xml: <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/NCT06024863</url>
    </required_header>
    <id_info>
      <org_study_id>IRBN372016/CHUSTE</org_study_id>
      <nct_id>NCT06024863</nct_id>
    </id_info>
    <brief_title>Optimising Screening of Intermediate to High-risk Asymptomatic Sportsmen With Exercise Electrocardiogram</brief_title>
    <acronym>SEEPRED</acronym>
    <official_title>Optimising Screening of Intermediate to High-risk Asymptomatic Sportsmen With Exercise Electrocardiogram. The SEEPRED Study.</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>
        The importance of exercise electrocardiogram (ECG) is still controversial in the prevention&#xD;
        of cardiac events among sportsmen. The aim of this study was to assess the relevance of&#xD;
        exercise electrocardiogram (ECG) as a significant prognostic marker for cardiovascular events&#xD;
        when any cardiovascular disease (CVD) risk factors are present.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The SEEPRED (Sport, Exercise ECG, prediction) prospective cohort study included leisure time&#xD;
        sportsmen over 35 years old who performed exercise electrocardiogram (ECG) screening in the&#xD;
        Sports Medicine Unit of the University Hospital of Saint-Etienne from September 2011 to April&#xD;
        2016. Personal, familial history and physical examination were systematically performed&#xD;
        before maximal exercise electrocardiogram (ECG). Cardiovascular events and changes in&#xD;
        physical activity were searched after exercise electrocardiogram (ECG).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2011</start_date>
    <completion_date type="Actual">January 1, 2019</completion_date>
    <primary_completion_date type="Actual">January 1, 2014</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>Silent Myocardial ischemia (SMI)</measure>
      <time_frame>Day 1</time_frame>
      <description>Determine the frequency of exercise-induced silent myocardial ischemia (SMI).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Gender record</measure>
      <time_frame>Day 1</time_frame>
      <description>Gender will be recording during medical consultation in order to predict positive exercise ECG</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Age record</measure>
      <time_frame>Day 1</time_frame>
      <description>Age will be recording during medical consultation in order to predict positive exercise ECG</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical activity levels record</measure>
      <time_frame>Day 1</time_frame>
      <description>Physical activity levels will be recording during medical consultation in order to predict positive exercise ECG</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment record</measure>
      <time_frame>Day 1</time_frame>
      <description>Treatment will be recording during medical consultation in order to predict positive exercise ECG</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cardiovascular disease (CVD) risk factors record</measure>
      <time_frame>Day 1</time_frame>
      <description>Cardiovascular disease (CVD) risk factors will be recording during medical consultation in order to predict positive exercise ECG</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body mass index record</measure>
      <time_frame>Day 1</time_frame>
      <description>Body mass index will be recording during medical consultation in order to predict positive exercise ECG</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Score&gt;5% record</measure>
      <time_frame>Day 1</time_frame>
      <description>SCORE &gt;5% will be recording during medical consultation in order to predict positive exercise ECG</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maximal heart record</measure>
      <time_frame>Day 1</time_frame>
      <description>Maximal heart rate will be recording during medical consultation in order to predict positive exercise ECG</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maximal aerobic power record</measure>
      <time_frame>Day 1</time_frame>
      <description>Maximal aerobic power will be recording during medical consultation in order to predict positive exercise ECG</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maximal blood lactate level record</measure>
      <time_frame>Day 1</time_frame>
      <description>Maximal blood lactate level will be collected in order to predict positive exercise ECG</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Suspected SMI</measure>
      <time_frame>Day 1</time_frame>
      <description>Exercise ECG screening test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Confirmed SMI</measure>
      <time_frame>Day 1</time_frame>
      <description>Exercise ECG screening test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cardiovascular events</measure>
      <time_frame>Day 1</time_frame>
      <description>Exercise ECG screening test</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">1500</enrollment>
    <condition>Electrocardiography</condition>
    <arm_group>
      <arm_group_label>Sportsmen</arm_group_label>
      <description>Sportsmen (at least 1 hour of physical activity per week) over 35 years of age, referred by their doctor for a screening stress test on a bicycle ergometer in the sports medicine unit from September 2011 to August 2014</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Screening stress test on a bicycle ergometer (usual practise)</intervention_name>
      <arm_group_label>Sportsmen</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Leisure tim sportmen over 35 years.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
            -  Patients referred as asymptomatic by their general practitioner for an exercise&#xD;
               electrocardiogram (ECG) screening test carried out as a standard procedure for&#xD;
               resuming physical activity&#xD;
  &#xD;
            -  Patients referred as a systematic pre-participation screening to be declared an&#xD;
               athlete.&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            -  Patients with coronary artery disease (CAD) and&#xD;
  &#xD;
            -  Patients with uninterpretable ST segment due to bundle branch block&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>35 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>DAVID HUPIN, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>CHU ST ETIENNE</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Centre Hospitalier de Saint-Etienne</name>
        <address>
          <city>Saint-Étienne</city>
          <zip>42055</zip>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>March 2022</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>prediction</keyword>
    <keyword>sport</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06024863
  org study id: IRBN372016/CHUSTE
  nct id: NCT06024863
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The importance of exercise electrocardiogram (ECG) is still controversial in the prevention
        of cardiac events among sportsmen. The aim of this study was to assess the relevance of
        exercise electrocardiogram (ECG) as a significant prognostic marker for cardiovascular events
        when any cardiovascular disease (CVD) risk factors are present.
