<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/NCT03230136</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL17_0174</org_study_id>
    <nct_id>NCT03230136</nct_id>
  </id_info>
  <brief_title>Protection During Cardiac Surgery.</brief_title>
  <acronym>ProCCard</acronym>
  <official_title>Protection During Cardiac Surgery.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This trial investigates whether a multimodal cardioprotection per-surgery therapeutic&#xD;
      strategy could reduce myocardial injury in patients undergoing cardiac surgery compared to&#xD;
      traditional management. The primary endpoint is the AUC (area under the curve) of the&#xD;
      hypersensitive troponin I. Blood samples will be collected during the 72 hours following the&#xD;
      aortic cross-unclamping. This trial is a French, multicenter, randomized, single-blinded and&#xD;
      controlled trial. 210 patients will be enrolled with a clinical follow-up during 30 days.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 3, 2018</start_date>
  <completion_date type="Actual">July 3, 2019</completion_date>
  <primary_completion_date type="Actual">May 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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the plasma concentration versus time curve (AUC) of Hypersensitive Troponin I</measure>
    <time_frame>at 72 hours</time_frame>
    <description>Area under the plasma concentration versus time curve (AUC) of Hypersensitive Troponin I determined for each patient with the serial measurement from of troponin I assays.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse events incidence during the first 30 days following surgery of the multimodal cardioprotection strategy</measure>
    <time_frame>30 days</time_frame>
    <description>Adverse events will include death, myocardial infarction, heart failure,arrhythmia requiring medical therapy, neurological disorder such as stroke,respiratory insufficiency, any infectious event, major bleeding requiring transfusion of ≥ 5 U packed red blood cells or surgical intervention or surgical complication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Troponin I serum peak value</measure>
    <time_frame>72 hours</time_frame>
    <description>Highest serum value recorded for each patient within 72 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Troponin I serum value</measure>
    <time_frame>24 hours</time_frame>
    <description>Serum value recorded for each patient within 24 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of mechanical ventilation</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay in intensive care unit (ICU)</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay in hospital</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Index Gravity Score (IGS II, the scoring system measuring the severity of disease for patients admitted to ICU)</measure>
    <time_frame>24 hours</time_frame>
    <description>Index Gravity Score provides an estimate of the risk of death: the higher the score is, the higher the risk to die is. The maximum score is 163. The Index Gravity Score includes 17 variables: 12 physiology variables, age, type of admission (scheduled surgical, unscheduled surgical, or medical), and three underlying disease variables (acquired immunodeficiency syndrome, metastatic cancer, and hematologic malignancy).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with catecholaminergic support</measure>
    <time_frame>baseline and 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose of catecholaminergic support</measure>
    <time_frame>baseline and 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-level version of EQ-5D (EQ-5D-3L) health status score (quality of life score)</measure>
    <time_frame>Baseline and 30 days</time_frame>
    <description>The 3-level version of EQ-5D consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).It comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of death</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">210</enrollment>
  <condition>Thoracic Surgery</condition>
  <condition>Cardiopulmonary Bypass</condition>
  <arm_group>
    <arm_group_label>Multimodal cardioprotection therapeutic strategy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional anesthetic and therapeutic</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>standard anesthetic procedure No intervention (Control).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>multimodal cardioprotection strategy</intervention_name>
    <description>Multimodal cardioprotection therapeutic strategy will include (1) remote ischemic preconditioning, (2) volatile anesthetic sevoflurane-induced preconditioning, (3) blood glucose control every 30 minutes during cardiac surgery, (4) temporary respiratory acidosis prior to the aortic cross-unclamping and (5) gradual restoration of blood flow after aortic cross-unclamping (gentle reperfusion).</description>
    <arm_group_label>Multimodal cardioprotection therapeutic strategy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>standard anesthetic procedure</intervention_name>
    <description>standard anesthetic procedure will include: anesthesia under propofol throughout the cardiac surgery, blood glucose control every 60 minutes, arterial pH maintained at 7.40, theoric blood flow restored at the earliest after aortic cross-unclamping.</description>
    <arm_group_label>Traditional anesthetic and therapeutic</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years old&#xD;
&#xD;
          -  Aortic valve surgery (aortic valve replacement associated or not with coronary artery&#xD;
             bypass graft, Bentall surgery or Tirone David surgery)&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Emergency surgery&#xD;
&#xD;
          -  Redo surgery&#xD;
&#xD;
          -  Patient treated with Nicorandil, repaglinid or sulfonylurea 48 hours prior to surgery&#xD;
&#xD;
          -  Low cardiac output requiring catecholamine infusion or circulatory assistance prior to&#xD;
             surgery&#xD;
&#xD;
          -  Severe renal failure: dialysis or glomerular filtration rate &lt; 30 mL/min&#xD;
&#xD;
          -  Severe liver failure (spontaneous INR &gt;2)&#xD;
&#xD;
          -  Severe respiratory insufficiency (VEMS &lt;40% of predicted value)&#xD;
&#xD;
          -  Contra-indication to sevoflurane and propofol&#xD;
&#xD;
          -  Myocardial infarction &lt; 7 days&#xD;
&#xD;
          -  Severe upper limb arterial disease&#xD;
&#xD;
          -  Heparin-induced thrombopenia&#xD;
&#xD;
          -  Active infection under antibiotic treatment&#xD;
