<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/NCT03780231</url>
  </required_header>
  <id_info>
    <org_study_id>35RC18_3026_EISCAR</org_study_id>
    <nct_id>NCT03780231</nct_id>
  </id_info>
  <brief_title>Effect of Intense Sport Practice in Athletes With Non-ischemic Scar</brief_title>
  <acronym>EISCAR</acronym>
  <official_title>Effect of Intense Sport Practice in Athletes With Non-ischemic Scar</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rennes University Hospital</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 prognostic relevance of isolated non-ischemic LGE (i.e. with no underlying &quot;labelled&quot;&#xD;
      cardiomyopathy) is unclear, and current guidelines to not state on the clearance of athlete&#xD;
      with this type of findings as regards to competitive or intense sport practice.&#xD;
&#xD;
      The principal objective of the study is to evaluate during a five-years follow up, the&#xD;
      clinical outcome of athletes with this kind of findings. The secondary objective is the&#xD;
      determination of prognostic factors. The management and follow-up of the athletes will be let&#xD;
      at the appraisal of each center.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The presence of a scar, assessed by late gadolinium enhancement (LGE) on cardiac resonance&#xD;
      imaging (CMR), is associated with a poor prognosis in patients with ischemic heart disease or&#xD;
      cardiomyopathy. But the prognostic relevance of isolated non-ischemic LGE (i.e. with no&#xD;
      underlying &quot;labelled&quot; cardiomyopathy) is unclear, and current guidelines do not state on the&#xD;
      clearance of athlete with this type of findings as regards to competitive or intense sport&#xD;
      practice.&#xD;
&#xD;
      The objective of the study is to evaluate the clinical outcome of athletes with isolated&#xD;
      non-ischemic LGE with no underlying &quot;labelled&quot; cardiomyopathy during a five-years follow-up.&#xD;
      The secondary objective is the determination of prognostic factors based on the baseline&#xD;
      inclusion data: indication of CMR (i.e. symptoms, abnormal ECG, presence and morphology of&#xD;
      arrhythmias, abnormal echocardiography); localization and amount of LGE, left and right&#xD;
      ventricular geometry and function, characteristics of sport practice (amount, type,&#xD;
      competition).&#xD;
&#xD;
      The management of the athletes will be let at the appraisal of each centre, as regards to the&#xD;
      initial assessment, the follow-up and the medical clearance for competitive sports&#xD;
      participation. Nevertheless, due to the absence of consensus, we propose that the patient&#xD;
      should at least undergo clinical examination, ECG, echocardiography, cardiopulmonary exercise&#xD;
      test (CPET) and holter ECG each year. A CMR should be performed at one and five years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 5, 2018</start_date>
  <completion_date type="Anticipated">October 5, 2025</completion_date>
  <primary_completion_date type="Anticipated">October 5, 2020</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>Occurrence of a major cardiac event</measure>
    <time_frame>five years after inclusion</time_frame>
    <description>During a follow-up of 5 years, occurrence of a major cardiac event defined by either: death, death of cardiovascular cause; hospitalization for cardiac event; any major arrhythmic event defined by arrhythmic cardiac arrest, sustained ventricular tachycard</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Morphological end-point</measure>
    <time_frame>five years after inclusion</time_frame>
    <description>Alteration of left ventricular (LV) function defined by a decrease in LVEF as compared to the initial evaluation (≥10%, or occurrence of a new wall motion abnormality assessed the same imaging technic, i.e. echocardiography or CMR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional end-point</measure>
    <time_frame>five years after inclusion</time_frame>
    <description>alteration of exercise capacity, defined by a reduction ≥10% of peak VO2, not explained by training changes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arrhythmic end-point</measure>
    <time_frame>five years after inclusion</time_frame>
    <description>Occurrence of a non-sustained VT (NSVT), defined as a tachycardia originating in the ventricle &gt;100 beats/min and lasting ≥3 beats but less than 30 seconds.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Athletes With Isolated Non-ischemic LGE With no Underlying &quot;Labelled&quot; Cardiomyopathy</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>non-ischemic scar</intervention_name>
    <description>non-ischemic LGE with no underlying &quot;labelled&quot; cardiomyopathy is detected on CMR</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Any athlete, aged of more than 15 years, symptomatic or not, in whom non-ischemic LGE with&#xD;
        no underlying &quot;labelled&quot; cardiomyopathy is detected on CMR.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any athlete, aged of more than 15 years, symptomatic or not,&#xD;
&#xD;
          -  in whom non-ischemic LGE with no underlying &quot;labelled&quot; cardiomyopathy is detected on&#xD;
             CMR. Scare of an acute myocarditis will also be included.&#xD;
&#xD;
        Athletes will be defined by a practice of ≥4 hours/week of sport activity and/or&#xD;
        competitive sport activity at the time of the assessment which triggered the realization of&#xD;
        the 1st CMR.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Athletes with any unequivocal cardiac disease that might explain the LGE (i.e.&#xD;
             hypertrophic cardiomyopathy, ischemic cardiac disease). In case of borderline or&#xD;
             doubtful diagnosis the athlete can still be included (for example an athlete with a&#xD;
             dilated LV and borderline function, or with borderline wall thickness).&#xD;
&#xD;
          -  Patients who refuse their participation in the study.&#xD;
&#xD;
          -  Patients under legal protection or deprived of their liberty.&#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>Frederic FC SCHNELL, MD</last_name>
    <role>Study Director</role>
    <affiliation>Rennes University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kristell KC COAT</last_name>
    <phone>2 99 28 25 55</phone>
    <phone_ext>+33</phone_ext>
    <email>kristell.coat@chu-rennes.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Direction de la recherche</last_name>
    <phone>2 99 28 25 55</phone>
    <phone_ext>+33</phone_ext>
    <email>drc@chu-rennes.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Baker IDI Heart and Diabetes Institute</name>
      <address>
        <city>Melbourne</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>André La Gerche, PH-PD</last_name>
    </contact>
    <investigator>
      <last_name>André La Gerche, PH-PD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospital Gasthuisberg</name>
      <address>
        <city>Leuven</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Guido Claassen, MD</last_name>
    </contact>
    <investigator>
      <last_name>Guido Claassen</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU de Rennes</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Frederic FS SCHNELL, MD</last_name>
    </contact>
    <investigator>
      <last_name>Frederic SCHNELL, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saarland University</name>
      <address>
        <city>Sarrebruck</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jurgen Scharhag, PH-PD</last_name>
    </contact>
    <investigator>
      <last_name>Jurgen Scharhag, PH-PD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Center of Luxembourg</name>
      <address>
        <city>Luxembourg</city>
        <country>Luxembourg</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Axel Urhausen, PH-PD</last_name>
    </contact>
    <investigator>
      <last_name>Axel Urhausen, PH-PD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St. George's University of London</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Mickael Papadakis, MD</last_name>
    </contact>
    <investigator>
      <last_name>Mickael Papadakis, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>France</country>
    <country>Germany</country>
    <country>Luxembourg</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 17, 2018</last_update_submitted>
  <last_update_submitted_qc>December 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Athletes</keyword>
  <keyword>Late gadolinium enhancement</keyword>
  <keyword>fibrosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiomyopathies</mesh_term>
  </condition_browse>
  <!-- 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/NCT03780231
org study id: 35RC18_3026_EISCAR
nct id: NCT03780231
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The prognostic relevance of isolated non-ischemic LGE (i.e. with no underlying "labelled"
      cardiomyopathy) is unclear, and current guidelines to not state on the clearance of athlete
      with this type of findings as regards to competitive or intense sport practice.