  The SEEPRED (Sport, Exercise ECG, prediction) prospective cohort study included leisure time
        sportsmen over 35 years old who performed exercise electrocardiogram (ECG) screening in the
        Sports Medicine Unit of the University Hospital of Saint-Etienne from September 2011 to April
        2016. Personal, familial history and physical examination were systematically performed
        before maximal exercise electrocardiogram (ECG). Cardiovascular events and changes in
        physical activity were searched after exercise electrocardiogram (ECG).
  observational model: Cohort
  time perspective: Prospective
  measure: Silent Myocardial ischemia (SMI)
  time frame: Day 1
  description: Determine the frequency of exercise-induced silent myocardial ischemia (SMI).
  measure: Gender record
  time frame: Day 1
  description: Gender will be recording during medical consultation in order to predict positive exercise ECG
  measure: Age record
  time frame: Day 1
  description: Age will be recording during medical consultation in order to predict positive exercise ECG
  measure: Physical activity levels record
  time frame: Day 1
  description: Physical activity levels will be recording during medical consultation in order to predict positive exercise ECG
  measure: Treatment record
  time frame: Day 1
  description: Treatment will be recording during medical consultation in order to predict positive exercise ECG
  measure: Cardiovascular disease (CVD) risk factors record
  time frame: Day 1
  description: Cardiovascular disease (CVD) risk factors will be recording during medical consultation in order to predict positive exercise ECG
  measure: Body mass index record
  time frame: Day 1
  description: Body mass index will be recording during medical consultation in order to predict positive exercise ECG
  measure: Score>5% record
  time frame: Day 1
  description: SCORE >5% will be recording during medical consultation in order to predict positive exercise ECG
  measure: Maximal heart record
  time frame: Day 1
  description: Maximal heart rate will be recording during medical consultation in order to predict positive exercise ECG
  measure: Maximal aerobic power record
  time frame: Day 1
  description: Maximal aerobic power will be recording during medical consultation in order to predict positive exercise ECG
  measure: Maximal blood lactate level record
  time frame: Day 1
  description: Maximal blood lactate level will be collected in order to predict positive exercise ECG
  measure: Suspected SMI
  time frame: Day 1
  description: Exercise ECG screening test
  measure: Confirmed SMI
  time frame: Day 1
  description: Exercise ECG screening test
  measure: Cardiovascular events
  time frame: Day 1
  description: Exercise ECG screening test
  arm group label: Sportsmen
  description: Sportsmen (at least 1 hour of physical activity per week) over 35 years of age, referred by their doctor for a screening stress test on a bicycle ergometer in the sports medicine unit from September 2011 to August 2014
  intervention type: Diagnostic Test
  intervention name: Screening stress test on a bicycle ergometer (usual practise)
  arm group label: Sportsmen
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Male
  minimum age: 35 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: DAVID HUPIN, MD
  role: Principal Investigator
  affiliation: CHU ST ETIENNE
  facility: 
  country: France
  responsible party type: Sponsor
  sharing ipd: No