&#xD;
          -  Any other surgery combined with the aortic valve surgery: myotomia of Morrow&#xD;
             (hypertrophic myocardiopathy), treatment of heart rhythm disorder, inter-atrial&#xD;
             communication closure, mitral valve replacement, tricuspid valve replacement,&#xD;
             pulmonary valve replacement.&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Currently participating in another trial which may interfere with ProCCard results&#xD;
&#xD;
          -  Not benefiting from a social insurance or similar system&#xD;
&#xD;
          -  Patient under legal protection&#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>Jean-Luc FELLAHI</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospices Civils de Lyon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CH Annecy</name>
      <address>
        <city>Annecy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service d'Anesthésie-Réanimation, Hôpital Cardiologique et Pneumologique Louis Pradel</name>
      <address>
        <city>Bron</city>
        <zip>69500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Caen</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>service de Chirurgie Cardiaque CHU Gabriel Montpied</name>
      <address>
        <city>Clermont-Ferrand</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unité de Réanimation Cardiovasculaire et Thoracique, Hôpital Michallon</name>
      <address>
        <city>Grenoble</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique de la sauvegarde</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Arnault Tzanck - Saint-Laurent du Var</name>
      <address>
        <city>Saint-Laurent-du-Var</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Saint-Etienne</name>
      <address>
        <city>Saint-Étienne</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>July 3, 2020</last_update_submitted>
  <last_update_submitted_qc>July 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Myocardial injury</keyword>
  <keyword>Ischemia reperfusion</keyword>
  <keyword>cardiac surgery</keyword>
  <keyword>cardioprotection</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_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/NCT03230136
org study id: 69HCL17_0174
nct id: NCT03230136
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This trial investigates whether a multimodal cardioprotection per-surgery therapeutic
      strategy could reduce myocardial injury in patients undergoing cardiac surgery compared to
      traditional management. The primary endpoint is the AUC (area under the curve) of the
      hypersensitive troponin I. Blood samples will be collected during the 72 hours following the
      aortic cross-unclamping. This trial is a French, multicenter, randomized, single-blinded and
      controlled trial. 210 patients will be enrolled with a clinical follow-up during 30 days.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Area under the plasma concentration versus time curve (AUC) of Hypersensitive Troponin I
time frame: at 72 hours
description: Area under the plasma concentration versus time curve (AUC) of Hypersensitive Troponin I determined for each patient with the serial measurement from of troponin I assays.
measure: Adverse events incidence during the first 30 days following surgery of the multimodal cardioprotection strategy
time frame: 30 days
description: Adverse events will include death, myocardial infarction, heart failure,arrhythmia requiring medical therapy, neurological disorder such as stroke,respiratory insufficiency, any infectious event, major bleeding requiring transfusion of ≥ 5 U packed red blood cells or surgical intervention or surgical complication
measure: Troponin I serum peak value
time frame: 72 hours
description: Highest serum value recorded for each patient within 72 hours
measure: Troponin I serum value
time frame: 24 hours
description: Serum value recorded for each patient within 24 hours
measure: Length of mechanical ventilation
time frame: 30 days
measure: Length of stay in intensive care unit (ICU)
time frame: 30 days
measure: Length of stay in hospital
time frame: 30 days
measure: Index Gravity Score (IGS II, the scoring system measuring the severity of disease for patients admitted to ICU)
time frame: 24 hours
description: Index Gravity Score provides an estimate of the risk of death: the higher the score is, the higher the risk to die is. The maximum score is 163. The Index Gravity Score includes 17 variables: 12 physiology variables, age, type of admission (scheduled surgical, unscheduled surgical, or medical), and three underlying disease variables (acquired immunodeficiency syndrome, metastatic cancer, and hematologic malignancy).
measure: Number of participants with catecholaminergic support
time frame: baseline and 30 days
measure: Dose of catecholaminergic support
time frame: baseline and 30 days
measure: 3-level version of EQ-5D (EQ-5D-3L) health status score (quality of life score)
time frame: Baseline and 30 days
description: The 3-level version of EQ-5D consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).It comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
measure: number of death
time frame: 30 days
arm group label: Multimodal cardioprotection therapeutic strategy
arm group type: Experimental
arm group label: Traditional anesthetic and therapeutic
arm group type: Active Comparator
description: standard anesthetic procedure No intervention (Control).
intervention type: Other
intervention name: multimodal cardioprotection strategy
description: Multimodal cardioprotection therapeutic strategy will include (1) remote ischemic preconditioning, (2) volatile anesthetic sevoflurane-induced preconditioning, (3) blood glucose control every 30 minutes during cardiac surgery, (4) temporary respiratory acidosis prior to the aortic cross-unclamping and (5) gradual restoration of blood flow after aortic cross-unclamping (gentle reperfusion).
arm group label: Multimodal cardioprotection therapeutic strategy
intervention type: Other
intervention name: standard anesthetic procedure
description: standard anesthetic procedure will include: anesthesia under propofol throughout the cardiac surgery, blood glucose control every 60 minutes, arterial pH maintained at 7.40, theoric blood flow restored at the earliest after aortic cross-unclamping.
arm group label: Traditional anesthetic and therapeutic
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Luc FELLAHI
role: Principal Investigator
affiliation: Hospices Civils de Lyon
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Anesthetics