<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/NCT03305094</url>
  </required_header>
  <id_info>
    <org_study_id>CONDOR-21082</org_study_id>
    <nct_id>NCT03305094</nct_id>
  </id_info>
  <brief_title>The Effect of Remote Ischemic Preconditioning in Aortic Valve Replacement Surgery</brief_title>
  <official_title>The Effect of Remote Ischemic Preconditioning in Aortic Valve Replacement Surgery : a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laval University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Laval University</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 study objective is to verify if a non-invasive remote ischemic preconditioning procedure&#xD;
      (blood pressure cuff on the arm) is cardioprotective when applied before an aortic valve&#xD;
      replacement surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 11, 2014</start_date>
  <completion_date type="Anticipated">December 1, 2024</completion_date>
  <primary_completion_date type="Actual">July 1, 2020</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>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized controlled prospective trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participant is blinded to group assignment</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in biochemical markers of myocardial ischemia</measure>
    <time_frame>6, 12, 24 and 48 hours post-operatively</time_frame>
    <description>Troponin T-HS and CK-MB concentration</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post-operative complications</measure>
    <time_frame>post-operatively until 30 days</time_frame>
    <description>Monitoring the safety of the strategy by monitoring post-operative complications</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Aortic Valve Stenosis</condition>
  <condition>Cardiopulmonary Bypass</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sham remote ischemic preconditioning on the right arm is induced with a blood pressure cuff inflation at 20 mm Hg for 5 min and followed by a 5 min reperfusion at 0 mm Hg. The sham ischemia-reperfusion cycle is performed 3 times for a total of 30 min. This procedure is done after anesthetic induction, but before the patient is placed on cardiopulmonary bypass.&#xD;
A 20 mm Hg blood pressure cuff on the right arm does not induce ischemia.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Remote ischemic preconditioning on the right arm is induced with a blood pressure cuff inflation at 200 mm Hg for 5 min and followed by a 5 min reperfusion at 0 mm Hg. The ischemia-reperfusion cycle is performed 3 times for a total of 30 min. This procedure is done after anesthetic induction, but before the patient is placed on cardiopulmonary bypass.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood pressure cuff inflation</intervention_name>
    <description>Cuff pressure for ischemia sham is 20 mm Hg, ischemia is 200 mm Hg and reperfusion is 0 mm Hg</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Planned isolated aortic valve replacement (stenosis based)&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Left ventricular dysfunction (LVEF&lt; 50%)&#xD;
&#xD;
          -  Myocardial Infarct (&lt; 7days)&#xD;
&#xD;
          -  Coronary artery disease (documented with &gt;50% stenosis)&#xD;
&#xD;
          -  Coronary artery bypass grafting&#xD;
&#xD;
          -  Chronic renal insufficiency (creatinine &gt;175 mmol/L or dialysis)&#xD;
&#xD;
          -  Endocarditis&#xD;
&#xD;
          -  Sternotomy redo&#xD;
&#xD;
          -  Deep vein thrombosis to the compressed limb&#xD;
&#xD;
          -  Emergency procedure&#xD;
&#xD;
          -  TAVI procedure&#xD;
&#xD;
          -  Planned off pump coronary artery bypass&#xD;
&#xD;
          -  MAZE procedure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pierre Voisine, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Laval</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Laval</name>
      <address>
        <city>Quebec City</city>
        <state>Quebec</state>
        <zip>G1V 4G5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>March 9, 2023</last_update_submitted>
  <last_update_submitted_qc>March 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Laval University</investigator_affiliation>
    <investigator_full_name>Pierre Voisine</investigator_full_name>
    <investigator_title>Cardiac surgeon</investigator_title>
  </responsible_party>
  <keyword>Remote ischemic preconditioning</keyword>
  <keyword>Myocardial infarction</keyword>
  <keyword>Cardiac surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Valve Stenosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03305094
org study id: CONDOR-21082
nct id: NCT03305094
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study objective is to verify if a non-invasive remote ischemic preconditioning procedure
      (blood pressure cuff on the arm) is cardioprotective when applied before an aortic valve
      replacement surgery.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled prospective trial
primary purpose: Treatment
masking: Single (Participant)
masking description: Participant is blinded to group assignment
measure: Change in biochemical markers of myocardial ischemia
time frame: 6, 12, 24 and 48 hours post-operatively
description: Troponin T-HS and CK-MB concentration
measure: Post-operative complications
time frame: post-operatively until 30 days
description: Monitoring the safety of the strategy by monitoring post-operative complications
arm group label: Control group
arm group type: Active Comparator
description: Sham remote ischemic preconditioning on the right arm is induced with a blood pressure cuff inflation at 20 mm Hg for 5 min and followed by a 5 min reperfusion at 0 mm Hg. The sham ischemia-reperfusion cycle is performed 3 times for a total of 30 min. This procedure is done after anesthetic induction, but before the patient is placed on cardiopulmonary bypass.
A 20 mm Hg blood pressure cuff on the right arm does not induce ischemia.
arm group label: Intervention group
arm group type: Experimental
description: Remote ischemic preconditioning on the right arm is induced with a blood pressure cuff inflation at 200 mm Hg for 5 min and followed by a 5 min reperfusion at 0 mm Hg. The ischemia-reperfusion cycle is performed 3 times for a total of 30 min. This procedure is done after anesthetic induction, but before the patient is placed on cardiopulmonary bypass.
intervention type: Procedure
intervention name: Blood pressure cuff inflation
description: Cuff pressure for ischemia sham is 20 mm Hg, ischemia is 200 mm Hg and reperfusion is 0 mm Hg
arm group label: Control group
arm group label: Intervention group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pierre Voisine, MD
role: Principal Investigator
affiliation: University Laval
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Laval University
investigator full name: Pierre Voisine
investigator title: Cardiac surgeon
mesh term: Aortic Valve Stenosis
sharing ipd: No