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

Coronary Artery Disease Left Main Clinical Trial

Official title:

Results of Combined Antegrade and Retrograde Versurs Antegrade Cardioplegia in Complex Coronary Artery Bypass Surgeries

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04439162
• Other study ID #: coronary artery bypass surgery
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: April 1, 2022

Study information

• Verified date: June 2020
• Source: Assiut University
• Contact: Elhussein M abdelmottaleb, Ph.D
• Phone: 00201003873076
• Email: sahs_romeo90[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: April 1, 2022
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Disease Left Main

Intervention

Procedure:
• retrograde cardioplegia protection
antegrade-retrograde cardioplegia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	two years