<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/NCT04413825</url>
  </required_header>
  <id_info>
    <org_study_id>Gazi U.</org_study_id>
    <nct_id>NCT04413825</nct_id>
  </id_info>
  <brief_title>Early Systolic Notching in Pulmonary Embolism</brief_title>
  <official_title>Diagnostic Accuracy of Early Systolic Notching in Pulmonary Embolism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gazi University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Akdeniz University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ege University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Antalya Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rize Üniversitesi</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Izmir Katip Celebi University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Gazi 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>
      Venous thromboembolism (VTE), clinically seen as deep vein thrombosis (DVT) or pulmonary&#xD;
      embolism (PE), is the third most common acute cardiovascular syndrome after myocardial&#xD;
      infarction and stroke. In a study conducted by critical care and emergency physicians, lung&#xD;
      ultrasonography (US) for pleural infarction areas, lower extremity venous US in terms of DVT,&#xD;
      and focused cardiac US in terms of right ventricular strain were demonstrated with different&#xD;
      diagnostic values for PE. However, no ultrasonographic method alone has a high diagnostic&#xD;
      value for PE alone in the literature. In a recent study, it is stated that a new cardiac&#xD;
      finding (early systolic notch- ESN) has high sensitivity (92%) and specificity (99%) in&#xD;
      massive and submassive emboli. However, the limited patient population and the exclusion of&#xD;
      many patient groups limits the applicability of the study and its use in other patient&#xD;
      groups. With this study, it was aimed to determine the diagnostic value of ESN finding within&#xD;
      the emergency department conditions by keeping the patient population wider.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2020</start_date>
  <completion_date type="Actual">January 15, 2021</completion_date>
  <primary_completion_date type="Actual">January 15, 2021</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>To determine the diagnostic accuracy of the ESN finding</measure>
    <time_frame>6 months</time_frame>
    <description>What is the diagnostic value of ESN finding in patients with PE diagnosed with pulmonary CT angio?</description>
  </primary_outcome>
  <enrollment type="Actual">180</enrollment>
  <condition>Pulmonary Embolism</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who presented to the emergency department and underwent pulmonary CT angio imaging&#xD;
        with suspicion of pulmonary embolism.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing pulmonary CT angiography with suspicion of pulmonary embolism&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women,&#xD;
&#xD;
          -  Patients under 18 years of age,&#xD;
&#xD;
          -  Those who received thrombolytic therapy,&#xD;
&#xD;
          -  Poor ultrasound imaging.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Gazi University Facaulty of Medicine</name>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>February 1, 2021</last_update_submitted>
  <last_update_submitted_qc>February 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gazi University</investigator_affiliation>
    <investigator_full_name>Mehmet Ali Aslaner</investigator_full_name>
    <investigator_title>Assos. Prof.</investigator_title>
  </responsible_party>
  <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>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT04413825
org study id: Gazi U.
nct id: NCT04413825
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Venous thromboembolism (VTE), clinically seen as deep vein thrombosis (DVT) or pulmonary
      embolism (PE), is the third most common acute cardiovascular syndrome after myocardial
      infarction and stroke. In a study conducted by critical care and emergency physicians, lung
      ultrasonography (US) for pleural infarction areas, lower extremity venous US in terms of DVT,
      and focused cardiac US in terms of right ventricular strain were demonstrated with different
      diagnostic values for PE. However, no ultrasonographic method alone has a high diagnostic
      value for PE alone in the literature. In a recent study, it is stated that a new cardiac
      finding (early systolic notch- ESN) has high sensitivity (92%) and specificity (99%) in
      massive and submassive emboli. However, the limited patient population and the exclusion of
      many patient groups limits the applicability of the study and its use in other patient
      groups. With this study, it was aimed to determine the diagnostic value of ESN finding within
      the emergency department conditions by keeping the patient population wider.
observational model: Cohort
time perspective: Prospective
measure: To determine the diagnostic accuracy of the ESN finding
time frame: 6 months
description: What is the diagnostic value of ESN finding in patients with PE diagnosed with pulmonary CT angio?
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Gazi University
investigator full name: Mehmet Ali Aslaner
investigator title: Assos. Prof.
mesh term: Pulmonary Embolism
mesh term: Embolism
sharing ipd: Undecided