<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/NCT04483843</url>
  </required_header>
  <id_info>
    <org_study_id>2019-03</org_study_id>
    <nct_id>NCT04483843</nct_id>
  </id_info>
  <brief_title>Cosmic Weather and Cardiogenic Pulmonary Edema</brief_title>
  <official_title>Impact of Cosmic Weather on Pre-hospital Incidence of Cardiogenic Pulmonary Edema</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emergency Medical Service of the Central Bohemian Region, Czech Republic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Masaryk Hospital Usti nad Labem</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institute of Experimental Physics, Slovak Academy of Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Emergency Medical Service of the Central Bohemian Region, Czech Republic</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>
      Retrospective clinical study to evaluate whether there is any correlation between the&#xD;
      pre-hospital incidence of cardiogenic pulmonary oedema (CPE) in the selected region and the&#xD;
      space weather parameters.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Emergency Medical Service of the Central Bohemian Region is the exclusive provider of primary&#xD;
      pre-hospital emergency care in the Central Bohemian Region, Czech Republic. The region&#xD;
      includes both the rural and urban population, in total of 1 315 299 inhabitants on a total&#xD;
      area of 11 015 km2. A computer search of patients with dyspnoea between 1.10.2008 and&#xD;
      30.6.2014 will be conducted and all cases of cardiogenic pulmonary oedema will be selected.&#xD;
&#xD;
      Physical parameters of space weather and geomagnetic field disturbances will be obtained from&#xD;
      the database of Institute of Experimental Physics, Slovak Academy of Sciences, Slovak&#xD;
      Republic. The datasets will be analysed whether there is any correlation between the&#xD;
      pre-hospital incidence of CPE in the selected region and the parameters of space weather and&#xD;
      geomagnetic field disturbances.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">August 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Significant correlation between incidence of CPE and activity of the space weather</measure>
    <time_frame>4 years</time_frame>
    <description>Significant correlation between incidence of CPE and activity of the space weather</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Significant correlation between incidence of CPE and the degree of the geomagnetic field disturbance</measure>
    <time_frame>4 years</time_frame>
    <description>Significant correlation between incidence of CPE and the degree of the geomagnetic field disturbance</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">4000</enrollment>
  <condition>Pulmonary Edema Cardiac Cause</condition>
  <arm_group>
    <arm_group_label>CPE patients</arm_group_label>
    <description>All patients prehospitally treated for cardiogenic pulmonary edema in the pre-hospital emergency setting in the Central Bohemian region, Czech Republic.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>No intervention will be performed while it is retrospective observational study.</description>
    <arm_group_label>CPE patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients from the registry of the Emergency Medical Service of the Central Bohemian&#xD;
        Region, Czech Republic who were treated prehospitally for cardiogenic pulmonary edema&#xD;
        between 1.10.2008 and 30.6.2014.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients treated by Emergency Medical Service of the Central Bohemian Region for&#xD;
             cardiogenic pulmonary edema between 1.10.2008 and 30.6.2014.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Dyspnea from other cause than cardiogenic pulmonary edema.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roman Skulec, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emergency Medical Service of the Central Bohemian Region, Czech Republic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emergency Medical Service of the Central Bohemian Region</name>
      <address>
        <city>Beroun</city>
        <state>Central Bohemian Region</state>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>August 3, 2019</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 26, 2020</last_update_submitted>
  <last_update_submitted_qc>July 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emergency Medical Service of the Central Bohemian Region, Czech Republic</investigator_affiliation>
    <investigator_full_name>Roman Skulec</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Edema</mesh_term>
    <mesh_term>Edema</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No sharing anticipated.</ipd_description>
  </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/NCT04483843
org study id: 2019-03
nct id: NCT04483843
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Retrospective clinical study to evaluate whether there is any correlation between the
      pre-hospital incidence of cardiogenic pulmonary oedema (CPE) in the selected region and the
      space weather parameters.
Emergency Medical Service of the Central Bohemian Region is the exclusive provider of primary
      pre-hospital emergency care in the Central Bohemian Region, Czech Republic. The region
      includes both the rural and urban population, in total of 1 315 299 inhabitants on a total
      area of 11 015 km2. A computer search of patients with dyspnoea between 1.10.2008 and
      30.6.2014 will be conducted and all cases of cardiogenic pulmonary oedema will be selected.

      Physical parameters of space weather and geomagnetic field disturbances will be obtained from
      the database of Institute of Experimental Physics, Slovak Academy of Sciences, Slovak
      Republic. The datasets will be analysed whether there is any correlation between the
      pre-hospital incidence of CPE in the selected region and the parameters of space weather and
      geomagnetic field disturbances.
observational model: Case-Only
time perspective: Retrospective
measure: Significant correlation between incidence of CPE and activity of the space weather
time frame: 4 years
description: Significant correlation between incidence of CPE and activity of the space weather
measure: Significant correlation between incidence of CPE and the degree of the geomagnetic field disturbance
time frame: 4 years
description: Significant correlation between incidence of CPE and the degree of the geomagnetic field disturbance
arm group label: CPE patients
description: All patients prehospitally treated for cardiogenic pulmonary edema in the pre-hospital emergency setting in the Central Bohemian region, Czech Republic.
intervention type: Other
intervention name: No intervention
description: No intervention will be performed while it is retrospective observational study.
arm group label: CPE patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Roman Skulec, MD, PhD
role: Principal Investigator
affiliation: Emergency Medical Service of the Central Bohemian Region, Czech Republic
facility: 
country: Czechia
responsible party type: Principal Investigator
investigator affiliation: Emergency Medical Service of the Central Bohemian Region, Czech Republic
investigator full name: Roman Skulec
investigator title: Principal investigator
mesh term: Pulmonary Edema
mesh term: Edema
sharing ipd: No
ipd description: No sharing anticipated.