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Antegrade and Retrograde Versurs Antegrade Cardioplegia in Complex Coronary Artery Bypass Surgeries

Primary Purpose

Coronary Artery Disease Left Main

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
retrograde cardioplegia protection
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Coronary Artery Disease Left Main

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 18 and 60 years
  • LV ejection fraction between 30 and 50%
  • left main stem CAD
  • mitral or aortic valve disease associated with ischemic heart disease

Exclusion Criteria:

  • Double valve disease or other valve disease
  • mitral or aortic valve disease associated with congenital heart disease
  • patients subjected to prior heart surgery
  • emergency operation
  • poorly controlled diabetes mellitus

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    group A

    Arm Description

    antegrade cardioplegia

    Outcomes

    Primary Outcome Measures

    myocardial function
    compare simultaneous antegrade-retrograde cardioplegia with antegrade cardioplegia in coronary artery surgeries in preservation of myocardial function by using transthoracic echocardiography examination postoperatively

    Secondary Outcome Measures

    Full Information

    First Posted
    June 11, 2020
    Last Updated
    June 17, 2020
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04439162
    Brief Title
    Antegrade and Retrograde Versurs Antegrade Cardioplegia in Complex Coronary Artery Bypass Surgeries
    Official Title
    Results of Combined Antegrade and Retrograde Versurs Antegrade Cardioplegia in Complex Coronary Artery Bypass Surgeries
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 1, 2020 (Anticipated)
    Primary Completion Date
    June 1, 2021 (Anticipated)
    Study Completion Date
    April 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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
    Detailed Description
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Artery Disease Left Main

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    RCT
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    group A
    Arm Type
    Experimental
    Arm Description
    antegrade cardioplegia
    Intervention Type
    Procedure
    Intervention Name(s)
    retrograde cardioplegia protection
    Intervention Description
    antegrade-retrograde cardioplegia
    Primary Outcome Measure Information:
    Title
    myocardial function
    Description
    compare simultaneous antegrade-retrograde cardioplegia with antegrade cardioplegia in coronary artery surgeries in preservation of myocardial function by using transthoracic echocardiography examination postoperatively
    Time Frame
    two years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age between 18 and 60 years LV ejection fraction between 30 and 50% left main stem CAD mitral or aortic valve disease associated with ischemic heart disease Exclusion Criteria: Double valve disease or other valve disease mitral or aortic valve disease associated with congenital heart disease patients subjected to prior heart surgery emergency operation poorly controlled diabetes mellitus
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Elhussein M abdelmottaleb, Ph.D
    Phone
    00201003873076
    Email
    sahs_romeo90@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    ahmed m abdelmottaleb, lecturer
    Phone
    00201003873076
    Email
    sahs_romeo90@hotmail.com

    12. IPD Sharing Statement

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    Antegrade and Retrograde Versurs Antegrade Cardioplegia in Complex Coronary Artery Bypass Surgeries

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