Arrhythmia in on Pump vs. Off Pump Coronary Artery Bypass Grafting

September 16, 2019 updated by: Mohamed Emad Kamel, Assiut University
The aim of this research is to know the incidence of arrhythmias in on vs. off pump CABG and to know their relations to the patient's morbidity and mortality, hospital stay and hospital costs.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

On pump vs. off pump CABG has been a topic of debate for many years regarding the benefits and the risks of each technique .Off pump CABG began 30 years ago. Its promotion was based on its potential benefits over some of the limitation of traditional on pump CABG. It avoids the trauma of cardiopulmonary bypass (CPB) and minimizing aortic manipulation and reducing length of hospital stay and morbidity.

There is a criticism regarding completence of revascularization in off pump vs. on pump CABG, this is no longer valid in the current era as technology to safely perform multi vessel off pump has improved tremendously over the past decade.

One of the debates between these two techniques was the incidence of arrhythmias in and after the operation and its relation to morbidity and mortality at the operation and hospital stay after the operation.

As known atrial fibrillation (AF) is still the most common arrhythmia that occur after CABG and although in some studies it has been considered a benign and self-limiting complication, some suggest serious morbidity and mortality from this complication, it is said that it affects more than 40% of patients underwent CABG. Atrial fibrillation (AF) may lead to thromboembolic complications, additional pharmacotherapy, longer hospital stay, increase cost, anxiety and stroke.

Most AF post CABG are found in the second to third post-operative day. SO, on this study the investigators focus one the incidence of arrhythmias, especially AF in those two techniques and their relations to patients' morbidity and mortality.

Study Type

Observational

Enrollment (Anticipated)

50

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

  • Name: Mohamed Kamel, resident doctor
  • Phone Number: 01149625752\01063067860
  • Email: memad_505@yahoo.com

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

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients under going coronary artery bypass grafting from ischemic heart disease

Description

Inclusion Criteria:

  • All patients subjected to CABG

Exclusion Criteria:

  • Associated valvular heart disease
  • Emergency cases
  • Previous AF

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
on pump CABG
patients under going CABG with cardiopulmonary bypass machine
Device: cardio pulmonary bypass machine
cardio pulmonary bypass machine is a machine that work to compensate for the function of the heart and the lungs in the operation
off pump CABG
patients under going CABG without cardiopulmonary bypass machine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence of arrhythmias in on pump vs. off pump coronary artery bypass grafting
Time Frame: the number of episodes of arrhythmia s in one week after the operation
the frequency of arrhythmia s (in number of episodes) using a12-leads continuous electrocardiogram(ECG) in each type of the two operations.the number of patients that experience those arrhythmia s (in percentage) from the total number of patients that go for those two operations.
the number of episodes of arrhythmia s in one week after the operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
decrease morbidity, mortality, hospital stay and hospital cost
Time Frame: baseline
  1. To know the relation of the arrythmias in the number of days that the patient stays after the operation.
  2. To know the relation of the arrhythmias as a cause to the mortality of these patients.(number of patients die after the operation from the total deaths from these two operations).
  3. To know the the relation of the arrhythmias in these two operations to their patients morbidity.
baseline

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Chair: Samy Othman, prof.dr, Assiut University
  • Study Chair: Ahmed Taha, lecturer, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 1, 2021

Primary Completion (Anticipated)

May 1, 2022

Study Completion (Anticipated)

July 1, 2022

Study Registration Dates

First Submitted

September 6, 2019

First Submitted That Met QC Criteria

September 16, 2019

First Posted (Actual)

September 18, 2019

Study Record Updates

Last Update Posted (Actual)

September 18, 2019

Last Update Submitted That Met QC Criteria

September 16, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Arrhythmia in CABG

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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