<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/NCT02230098</url>
  </required_header>
  <id_info>
    <org_study_id>1-10-72-124-13</org_study_id>
    <nct_id>NCT02230098</nct_id>
  </id_info>
  <brief_title>Effects of Remote Ischemic Conditioning on Myocardial Perfusion in Humans</brief_title>
  <acronym>CONDI-PET</acronym>
  <official_title>Effects of Remote Ischemic Conditioning on Myocardial Perfusion in Humans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Leducq Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cardiovascular disease is the second leading cause of death in Denmark, and ischemic heart&#xD;
      disease accounts for the bulk of it. The purpose of this study is to clarify whether a&#xD;
      mechanical method of remote ischemic conditioning in the form of short-term obstruction of&#xD;
      the blood supply to the arm, can improve the heart's blood supply in patients with ischemic&#xD;
      heart disease. This will be attempted through experiments on patients with ischemic heart&#xD;
      disease and experimental animal studies with simulated cardiovascular disease.&#xD;
&#xD;
      This study will help to clarify whether remote ischemic preconditioning can be used to treat&#xD;
      patients with ischemic heart disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2013</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in myocardial blood flow (MBF)</measure>
    <time_frame>2 hours - Measurements will be done immediately before/after intervention</time_frame>
    <description>MBF before and after intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in MBF between ischemic and non-ischemic myocardial territories.</measure>
    <time_frame>2 hours - Measurements will be done immediately before/after intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in MBF between patients with and without ischemic heart disease detectable by Rb82-PET.</measure>
    <time_frame>2 hours - Measurements will be done immediately before/after intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardioprotection by the intervention measured by an increase in myocardial salvage in isolated rabbit hearts studied in a Langendorff model.</measure>
    <time_frame>6 months following last patient last visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relation between changes in MBF and myocardial salvage in rabbit hearts</measure>
    <time_frame>6 months following last patient last visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>• Differences in MBF between regions supplied by coronary arteries subsequently undergoing percutaneous intervention (PCI) and regions supplied by arteries not undergoing PCI</measure>
    <time_frame>6 months following last patient last visit</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Ischemic Heart Disease</condition>
  <arm_group>
    <arm_group_label>Remote Ischemic Conditioning</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>By use of short-term obstruction of the blood supply to the arm</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Before Remote Ischemic Conditioning</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Remote Ischemic Conditioning</intervention_name>
    <arm_group_label>Remote Ischemic Conditioning</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients referred for routine myocardial Rb82-PET scanning at Dept. of Nuclear&#xD;
             Medicine &amp; PET center, Aarhus University Hospital, Skejby, Denmark.&#xD;
&#xD;
          -  Able to understand the written patient information and to give informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients not undergoing Rb82-PET with adenosine stress test.&#xD;
&#xD;
          -  Strenuous exercise (running, bicycling, fitness), intake of beta-blockers or alcohol&#xD;
             intake on the day before and on the day of investigation.&#xD;
&#xD;
          -  Pregnant/nursing women.&#xD;
&#xD;
          -  Fertile women not using contraceptives.&#xD;
&#xD;
          -  Patients in dialysis treatment.&#xD;
&#xD;
          -  Other concomitant disease or treatment that according to the investigator's assessment&#xD;
             makes the patient unsuitable for study participation.&#xD;
&#xD;
          -  Known type 2 diabetes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roni Ranghøj Nielsen, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Cardiology, Aarhus University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hans Erik Bøtker, Prof, MD, PhD, DMSc</last_name>
    <role>Study Director</role>
    <affiliation>Dept. of Cardiology, Aarhus University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aarhus University Hospital</name>
      <address>
        <city>Aarhus</city>
        <state>Region Central Denmark</state>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>November 2013</verification_date>
  <study_first_submitted>June 10, 2013</study_first_submitted>
  <study_first_submitted_qc>August 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>January 15, 2015</last_update_submitted>
  <last_update_submitted_qc>January 15, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 16, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>remote ischemic conditioning</keyword>
  <keyword>ischemic heart disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Ischemia</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/NCT02230098
org study id: 1-10-72-124-13
nct id: NCT02230098
lead sponsor: 
collaborator: 
has dmc: No
Cardiovascular disease is the second leading cause of death in Denmark, and ischemic heart
      disease accounts for the bulk of it. The purpose of this study is to clarify whether a
      mechanical method of remote ischemic conditioning in the form of short-term obstruction of
      the blood supply to the arm, can improve the heart's blood supply in patients with ischemic
      heart disease. This will be attempted through experiments on patients with ischemic heart
      disease and experimental animal studies with simulated cardiovascular disease.

      This study will help to clarify whether remote ischemic preconditioning can be used to treat
      patients with ischemic heart disease.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Changes in myocardial blood flow (MBF)
time frame: 2 hours - Measurements will be done immediately before/after intervention
description: MBF before and after intervention
measure: Difference in MBF between ischemic and non-ischemic myocardial territories.
time frame: 2 hours - Measurements will be done immediately before/after intervention
measure: Difference in MBF between patients with and without ischemic heart disease detectable by Rb82-PET.
time frame: 2 hours - Measurements will be done immediately before/after intervention
measure: Cardioprotection by the intervention measured by an increase in myocardial salvage in isolated rabbit hearts studied in a Langendorff model.
time frame: 6 months following last patient last visit
measure: Relation between changes in MBF and myocardial salvage in rabbit hearts
time frame: 6 months following last patient last visit
measure: • Differences in MBF between regions supplied by coronary arteries subsequently undergoing percutaneous intervention (PCI) and regions supplied by arteries not undergoing PCI
time frame: 6 months following last patient last visit
arm group label: Remote Ischemic Conditioning
arm group type: Experimental
description: By use of short-term obstruction of the blood supply to the arm
arm group label: Before Remote Ischemic Conditioning
arm group type: No Intervention
intervention type: Other
intervention name: Remote Ischemic Conditioning
arm group label: Remote Ischemic Conditioning
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Roni Ranghøj Nielsen, MD, PhD
role: Principal Investigator
affiliation: Department of Cardiology, Aarhus University Hospital
last name: Hans Erik Bøtker, Prof, MD, PhD, DMSc
role: Study Director
affiliation: Dept. of Cardiology, Aarhus University Hospital
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Heart Diseases
mesh term: Myocardial Ischemia
mesh term: Coronary Artery Disease
mesh term: Ischemia