<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/NCT04454554</url>
  </required_header>
  <id_info>
    <org_study_id>FAA O4 5-2018 (PEDIS)</org_study_id>
    <nct_id>NCT04454554</nct_id>
  </id_info>
  <brief_title>Prevalence of Pulmonary Embolism in Patients With Dyspnea on Exertion (PEDIS)</brief_title>
  <acronym>PEDIS</acronym>
  <official_title>Prevalence of Pulmonary Embolism (PE) Among Patients Referred to Emergency Departments for Dyspnea on Exertion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Arianna Anticoagulazione Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Arianna Anticoagulazione Foundation</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>
      PEDIS Study is an observational, cross-sectional, multicenter Italian study conducted in a&#xD;
      consecutive series of patients who refer to the Emergency Departments (either spontaneously&#xD;
      or sent by their attending physicians) for the recent (less than one months) development of&#xD;
      exertional dyspnea.&#xD;
&#xD;
      The general aim of the study is to assess the prevalence of PE in the overall population&#xD;
      referring to the Emergency Departments without potential explanations for dyspnea&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PEDIS Study is an observational, cross-sectional, multicenter and no Profit Study.&#xD;
&#xD;
      600 consecutive patients referring to the Emergency Departments of the participating centers&#xD;
      because they have developed one or more episodes of exertional dyspnea since less than one&#xD;
      month will be enrolled. All eligible patients will be interviewed and examined by trained&#xD;
      study physicians. The presence of already known potential explanations for the dyspnea will&#xD;
      be assessed. In addition, symptoms of the lower extremities will be elicited, as well as the&#xD;
      presence of risk factors for venous thromboembolism (VTE).&#xD;
&#xD;
      The presence or absence of pulmonary embolism will be assessed with the use of a validated&#xD;
      algorithm based on pre-test clinical probability and D-dimer result. In patients in whom the&#xD;
      pre-test clinical probability is low and the D-dimer result is negative, no further testing&#xD;
      will be done, and PE will be considered excluded. In patients with high clinical probability,&#xD;
      positive D-dimer result, or both, computed tomography (CT) pulmonary angiography will be&#xD;
      performed&#xD;
&#xD;
      The primary study objective is to evaluate Prevalence of PE in the overall population&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 24, 2018</start_date>
  <completion_date type="Actual">January 30, 2021</completion_date>
  <primary_completion_date type="Actual">December 24, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of PE in the overall population</measure>
    <time_frame>From the first day of enrollment up to 104 weeks</time_frame>
    <description>Prevalence of Pulmonary Embolism in patient with high pre-test clinical probability and/or positive D-dimer without potential explanations for the dyspnea who underwent computed tomography pulmonary angiography</description>
  </primary_outcome>
  <enrollment type="Actual">400</enrollment>
  <condition>Pulmonary Embolism</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All consecutive patients who refer to the Emergency Departments of the participating&#xD;
        centers will be eligible for the study provided they are older than 18 and younger than 75&#xD;
        years, and have developed one or more episodes of exertional dyspnea since less than one&#xD;
        month.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age older than 18 and younger than 75&#xD;
&#xD;
          -  Recent (less than one month) development of exertional dyspnea&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anticoagulation required for other indications&#xD;
&#xD;
          -  Contraindication to CT angiography (allergy to the contrast dye, severe renal failure&#xD;
             [creatinine clearance &lt; 30 ml/min])&#xD;
&#xD;
          -  Involvement in simultaneous clinical trials&#xD;
&#xD;
          -  Unable to provide their written informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carlo Bova, MD</last_name>
    <role>Study Director</role>
    <affiliation>Azienda Ospedaliera di Cosenza</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Azienda Ospedalier di Cosenza &quot;SS.Annunziata&quot;</name>
      <address>
        <city>Cosenza</city>
        <zip>87100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>March 18, 2021</last_update_submitted>
  <last_update_submitted_qc>March 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dyspnea</keyword>
  <keyword>Pulmonary embolism</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Embolism</mesh_term>
    <mesh_term>Dyspnea</mesh_term>
    <mesh_term>Embolism</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 16, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/54/NCT04454554/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04454554
org study id: FAA O4 5-2018 (PEDIS)
nct id: NCT04454554
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
PEDIS Study is an observational, cross-sectional, multicenter Italian study conducted in a
      consecutive series of patients who refer to the Emergency Departments (either spontaneously
      or sent by their attending physicians) for the recent (less than one months) development of
      exertional dyspnea.

      The general aim of the study is to assess the prevalence of PE in the overall population
      referring to the Emergency Departments without potential explanations for dyspnea
PEDIS Study is an observational, cross-sectional, multicenter and no Profit Study.

      600 consecutive patients referring to the Emergency Departments of the participating centers
      because they have developed one or more episodes of exertional dyspnea since less than one
      month will be enrolled. All eligible patients will be interviewed and examined by trained
      study physicians. The presence of already known potential explanations for the dyspnea will
      be assessed. In addition, symptoms of the lower extremities will be elicited, as well as the
      presence of risk factors for venous thromboembolism (VTE).

      The presence or absence of pulmonary embolism will be assessed with the use of a validated
      algorithm based on pre-test clinical probability and D-dimer result. In patients in whom the
      pre-test clinical probability is low and the D-dimer result is negative, no further testing
      will be done, and PE will be considered excluded. In patients with high clinical probability,
      positive D-dimer result, or both, computed tomography (CT) pulmonary angiography will be
      performed

      The primary study objective is to evaluate Prevalence of PE in the overall population
observational model: Other
time perspective: Cross-Sectional
measure: Prevalence of PE in the overall population
time frame: From the first day of enrollment up to 104 weeks
description: Prevalence of Pulmonary Embolism in patient with high pre-test clinical probability and/or positive D-dimer without potential explanations for the dyspnea who underwent computed tomography pulmonary angiography
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Carlo Bova, MD
role: Study Director
affiliation: Azienda Ospedaliera di Cosenza
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Pulmonary Embolism
mesh term: Dyspnea
mesh term: Embolism
provided document: 