<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/NCT01699230</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-0120</org_study_id>
    <nct_id>NCT01699230</nct_id>
  </id_info>
  <brief_title>Potential Effects of Omega 3 Supplementation on Cardiomyocytes Membranes for Patients With Coronary Atherosclerosis?</brief_title>
  <acronym>CORONOMEGA3</acronym>
  <official_title>Potential Effects of Omega 3 Supplementation on Cardiomyocytes Membranes for Patients With Coronary Atherosclerosis?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Université d'Auvergne</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</source>
  <brief_summary>
    <textblock>
      To show the existence of a atrial cardiomyocytes membranes modification in omega-3&#xD;
      supplemented patients with coronary atherosclerosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Very few human data are currently available on the fatty acid composition of cardiomyocytes&#xD;
      membranes. Preoperative omega-3 supplementation for patients undergoing cardiac surgery with&#xD;
      cardiopulmonary bypass is correlated with a decreased frequency of postoperative&#xD;
      complications in type of arrhythmia atrial fibrillation. Atrial fibrillation is the most&#xD;
      common complication: 30 to 50% after myocardial revascularization. The occurrence of atrial&#xD;
      fibrillation increases morbidity and mortality after surgery for sure. The pathophysiological&#xD;
      mechanisms of common atrial fibrillation treated in heart rhythm units are different from&#xD;
      those of postoperative atrial fibrillation. Indeed, atrial fibrillation is a common disease&#xD;
      primarily of the left atrium, although atrial fibrillation after cardiac surgery is a&#xD;
      multifactorial disease with implication of various pathogens such as inflammation without&#xD;
      precise anatomical support. The preventive use of polyunsaturated fatty acids omega-3&#xD;
      long-chain (LC-AGPIω3), prior cardiac surgery is far from widespread due to a Lack of&#xD;
      information dissemination, by insufficient number of published studies, despite the existence&#xD;
      of a number of ongoing clinical trials and a complete ignorance of biological mechanisms of&#xD;
      action. A human clinical study is needed. In a context of cardiac surgery with&#xD;
      cardiopulmonary bypass and without deleterious side effects of preoperative enrichment in&#xD;
      omega-3, it seems appropriate to conduct a feasibility study to provide information on&#xD;
      structural changes in membranes of cardiomyocytes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2011</start_date>
  <completion_date type="Anticipated">May 2013</completion_date>
  <primary_completion_date type="Anticipated">May 2013</primary_completion_date>
  <phase>Phase 3</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>fatty acid variations</measure>
    <time_frame>at J-21</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>postoperative arrhythmias (atrial fibrillation)</measure>
    <time_frame>at J-21, J0, J7 and J30</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative inflammatory syndrome</measure>
    <time_frame>at J-21, J0, J7 and J30</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Coronary Atherosclerosis</condition>
  <arm_group>
    <arm_group_label>Omega 3 supplemented patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To show the existence of a atrial cardiomyocytes membranes modification in omega-3 supplemented patients with coronary atherosclerosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Omega 3</intervention_name>
    <description>To show the existence of a atrial cardiomyocytes membranes modification in omega-3 supplemented patients with coronary atherosclerosis</description>
    <arm_group_label>Omega 3 supplemented patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men without diabetes,&#xD;
&#xD;
          -  over 50 years with overweight (BMI greater than 25) and&#xD;
&#xD;
          -  without severe obesity (BMI less than 40)&#xD;
&#xD;
          -  Patients who have given their written consent,&#xD;
&#xD;
          -  the beneficiary of a social security system.&#xD;
&#xD;
          -  Elective cardiac surgery with sternotomy and cardiopulmonary bypass for coronary&#xD;
             artery bypass graft.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kasra AZARNOUSH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Patrick LACARIN</last_name>
    <phone>04 73 75 11 95</phone>
    <email>placarin@chu-clermontferrand.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU de Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patrick LACARIN</last_name>
      <phone>04 73 75 11 95</phone>
      <email>placarin@chu-clermontferrand.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>July 13, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>October 1, 2012</last_update_submitted>
  <last_update_submitted_qc>October 1, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 3, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Elective cardiac surgery</keyword>
  <keyword>with sternotomy and</keyword>
  <keyword>cardiopulmonary bypass</keyword>
  <keyword>for coronary artery</keyword>
  <keyword>bypass graft.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atherosclerosis</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial 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/NCT01699230
org study id: CHU-0120
nct id: NCT01699230
lead sponsor: 
collaborator: 
To show the existence of a atrial cardiomyocytes membranes modification in omega-3
      supplemented patients with coronary atherosclerosis.
Very few human data are currently available on the fatty acid composition of cardiomyocytes
      membranes. Preoperative omega-3 supplementation for patients undergoing cardiac surgery with
      cardiopulmonary bypass is correlated with a decreased frequency of postoperative
      complications in type of arrhythmia atrial fibrillation. Atrial fibrillation is the most
      common complication: 30 to 50% after myocardial revascularization. The occurrence of atrial
      fibrillation increases morbidity and mortality after surgery for sure. The pathophysiological
      mechanisms of common atrial fibrillation treated in heart rhythm units are different from
      those of postoperative atrial fibrillation. Indeed, atrial fibrillation is a common disease
      primarily of the left atrium, although atrial fibrillation after cardiac surgery is a
      multifactorial disease with implication of various pathogens such as inflammation without
      precise anatomical support. The preventive use of polyunsaturated fatty acids omega-3
      long-chain (LC-AGPIω3), prior cardiac surgery is far from widespread due to a Lack of
      information dissemination, by insufficient number of published studies, despite the existence
      of a number of ongoing clinical trials and a complete ignorance of biological mechanisms of
      action. A human clinical study is needed. In a context of cardiac surgery with
      cardiopulmonary bypass and without deleterious side effects of preoperative enrichment in
      omega-3, it seems appropriate to conduct a feasibility study to provide information on
      structural changes in membranes of cardiomyocytes.
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: fatty acid variations
time frame: at J-21
measure: postoperative arrhythmias (atrial fibrillation)
time frame: at J-21, J0, J7 and J30
measure: postoperative inflammatory syndrome
time frame: at J-21, J0, J7 and J30
arm group label: Omega 3 supplemented patients
arm group type: Experimental
description: To show the existence of a atrial cardiomyocytes membranes modification in omega-3 supplemented patients with coronary atherosclerosis
arm group label: Control group
arm group type: No Intervention
intervention type: Dietary Supplement
intervention name: Omega 3
description: To show the existence of a atrial cardiomyocytes membranes modification in omega-3 supplemented patients with coronary atherosclerosis
arm group label: Omega 3 supplemented patients
criteria: 
gender: Male
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Kasra AZARNOUSH
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
last name: Patrick LACARIN
phone: 04 73 75 11 95
email: placarin@chu-clermontferrand.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Atherosclerosis
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia