<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/NCT03304483</url>
  </required_header>
  <id_info>
    <org_study_id>84542</org_study_id>
    <nct_id>NCT03304483</nct_id>
  </id_info>
  <brief_title>Cardiovascular Responses to Spartathlon Running</brief_title>
  <acronym>Spartathlon</acronym>
  <official_title>Cardiovascular Effects of Ultramarathon Running</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aristotle University Of Thessaloniki</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aristotle University Of Thessaloniki</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to examine the cardiovascular effects of ultramarathon running and&#xD;
      their relation to performance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the study is to determine the changes of cardiovascular morphology and&#xD;
      function after an ultramarathon race. 50 entrants to the &quot;Spartathlon 2017&quot; 246-km running&#xD;
      race will participate in the study. Cardiac and arterial morphology and function tests will&#xD;
      be conducted one day before the race and within 20 minutes of race completion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 29, 2017</start_date>
  <completion_date type="Actual">June 30, 2021</completion_date>
  <primary_completion_date type="Actual">December 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>athletes participating in the ultra marathon running</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Before and after the race</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change of right ventricular function after one day ultra-marathon running</measure>
    <time_frame>before and after 1 day running</time_frame>
    <description>Echocardiographic study of left ventricular function</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of left ventricular function after one day ultra-marathon running</measure>
    <time_frame>before and after 1 day running</time_frame>
    <description>Echocardiographic study of left ventricular function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of carotid artery function after one day ultra-marathon running</measure>
    <time_frame>before and after 1 day running</time_frame>
    <description>Echocardiographic study of carotid arteries</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Disorder Heart</condition>
  <arm_group>
    <arm_group_label>Athletes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>246-km running</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>246-km running</intervention_name>
    <description>Spartathlon 2017</description>
    <arm_group_label>Athletes</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Runners at least 18 years old, healthy and sufficiently trained.&#xD;
&#xD;
          -  Runners being accepted to participate in the Spartathlon race according to the&#xD;
             eligibility criteria (http://www.spartathlon.gr/en/registration-en.html)&#xD;
&#xD;
          -  Runners who will volunteer to be examined pre- and post the race&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Runners with chronic diseases&#xD;
&#xD;
          -  Runners receiving any medication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>67 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Evangelia Kouidi, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aristotle University of Thessaloniki, Greece</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Laboratory of Sports Medicine</name>
      <address>
        <city>Thessaloniki</city>
        <zip>546 35</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <reference>
    <citation>Seedhouse EL, Walsh ML, Blaber AP. Heart rate, mean arterial blood pressure, and pulmonary function changes associated with an ultraendurance triathlon. Wilderness Environ Med. 2006 Winter;17(4):240-5. doi: 10.1580/pr27-05-r1.1.</citation>
    <PMID>17219787</PMID>
  </reference>
  <reference>
    <citation>Millet GP, Millet GY. Ultramarathon is an outstanding model for the study of adaptive responses to extreme load and stress. BMC Med. 2012 Jul 19;10:77. doi: 10.1186/1741-7015-10-77.</citation>
    <PMID>22812424</PMID>
  </reference>
  <reference>
    <citation>Cote AT, Phillips AA, Foulds HJ, Charlesworth SA, Bredin SS, Burr JF, Koehle MS, Warburton DE. Sex differences in cardiac function after prolonged strenuous exercise. Clin J Sport Med. 2015 May;25(3):276-83. doi: 10.1097/JSM.0000000000000130.</citation>
    <PMID>25010150</PMID>
  </reference>
  <reference>
    <citation>Jee H, Park J, Oh JG, Lee YH, Shin KA, Kim YJ. Effect of a prolonged endurance marathon on vascular endothelial and inflammation markers in runners with exercise-induced hypertension. Am J Phys Med Rehabil. 2013 Jun;92(6):513-22. doi: 10.1097/PHM.0b013e31829232db.</citation>
    <PMID>23685440</PMID>
  </reference>
  <results_reference>
    <citation>Blaber AP, Walsh ML, Carter JB, Seedhouse EL, Walker VE. Cardiopulmonary physiology and responses of ultramarathon athletes to prolonged exercise. Can J Appl Physiol. 2004 Oct;29(5):544-63. doi: 10.1139/h04-035.</citation>
    <PMID>15507692</PMID>
  </results_reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>July 19, 2023</last_update_submitted>
  <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aristotle University Of Thessaloniki</investigator_affiliation>
    <investigator_full_name>Evangelia Kouidi</investigator_full_name>
    <investigator_title>Cardiologist, Professor of Sports Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No personal details will be shared. Only the results of the measurements will be available</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/NCT03304483
org study id: 84542
nct id: NCT03304483
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to examine the cardiovascular effects of ultramarathon running and
      their relation to performance.
