<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/NCT03034525</url>
  </required_header>
  <id_info>
    <org_study_id>551-16-CTIL</org_study_id>
    <nct_id>NCT03034525</nct_id>
  </id_info>
  <brief_title>Assessing the Risk of Pulmonary Embolism in Patients After Hospitalization for First Episode of Syncope</brief_title>
  <official_title>Assessing the Risk of Pulmonary Embolism in Patients After Hospitalization for First Episode of Syncope</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rambam Health Care Campus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rambam Health Care Campus</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>
      Acute pulmonary embolism (APE) is a common disease, which involves significant morbidity and&#xD;
      mortality. The clinical presentation of APE has many faces but it is acceptable to suspect&#xD;
      this disease when the patient presenting with at least one of the following: shortness of&#xD;
      breath, pleuritic chest pain, cough, sub-febrile fever or hemoptysis.&#xD;
&#xD;
      The relationship between syncope and APE is not entirely clear. Prandoni et al conducted a&#xD;
      systematic process for the exclusion / confirmation of APE all patients hospitalized for a&#xD;
      first investigation of syncope. In this study APE was diagnosed in about 17% of the patients.&#xD;
      In 12.7% of patients with an alternative explanation for syncope APE was diagnosed.&#xD;
      Interestingly, 25% of the patients had no other manifestation of pulmonary embolism apart&#xD;
      from the syncope itself.&#xD;
&#xD;
      According to the updated clinical guidelines, APE should not be routinely tested as an&#xD;
      etiology for syncope and not systematically excluded. According to the new data presented by&#xD;
      Prandoni et al, this means that a significant percentage of patients hospitalized for an&#xD;
      investigation of syncope are discharged when they are suffering from APE (in most cases&#xD;
      probably an event of unprovoked pulmonary embolism) without treatment with anticoagulants,&#xD;
      making them particularly prone to PE recurrence.&#xD;
&#xD;
      Aim. To examine the incidence of pulmonary embolism (Pulmonary Embolism, PE), and VTE (venous&#xD;
      thromboembolism, VTE) in patients hospitalized for a first investigation of syncope.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Method.&#xD;
&#xD;
      Study population:&#xD;
&#xD;
      The study is a retrospective, multicenter cohort study, conducted at Rambam Health Care&#xD;
      Campus and Sourasky Medical Center, Tel Aviv and includes all Clalit HMO insured patients who&#xD;
      were admitted for investigation of first event of syncope from 2006 to 2013 (diagnosis on&#xD;
      admission- syncope and collapse (ICD9 code 427.31)).&#xD;
&#xD;
      Inclusion criteria:&#xD;
&#xD;
        -  Patients over 18 years old during study period.&#xD;
&#xD;
        -  On admission diagnosis of syncope and collapse (ICD9 code 427.31).&#xD;
&#xD;
        -  Patients are insured by Clalit Health Services.&#xD;
&#xD;
      Exclusion criteria:&#xD;
&#xD;
        -  Hospitalization during the study period for additional event of syncope.&#xD;
&#xD;
        -  Patients receiving anticoagulation on recruitment.&#xD;
&#xD;
        -  Patients investigated for APE during hospitalization (by testing for D-dimer,&#xD;
           computerized tomography angiography or perfusion-ventilation lung scan).&#xD;
&#xD;
        -  Patients who began treatment anticoagulation, not because of VTE, during study period.&#xD;
&#xD;
      Study design The research is divided into two main stages. At the first phase data of the&#xD;
      relevant study population will be collected from the computerized medical record of the two&#xD;
      medical centers mentioned above and according to the inclusion and exclusions criteria listed&#xD;
      above.&#xD;
&#xD;
      In the second phase we will examine in the study population the occurrence of PE or DVT&#xD;
      within 36 months from hospitalization.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 1, 2017</start_date>
  <completion_date type="Anticipated">February 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">February 1, 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>venous thromboembolism</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">7000</enrollment>
  <condition>Pulmonary Embolism</condition>
  <condition>Syncope</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The study is a retrospective, multicenter cohort study, conducted at Rambam Health Care&#xD;
        Campus and Sourasky Medical Center, Tel Aviv and includes all Clalit HMO insured patients&#xD;
        who were admitted for investigation of first event of syncope from 2006 to 2013 (diagnosis&#xD;
        on admission- syncope and collapse (ICD9 code 427.31)).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over 18 years old during study period.&#xD;
&#xD;
             * On admission diagnosis of syncope and collapse (ICD9 code 427.31).&#xD;
&#xD;
          -  Patients are insured by Clalit Health Services.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        * Hospitalization during the study period for additional event of syncope.&#xD;
&#xD;
          -  Patients receiving anticoagulation on recruitment.&#xD;
&#xD;
          -  Patients investigated for APE during hospitalization (by testing for D-dimer,&#xD;
             computerized tomography angiography or perfusion-ventilation lung scan).&#xD;
&#xD;
          -  Patients who began treatment anticoagulation, not because of VTE, during study period.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>January 25, 2017</last_update_submitted>
  <last_update_submitted_qc>January 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rambam Health Care Campus</investigator_affiliation>
    <investigator_full_name>rambam71</investigator_full_name>
    <investigator_title>MD</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>Syncope</mesh_term>
    <mesh_term>Embolism</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03034525
org study id: 551-16-CTIL
nct id: NCT03034525
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Acute pulmonary embolism (APE) is a common disease, which involves significant morbidity and
      mortality. The clinical presentation of APE has many faces but it is acceptable to suspect
      this disease when the patient presenting with at least one of the following: shortness of
      breath, pleuritic chest pain, cough, sub-febrile fever or hemoptysis.

