<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/NCT01721369</url>
  </required_header>
  <id_info>
    <org_study_id>SYNCAT</org_study_id>
    <nct_id>NCT01721369</nct_id>
  </id_info>
  <brief_title>Applicability of Syncope Guidelines in Cataluña</brief_title>
  <acronym>SYNCAT</acronym>
  <official_title>Observational Study of the Application of the ESC2009 Syncope Guidelines in Cataluña</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic Bakken Research Center</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic Bakken Research Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of SYNCAT study is to study the level of adherence of the centers in Cataluña tu the&#xD;
      Syncope Guidelines ESC2009 for the diagnosis and treatment of syncope and the impact that&#xD;
      following them can have in the prognosis of these patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of SYNCAT study is to analyze the level of adherence of Syncope Guidelines ESC2009&#xD;
      for the management, diagnosis and treatment of syncope in a specific territory with similar&#xD;
      health structure, the region of Cataluña in Spain that includes aprox. 7,000,000 inhabitants,&#xD;
      including different complexity level of hospitals and the impact that following guidelines&#xD;
      can have in the prognosis of these patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2011</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</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>Number of Patients That Adhere to the 2009 Syncope Guidelines (ESC2009)</measure>
    <time_frame>12 months</time_frame>
    <description>To analyze the number of patients that an etiologic diagnose was established according to the New Syncope Guidelines ESC2009 in the hospital care, in a particular community with hospitals with different levels of care in a specific region of Spain.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">581</enrollment>
  <condition>Brief Loss of Consciousness</condition>
  <arm_group>
    <arm_group_label>Transient Loss of Consciousness (T-LOC)</arm_group_label>
    <description>Transient Loss of Consciousness (T-LOC). Treatment according to normal clinical practice.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Transient Loss of Consciousness (T-LOC)</intervention_name>
    <arm_group_label>Transient Loss of Consciousness (T-LOC)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Transient Loss of Conscience: T-LOC&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Each patient that comes from the Emergency room and/or in office doctors visit&#xD;
             (Internal Medicine, Cardiology, Neurology...) with Transient Loss of Conscience&#xD;
             (T-LOC)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients younger than 15 years old&#xD;
&#xD;
          -  Pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Angel Moya, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Vall d'Hebron</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jordi Tomàs, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>H. Arnau de Vilanova de Lleida</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Joan Nicolàs, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Parc Sanitari Sant Joan de Déu</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jordi Mercè, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>H. Joan XXIII</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Francesc Planas, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>H. Municipal de Badalona</affiliation>
  </overall_official>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>June 19, 2012</study_first_submitted>
  <study_first_submitted_qc>November 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 4, 2012</study_first_posted>
  <results_first_submitted>January 29, 2018</results_first_submitted>
  <results_first_submitted_qc>September 21, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">September 22, 2020</results_first_posted>
  <last_update_submitted>September 21, 2020</last_update_submitted>
  <last_update_submitted_qc>September 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>TLOC</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syncope</mesh_term>
    <mesh_term>Unconsciousness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Transient Loss of Consciousness (T-LOC)</title>
          <description>Patient with transient loss of consciousness (T-LOC)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="581"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="569"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Not initial etiological diagnosis</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Patients with transient loss of consciousness (T-LOC) from the emergency service and/or external clinic visits (Cardiology, Neurology, etc).</population>
      <group_list>
        <group group_id="B1">
          <title>Transient Loss of Consciousness (T-LOC)</title>
          <description>Patients with transient loss of consciousness (T-LOC)</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="581"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="214"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="358"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="253"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="328"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="581"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Patients That Adhere to the 2009 Syncope Guidelines (ESC2009)</title>
        <description>To analyze the number of patients that an etiologic diagnose was established according to the New Syncope Guidelines ESC2009 in the hospital care, in a particular community with hospitals with different levels of care in a specific region of Spain.</description>
        <time_frame>12 months</time_frame>
        <population>Patients with transient loss of consciousness (T-LOC) from the emergency service and/or external clinic visits (Cardiology, Neurology, etc)</population>
        <group_list>
          <group group_id="O1">
            <title>Transient Loss of Consciousness (T-LOC)</title>
            <description>Patients with transient loss of consciousness (T-LOC)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients That Adhere to the 2009 Syncope Guidelines (ESC2009)</title>
          <description>To analyze the number of patients that an etiologic diagnose was established according to the New Syncope Guidelines ESC2009 in the hospital care, in a particular community with hospitals with different levels of care in a specific region of Spain.</description>
          <population>Patients with transient loss of consciousness (T-LOC) from the emergency service and/or external clinic visits (Cardiology, Neurology, etc)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="569"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="233"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <desc>Serious adverse events (SAE) were recollect at 1 year follow up, other adverse events were not recollected in this observational study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Transient Loss of Consciousness (T-LOC)</title>
          <description>Patient with transient loss of consciousness (T-LOC)</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="163" subjects_at_risk="569"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Life-threatening illness or injury</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="569"/>
              </event>
              <event>
                <sub_title>Hospitalization</sub_title>
                <counts group_id="E1" subjects_affected="123" subjects_at_risk="569"/>
              </event>
              <event>
                <sub_title>Permanent insufficiency of a body structure or a body function</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="569"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="35" subjects_at_risk="569"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Observational study</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Angel Moya</name_or_title>
      <organization>Hospital Vall hebron</organization>
      <email>amoyamitjans@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01721369
org study id: SYNCAT
nct id: NCT01721369
lead sponsor: 
has dmc: No
The aim of SYNCAT study is to study the level of adherence of the centers in Cataluña tu the
      Syncope Guidelines ESC2009 for the diagnosis and treatment of syncope and the impact that
      following them can have in the prognosis of these patients.
The aim of SYNCAT study is to analyze the level of adherence of Syncope Guidelines ESC2009
      for the management, diagnosis and treatment of syncope in a specific territory with similar
      health structure, the region of Cataluña in Spain that includes aprox. 7,000,000 inhabitants,
      including different complexity level of hospitals and the impact that following guidelines
      can have in the prognosis of these patients.
observational model: Cohort
time perspective: Prospective
measure: Number of Patients That Adhere to the 2009 Syncope Guidelines (ESC2009)
time frame: 12 months
description: To analyze the number of patients that an etiologic diagnose was established according to the New Syncope Guidelines ESC2009 in the hospital care, in a particular community with hospitals with different levels of care in a specific region of Spain.
arm group label: Transient Loss of Consciousness (T-LOC)
description: Transient Loss of Consciousness (T-LOC). Treatment according to normal clinical practice.
intervention type: Diagnostic Test
intervention name: Transient Loss of Consciousness (T-LOC)
arm group label: Transient Loss of Consciousness (T-LOC)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
healthy volunteers: No
last name: Angel Moya, Dr.
role: Principal Investigator
affiliation: Hospital Vall d'Hebron
last name: Jordi Tomàs, Dr.
role: Principal Investigator
affiliation: H. Arnau de Vilanova de Lleida
last name: Joan Nicolàs, Dr.
role: Principal Investigator
affiliation: Parc Sanitari Sant Joan de Déu
last name: Jordi Mercè, Dr.
role: Principal Investigator
affiliation: H. Joan XXIII
last name: Francesc Planas, Dr.
role: Principal Investigator
affiliation: H. Municipal de Badalona
responsible party type: Sponsor
mesh term: Syncope
mesh term: Unconsciousness
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Observational study
point of contact: 