The purpose of the study is to determine the changes of cardiovascular morphology and
      function after an ultramarathon race. 50 entrants to the "Spartathlon 2017" 246-km running
      race will participate in the study. Cardiac and arterial morphology and function tests will
      be conducted one day before the race and within 20 minutes of race completion.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: athletes participating in the ultra marathon running
primary purpose: Screening
masking: None (Open Label)
masking description: Before and after the race
measure: Change of right ventricular function after one day ultra-marathon running
time frame: before and after 1 day running
description: Echocardiographic study of left ventricular function
measure: Change of left ventricular function after one day ultra-marathon running
time frame: before and after 1 day running
description: Echocardiographic study of left ventricular function
measure: Change of carotid artery function after one day ultra-marathon running
time frame: before and after 1 day running
description: Echocardiographic study of carotid arteries
arm group label: Athletes
arm group type: Experimental
description: 246-km running
intervention type: Other
intervention name: 246-km running
description: Spartathlon 2017
arm group label: Athletes
criteria: 
gender: All
minimum age: 18 Years
maximum age: 67 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Evangelia Kouidi, Professor
role: Principal Investigator
affiliation: Aristotle University of Thessaloniki, Greece
facility: 
country: Greece
citation: Seedhouse EL, Walsh ML, Blaber AP. Heart rate, mean arterial blood pressure, and pulmonary function changes associated with an ultraendurance triathlon. Wilderness Environ Med. 2006 Winter;17(4):240-5. doi: 10.1580/pr27-05-r1.1.
PMID: 17219787
citation: Millet GP, Millet GY. Ultramarathon is an outstanding model for the study of adaptive responses to extreme load and stress. BMC Med. 2012 Jul 19;10:77. doi: 10.1186/1741-7015-10-77.
PMID: 22812424
citation: Cote AT, Phillips AA, Foulds HJ, Charlesworth SA, Bredin SS, Burr JF, Koehle MS, Warburton DE. Sex differences in cardiac function after prolonged strenuous exercise. Clin J Sport Med. 2015 May;25(3):276-83. doi: 10.1097/JSM.0000000000000130.
PMID: 25010150
citation: Jee H, Park J, Oh JG, Lee YH, Shin KA, Kim YJ. Effect of a prolonged endurance marathon on vascular endothelial and inflammation markers in runners with exercise-induced hypertension. Am J Phys Med Rehabil. 2013 Jun;92(6):513-22. doi: 10.1097/PHM.0b013e31829232db.
PMID: 23685440
citation: Blaber AP, Walsh ML, Carter JB, Seedhouse EL, Walker VE. Cardiopulmonary physiology and responses of ultramarathon athletes to prolonged exercise. Can J Appl Physiol. 2004 Oct;29(5):544-63. doi: 10.1139/h04-035.
PMID: 15507692
responsible party type: Principal Investigator
investigator affiliation: Aristotle University Of Thessaloniki
investigator full name: Evangelia Kouidi
investigator title: Cardiologist, Professor of Sports Medicine
mesh term: Heart Diseases
sharing ipd: No
ipd description: No personal details will be shared. Only the results of the measurements will be available