<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/NCT04423822</url>
  </required_header>
  <id_info>
    <org_study_id>19CH235</org_study_id>
    <secondary_id>2020-A00270-39</secondary_id>
    <nct_id>NCT04423822</nct_id>
  </id_info>
  <brief_title>Stress Test on the Prediction of Cardiovascular Events in a High-risk Firefighter Population</brief_title>
  <acronym>FIRE-PREV</acronym>
  <official_title>Contributions and Limitations of the Stress Test on the Prediction of Cardiovascular Events in a High-risk Firefighter Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Saint Etienne</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>
      If the risk of myocardial infarction in activity is widely demonstrated to date for&#xD;
      firefighters, and the realization of a stress test in those at high cardiovascular risk&#xD;
      included in the practice habits, no study has evaluated the contributions and limits of the&#xD;
      realization of a stress test in this specific population of firefighters at high&#xD;
      cardiovascular risk for the prediction of cardiovascular events.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The professional practice of firefighting presents risks specific, especially cardiovascular.&#xD;
      In the United States 30% of Firefighter deaths are the result of a myocardial infarction that&#xD;
      occurred while on duty. Certain occupational tasks expose firefighters to a higher risk of&#xD;
      myocardial infarction (high physical load, inhalation of products). There is no&#xD;
      recommendation on how to assess cardiovascular risk in French firefighters. In the absence of&#xD;
      consensus, the Loire Departmental Fire and Rescue Service has constructed a scale for&#xD;
      collecting cardiovascular risk factors (expert working group) to identify firefighters at&#xD;
      high cardiovascular risk. A maintenance visit (mandatory every two years until the age of 38&#xD;
      and then once a year) is the best way to assess this cardiovascular risk, with a biological&#xD;
      assessment and an electrocardiogram after the age of 40. If cardiovascular risk factors are&#xD;
      present and the cardiovascular risk is high, the resting electrocardiogram should be&#xD;
      supplemented by an exercise test. An exercise test can directly or indirectly quantify the&#xD;
      endurance capacities of firefighters and reveal cardiac abnormalities sometimes absent at&#xD;
      rest. Half of all myocardial infarctions occur without any prior symptomatology and remain&#xD;
      totally asymptomatic, discovered during routine examinations. If the risk of myocardial&#xD;
      infarction in activity is widely demonstrated to date for firefighters, and the realization&#xD;
      of a stress test in those at high cardiovascular risk included in the practice habits, no&#xD;
      study has evaluated the contributions and limits of the realization of a stress test in this&#xD;
      specific population of firefighters at high cardiovascular risk for the prediction of&#xD;
      cardiovascular events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    failure to recruit&#xD;
  </why_stopped>
  <start_date type="Actual">January 12, 2021</start_date>
  <completion_date type="Actual">September 18, 2021</completion_date>
  <primary_completion_date type="Actual">September 18, 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiovascular morbidity</measure>
    <time_frame>Between 2006 and 2014</time_frame>
    <description>determined by occurrence of: Cardiovascular death; Myocardial infarction; stroke; Arteriopathy; Atrial fibrillation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cardiovascular mortality</measure>
    <time_frame>Between 2006 and 2014</time_frame>
    <description>determined by occurrence of: Cardiovascular death; Myocardial infarction; stroke; Arteriopathy; Atrial fibrillation</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">94</enrollment>
  <condition>High Cardiovascular Risk</condition>
  <condition>Firefighter</condition>
  <arm_group>
    <arm_group_label>Firefighter</arm_group_label>
    <description>Firefighter with high cardiovascular risk</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>stress test</intervention_name>
    <description>endurance capacity</description>
    <arm_group_label>Firefighter</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        firefighters with high cardiovascular risk&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any professional or volunteer firefighter with a high cardiovascular risk attached to&#xD;
             the Departmental Fire and Rescue Service of the Loire who has carried out an effort&#xD;
             test between 2006 and 2014.&#xD;
&#xD;
          -  Subject who received informed oral information about the study by telephone and agreed&#xD;
             to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject unable to understand the study&#xD;
&#xD;
          -  Subject matter subject to a legal protection measure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David HUPIN, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU SAINT-ETIENNE</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire</name>
      <address>
        <city>Saint-Étienne</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>December 21, 2021</last_update_submitted>
  <last_update_submitted_qc>December 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>firefighter</keyword>
  <keyword>high cardiovascular risk</keyword>
  <keyword>stress tests</keyword>
  <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/NCT04423822
org study id: 19CH235
secondary id: 2020-A00270-39
nct id: NCT04423822
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
If the risk of myocardial infarction in activity is widely demonstrated to date for
      firefighters, and the realization of a stress test in those at high cardiovascular risk
      included in the practice habits, no study has evaluated the contributions and limits of the
      realization of a stress test in this specific population of firefighters at high
      cardiovascular risk for the prediction of cardiovascular events.
The professional practice of firefighting presents risks specific, especially cardiovascular.
      In the United States 30% of Firefighter deaths are the result of a myocardial infarction that
      occurred while on duty. Certain occupational tasks expose firefighters to a higher risk of
      myocardial infarction (high physical load, inhalation of products). There is no
      recommendation on how to assess cardiovascular risk in French firefighters. In the absence of
      consensus, the Loire Departmental Fire and Rescue Service has constructed a scale for
      collecting cardiovascular risk factors (expert working group) to identify firefighters at
      high cardiovascular risk. A maintenance visit (mandatory every two years until the age of 38
      and then once a year) is the best way to assess this cardiovascular risk, with a biological
      assessment and an electrocardiogram after the age of 40. If cardiovascular risk factors are
      present and the cardiovascular risk is high, the resting electrocardiogram should be
      supplemented by an exercise test. An exercise test can directly or indirectly quantify the
      endurance capacities of firefighters and reveal cardiac abnormalities sometimes absent at
      rest. Half of all myocardial infarctions occur without any prior symptomatology and remain
      totally asymptomatic, discovered during routine examinations. If the risk of myocardial
      infarction in activity is widely demonstrated to date for firefighters, and the realization
      of a stress test in those at high cardiovascular risk included in the practice habits, no
      study has evaluated the contributions and limits of the realization of a stress test in this
      specific population of firefighters at high cardiovascular risk for the prediction of
      cardiovascular events.
observational model: Cohort
time perspective: Retrospective
measure: Cardiovascular morbidity
time frame: Between 2006 and 2014
description: determined by occurrence of: Cardiovascular death; Myocardial infarction; stroke; Arteriopathy; Atrial fibrillation
measure: Cardiovascular mortality
time frame: Between 2006 and 2014
description: determined by occurrence of: Cardiovascular death; Myocardial infarction; stroke; Arteriopathy; Atrial fibrillation
arm group label: Firefighter
description: Firefighter with high cardiovascular risk
intervention type: Other
intervention name: stress test
description: endurance capacity
arm group label: Firefighter
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David HUPIN, MD
role: Principal Investigator
affiliation: CHU SAINT-ETIENNE
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No