<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/NCT04439162</url>
  </required_header>
  <id_info>
    <org_study_id>coronary artery bypass surgery</org_study_id>
    <nct_id>NCT04439162</nct_id>
  </id_info>
  <brief_title>Antegrade and Retrograde Versurs Antegrade Cardioplegia in Complex Coronary Artery Bypass Surgeries</brief_title>
  <official_title>Results of Combined Antegrade and Retrograde Versurs Antegrade Cardioplegia in Complex Coronary Artery Bypass Surgeries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      During coronary artery bypass surgery, myocardial protection, especially of the right&#xD;
      ventricle, may be inadequate in the presence of severe coronary lesions that obstruct the&#xD;
      antegrade delivery of cold cardioplegia&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Asymetric myocardial cooling has been reported to yield postoperative right ventricular&#xD;
      dysfunction, which may contribute to postoperative morbidity and mortality. Retrograde&#xD;
      coronary sinus perfusion was introduced in 1956 to facilitate surgery involving the aortic&#xD;
      valve. This technique was introduced as a means of myocardial protection for coronary artery&#xD;
      bypass surgery in 1967 and has recently received renewed interest. An innovative method of&#xD;
      delivering retrograde cardioplegia through the right atrium was recently developed by Fabiani&#xD;
      and associates. This technique has obviated the need to directly cannulate the coronary sinus&#xD;
      and thus has eliminated concerns regarding coronary sinus rupture due to cannulation, and&#xD;
      concerns of inadequate right ventricular perfusion. In contrast to antegrade delivery,&#xD;
      retrograde delivery of cardioplegia through the right atrium is not subject to the problem of&#xD;
      limited distribution in the presence of coronary artery occlusive disease and thus allows&#xD;
      more uniform cooling of the left ventricle,so the study will compare the results of combined&#xD;
      antegrade and retrograde versurs antegrade cardioplegia in complex coronary artery bypass&#xD;
      surgeries&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">April 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>RCT</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>myocardial function</measure>
    <time_frame>two years</time_frame>
    <description>compare simultaneous antegrade-retrograde cardioplegia with antegrade cardioplegia in coronary artery surgeries in preservation of myocardial function by using transthoracic echocardiography examination postoperatively</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Coronary Artery Disease Left Main</condition>
  <arm_group>
    <arm_group_label>group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>antegrade cardioplegia</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>retrograde cardioplegia protection</intervention_name>
    <description>antegrade-retrograde cardioplegia</description>
    <arm_group_label>group A</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18 and 60 years&#xD;
&#xD;
          -  LV ejection fraction between 30 and 50%&#xD;
&#xD;
          -  left main stem CAD&#xD;
&#xD;
          -  mitral or aortic valve disease associated with ischemic heart disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Double valve disease or other valve disease&#xD;
&#xD;
          -  mitral or aortic valve disease associated with congenital heart disease&#xD;
&#xD;
          -  patients subjected to prior heart surgery&#xD;
&#xD;
          -  emergency operation&#xD;
&#xD;
          -  poorly controlled diabetes mellitus&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Elhussein M abdelmottaleb, Ph.D</last_name>
    <phone>00201003873076</phone>
    <email>sahs_romeo90@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>ahmed m abdelmottaleb, lecturer</last_name>
    <phone>00201003873076</phone>
    <email>sahs_romeo90@hotmail.com</email>
  </overall_contact_backup>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>June 17, 2020</last_update_submitted>
  <last_update_submitted_qc>June 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>El hussein Mohamed Abdelmotaleb Abdelhafez</investigator_full_name>
    <investigator_title>associate lecteuer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</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/NCT04439162
org study id: coronary artery bypass surgery
nct id: NCT04439162
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
During coronary artery bypass surgery, myocardial protection, especially of the right
      ventricle, may be inadequate in the presence of severe coronary lesions that obstruct the
      antegrade delivery of cold cardioplegia
Asymetric myocardial cooling has been reported to yield postoperative right ventricular
      dysfunction, which may contribute to postoperative morbidity and mortality. Retrograde
      coronary sinus perfusion was introduced in 1956 to facilitate surgery involving the aortic
      valve. This technique was introduced as a means of myocardial protection for coronary artery
      bypass surgery in 1967 and has recently received renewed interest. An innovative method of
      delivering retrograde cardioplegia through the right atrium was recently developed by Fabiani
      and associates. This technique has obviated the need to directly cannulate the coronary sinus
      and thus has eliminated concerns regarding coronary sinus rupture due to cannulation, and
      concerns of inadequate right ventricular perfusion. In contrast to antegrade delivery,
      retrograde delivery of cardioplegia through the right atrium is not subject to the problem of
      limited distribution in the presence of coronary artery occlusive disease and thus allows
      more uniform cooling of the left ventricle,so the study will compare the results of combined
      antegrade and retrograde versurs antegrade cardioplegia in complex coronary artery bypass
      surgeries
allocation: N/A
intervention model: Single Group Assignment
intervention model description: RCT
primary purpose: Screening
masking: None (Open Label)
measure: myocardial function
time frame: two years
description: compare simultaneous antegrade-retrograde cardioplegia with antegrade cardioplegia in coronary artery surgeries in preservation of myocardial function by using transthoracic echocardiography examination postoperatively
arm group label: group A
arm group type: Experimental
description: antegrade cardioplegia
intervention type: Procedure
intervention name: retrograde cardioplegia protection
description: antegrade-retrograde cardioplegia
arm group label: group A
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Elhussein M abdelmottaleb, Ph.D
phone: 00201003873076
email: sahs_romeo90@hotmail.com
last name: ahmed m abdelmottaleb, lecturer
phone: 00201003873076
email: sahs_romeo90@hotmail.com
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: El hussein Mohamed Abdelmotaleb Abdelhafez
investigator title: associate lecteuer
mesh term: Coronary Artery Disease