<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/NCT01660828</url>
  </required_header>
  <id_info>
    <org_study_id>EXTROP2</org_study_id>
    <nct_id>NCT01660828</nct_id>
  </id_info>
  <brief_title>Exercise Test and Cardiac Injury</brief_title>
  <official_title>The Effect of Remote Ischemic Preconditioning on Plasma Troponin I Appearance After a Standardized Cycling Test in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Radboud University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Strenuous exercise in apparent healthy individuals increases plasma (high sensitive) troponin&#xD;
      levels. The underlying mechanism is not yet elucidated, but could be explained by changes due&#xD;
      to a mismatch in oxygen demand and supply that mimic those of ischemia and reperfusion&#xD;
      injury. If the mechanism underlying the troponin release during exercise is similar to that&#xD;
      of ischemia reperfusion injury (IRI), than it should be susceptible to remote ischemic&#xD;
      preconditioning (RIPC) as RIPC is a well validated technique to reduce IRI. To test this&#xD;
      hypothesis healthy volunteers underwent a strenuous exercise test with or without preceding&#xD;
      RIPC.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">January 2012</completion_date>
  <primary_completion_date type="Actual">December 2011</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>serum level of high sensitive troponin at several timepoints</measure>
    <time_frame>timepoints t= baseline, 0, 1, 2, 3,4 and 8 hours after finishing exercise</time_frame>
    <description>serum level of high sensitive troponin in response to intensive exercise test with or without RIPC at several timepoints</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Cardiovascular Disease</condition>
  <arm_group>
    <arm_group_label>Intensive cycling test preceded by RIPC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intensive cycling test preceded by a RIPC protocol.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No intervention/ RIPC</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Intensive cycling test not preceded by a RIPC protocol.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>remote ischemic preconditioning (RIPC)</intervention_name>
    <description>RIPC protocol which consist of three 5-min cycles of bilateral forearm ischemia</description>
    <arm_group_label>Intensive cycling test preceded by RIPC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age: 18-45 year&#xD;
&#xD;
          -  willing to sign informed consent&#xD;
&#xD;
          -  healthy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  hypertension (systolic blood pressure &gt;140 mmHg or diastolic blood pressure &gt; 90 mmHg)&#xD;
&#xD;
          -  any cardiovascular abnormality in past medical history, physical examination or ECG,&#xD;
             including QTc interval&#xD;
&#xD;
          -  drug abuse&#xD;
&#xD;
          -  alcohol abuse (&gt; 3 units/day)&#xD;
&#xD;
          -  smoking during the last 2 years&#xD;
&#xD;
          -  BMI &gt;30 kg/m2&#xD;
&#xD;
          -  inability to perform bicycle test&#xD;
&#xD;
          -  the presence of an absolute or relative contra-indication for exercise (table 2 in&#xD;
             protocol)&#xD;
&#xD;
          -  the presence of diabetes (fasting glucose &gt; 6.9 mmol/L, non-fasting glucose &gt;11.0&#xD;
             mmol/L; if non-fasting glucose is &gt; 6.9 mmol/L, blood glucose measurement will be&#xD;
             repeated in fasting condition and should then not exceed 6.9 mmol/L)&#xD;
&#xD;
          -  total cholesterol in blood 6.6 mmol/L or higher&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>G. Rongen, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Radboud University Nijmegen Medial Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Radboud University Nijmegen Medical Centre</name>
      <address>
        <city>Nijmegen</city>
        <zip>6500 HB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>August 2011</verification_date>
  <study_first_submitted>July 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <last_update_submitted>August 8, 2012</last_update_submitted>
  <last_update_submitted_qc>August 8, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 9, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Exercise induced (high sensitive) troponin release</keyword>
  <keyword>Ischemia reperfusion injury</keyword>
  <keyword>Remote ischemic preconditioning</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</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/NCT01660828
org study id: EXTROP2
nct id: NCT01660828
lead sponsor: 
has dmc: No
Strenuous exercise in apparent healthy individuals increases plasma (high sensitive) troponin
      levels. The underlying mechanism is not yet elucidated, but could be explained by changes due
      to a mismatch in oxygen demand and supply that mimic those of ischemia and reperfusion
      injury. If the mechanism underlying the troponin release during exercise is similar to that
      of ischemia reperfusion injury (IRI), than it should be susceptible to remote ischemic
      preconditioning (RIPC) as RIPC is a well validated technique to reduce IRI. To test this
      hypothesis healthy volunteers underwent a strenuous exercise test with or without preceding
      RIPC.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: serum level of high sensitive troponin at several timepoints
time frame: timepoints t= baseline, 0, 1, 2, 3,4 and 8 hours after finishing exercise
description: serum level of high sensitive troponin in response to intensive exercise test with or without RIPC at several timepoints
arm group label: Intensive cycling test preceded by RIPC
arm group type: Active Comparator
description: Intensive cycling test preceded by a RIPC protocol.
arm group label: No intervention/ RIPC
arm group type: No Intervention
description: Intensive cycling test not preceded by a RIPC protocol.
intervention type: Other
intervention name: remote ischemic preconditioning (RIPC)
description: RIPC protocol which consist of three 5-min cycles of bilateral forearm ischemia
arm group label: Intensive cycling test preceded by RIPC
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: G. Rongen, MD, PhD
role: Principal Investigator
affiliation: Radboud University Nijmegen Medial Centre
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Cardiovascular Diseases