells score vs traditional Wells score diagnostic performance.
time frame: 2 weeks after the end of recruitment
description: The diagnostic performance of traditional and US Wells scores will be assessed by calculating sensitivity, specificity, positive predictive value, negative predictive value, and likelihood ratios.
measure: Failure rate and efficiency of traditional and US Wells
time frame: 2 weeks after the end of recruitment
description: Failure rate and efficacy of d-dimer in patients stratified as "PE likely" and "PE unlikely" will also be calculated. Failure rate (false negative proportion) will be calculated as the number of patients with negative d-dimer and confirmed PE diagnosis, divided for all patients with negative d-dimer in the same risk group. The efficiency will be calculated as the number of patients with negative d-dimer in one risk group divided for all patients included in the study.
arm group label: Suspected pulmonary embolism patients
description: Adult patients (more than 18 years old) suspected of PE will be recruited at the time of the medical evaluation and before a final diagnosis is established
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Peiman Nazerian, MD
role: Principal Investigator
affiliation: Azienda Ospedaliera Universitaria Careggi, Firenze, Italia
facility: 
facility: 
facility: 
facility: 
country: Italy
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Azienda Ospedaliero-Universitaria Careggi
investigator full name: Peiman Nazerian
investigator title: Medical Doctor Emergency Medicine
mesh term: Pulmonary Embolism
mesh term: Embolism