      The relationship between syncope and APE is not entirely clear. Prandoni et al conducted a
      systematic process for the exclusion / confirmation of APE all patients hospitalized for a
      first investigation of syncope. In this study APE was diagnosed in about 17% of the patients.
      In 12.7% of patients with an alternative explanation for syncope APE was diagnosed.
      Interestingly, 25% of the patients had no other manifestation of pulmonary embolism apart
      from the syncope itself.

      According to the updated clinical guidelines, APE should not be routinely tested as an
      etiology for syncope and not systematically excluded. According to the new data presented by
      Prandoni et al, this means that a significant percentage of patients hospitalized for an
      investigation of syncope are discharged when they are suffering from APE (in most cases
      probably an event of unprovoked pulmonary embolism) without treatment with anticoagulants,
      making them particularly prone to PE recurrence.

      Aim. To examine the incidence of pulmonary embolism (Pulmonary Embolism, PE), and VTE (venous
      thromboembolism, VTE) in patients hospitalized for a first investigation of syncope.
Method.

      Study population:

      The study is a retrospective, multicenter cohort study, conducted at Rambam Health Care
      Campus and Sourasky Medical Center, Tel Aviv and includes all Clalit HMO insured patients who
      were admitted for investigation of first event of syncope from 2006 to 2013 (diagnosis on
      admission- syncope and collapse (ICD9 code 427.31)).

      Inclusion criteria:

        -  Patients over 18 years old during study period.

        -  On admission diagnosis of syncope and collapse (ICD9 code 427.31).

        -  Patients are insured by Clalit Health Services.

      Exclusion criteria:

        -  Hospitalization during the study period for additional event of syncope.

        -  Patients receiving anticoagulation on recruitment.

        -  Patients investigated for APE during hospitalization (by testing for D-dimer,
           computerized tomography angiography or perfusion-ventilation lung scan).

        -  Patients who began treatment anticoagulation, not because of VTE, during study period.

      Study design The research is divided into two main stages. At the first phase data of the
      relevant study population will be collected from the computerized medical record of the two
      medical centers mentioned above and according to the inclusion and exclusions criteria listed
      above.

      In the second phase we will examine in the study population the occurrence of PE or DVT
      within 36 months from hospitalization.
observational model: Cohort
time perspective: Retrospective
measure: venous thromboembolism
time frame: 3 years
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Rambam Health Care Campus
investigator full name: rambam71
investigator title: MD
mesh term: Pulmonary Embolism
mesh term: Syncope
mesh term: Embolism
sharing ipd: No