      The principal objective of the study is to evaluate during a five-years follow up, the
      clinical outcome of athletes with this kind of findings. The secondary objective is the
      determination of prognostic factors. The management and follow-up of the athletes will be let
      at the appraisal of each center.
The presence of a scar, assessed by late gadolinium enhancement (LGE) on cardiac resonance
      imaging (CMR), is associated with a poor prognosis in patients with ischemic heart disease or
      cardiomyopathy. But the prognostic relevance of isolated non-ischemic LGE (i.e. with no
      underlying "labelled" cardiomyopathy) is unclear, and current guidelines do not state on the
      clearance of athlete with this type of findings as regards to competitive or intense sport
      practice.

      The objective of the study is to evaluate the clinical outcome of athletes with isolated
      non-ischemic LGE with no underlying "labelled" cardiomyopathy during a five-years follow-up.
      The secondary objective is the determination of prognostic factors based on the baseline
      inclusion data: indication of CMR (i.e. symptoms, abnormal ECG, presence and morphology of
      arrhythmias, abnormal echocardiography); localization and amount of LGE, left and right
      ventricular geometry and function, characteristics of sport practice (amount, type,
      competition).

      The management of the athletes will be let at the appraisal of each centre, as regards to the
      initial assessment, the follow-up and the medical clearance for competitive sports
      participation. Nevertheless, due to the absence of consensus, we propose that the patient
      should at least undergo clinical examination, ECG, echocardiography, cardiopulmonary exercise
      test (CPET) and holter ECG each year. A CMR should be performed at one and five years.
observational model: Cohort
time perspective: Prospective
measure: Occurrence of a major cardiac event
time frame: five years after inclusion
description: During a follow-up of 5 years, occurrence of a major cardiac event defined by either: death, death of cardiovascular cause; hospitalization for cardiac event; any major arrhythmic event defined by arrhythmic cardiac arrest, sustained ventricular tachycard
measure: Morphological end-point
time frame: five years after inclusion
description: Alteration of left ventricular (LV) function defined by a decrease in LVEF as compared to the initial evaluation (≥10%, or occurrence of a new wall motion abnormality assessed the same imaging technic, i.e. echocardiography or CMR)
measure: Functional end-point
time frame: five years after inclusion
description: alteration of exercise capacity, defined by a reduction ≥10% of peak VO2, not explained by training changes
measure: Arrhythmic end-point
time frame: five years after inclusion
description: Occurrence of a non-sustained VT (NSVT), defined as a tachycardia originating in the ventricle >100 beats/min and lasting ≥3 beats but less than 30 seconds.
intervention type: Other
intervention name: non-ischemic scar
description: non-ischemic LGE with no underlying "labelled" cardiomyopathy is detected on CMR
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
healthy volunteers: No
last name: Frederic FC SCHNELL, MD
role: Study Director
affiliation: Rennes University Hospital
last name: Kristell KC COAT
phone: 2 99 28 25 55
phone ext: +33
email: kristell.coat@chu-rennes.fr
last name: Direction de la recherche
phone: 2 99 28 25 55
phone ext: +33
email: drc@chu-rennes.fr
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
country: Australia
country: Belgium
country: France
country: Germany
country: Luxembourg
country: United Kingdom
responsible party type: Sponsor
mesh term: Cardiomyopathies