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
About this trial
This is an interventional screening trial for Coronary Artery Disease Left Main
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
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
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
Learn more about this trial
Antegrade and Retrograde Versurs Antegrade Cardioplegia in Complex Coronary Artery Bypass Surgeries
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