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

June 17, 2020 updated by: El hussein Mohamed Abdelmotaleb Abdelhafez, Assiut University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: group A
antegrade cardioplegia
Procedure: retrograde cardioplegia protection
antegrade-retrograde cardioplegia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
myocardial function
Time Frame: two years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 1, 2020

Primary Completion (ANTICIPATED)

June 1, 2021

Study Completion (ANTICIPATED)

April 1, 2022

Study Registration Dates

First Submitted

June 11, 2020

First Submitted That Met QC Criteria

June 17, 2020

First Posted (ACTUAL)

June 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 19, 2020

Last Update Submitted That Met QC Criteria

June 17, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • coronary artery bypass surgery

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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