Effect of Genetic Polymorphism on the Occurrence of Post-Operative Atrial Fibrillation After CABG

November 6, 2021 updated by: Dina Mohamed Kamal El gindy, Ain Shams University

Effect of Genetic Polymorphism on the Occurrence of Post-Operative Atrial Fibrillation After Coronory Artery Bypass Grafting (CABG) Surgery in Egyptian Patients Receiving Beta Blockers

Postoperative Atrial Fibrillation (POAF) is one of the most common complications following coronary artery bypass grafting (CABG) occurring to 20% - 40% of patients. It is associated with prolonged hospitalization, increased hospital costs, increased complications and mortality rate.

Despite the use of Beta Blockers, approximately 20% of patients develop atrial fibrillation following CABG surgery, suggesting a role for polymorphism in the genes The aim of the present study is to determine the minor allele frequency of some of the genes that affect the beta blockers' response and to determine the association between polymorphism in these genes and the occurrence of postoperative atrial fibrillation after coronary artery bypass grafting in Egyptian patients receiving perioperative beta blockers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

256

Contacts and Locations

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

Study Locations

  • Egypt
      • Cairo, Egypt
        • The Cardiovascular & Thoracic Academy - Ain Shams University.

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 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Egyptian patients undergoing Coronary Artery Bypass grafting Surgery

Description

Inclusion Criteria:

  1. Age above 18 years.
  2. Candidates for CABG surgery without a concurrent valve surgery.
  3. Patients receiving perioperative beta blockers before new onset of postoperative AF.

Exclusion Criteria:

  1. Patients who have either persistent or permanent AF, atrial flutter or atrial tachycardia on ECG obtained on the day of the operation.
  2. Serum creatinine >2 mg/dL before the surgery.
  3. Uncontrolled thyroid disease.
  4. Recent treatment with amiodarone before the occurrence of POAF

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
POAF group
Patients who will experience AF at any time during the first six days after the operation.
Drug: Beta blocker
perioperative beta blockers
Non POAF group
Patients with a sinus rhythm during the first six days after the operation.
Drug: Beta blocker
perioperative beta blockers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of Atrial fibrillation
Time Frame: within 6 days after the operation
Atrial fibrillation based on postoperative electrocardiogram. AF diagnostic criteria will include absence of discrete P waves, the RR intervals follow unrepetitive form and the ranges of ventricular rate usually between 90 and 170 beats/min.
within 6 days after the operation

Collaborators and Investigators

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

Sponsor

Ain Shams University

Collaborators

Misr International University

Investigators

  • Principal Investigator: Dina M El Gindy, MSC, Misr Ineternational University
  • Study Chair: Lamiaa M ElWakeel, PhD, Ain Shams University
  • Study Director: Mona F Schaalan, PhD, Misr International University
  • Study Director: Ramy MR Khorshid, Md, PhD, Ain Shams Uiversity
  • Study Director: Mohamed H Solayman, PhD, Ain sham 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 (ACTUAL)

March 11, 2019

Primary Completion (ACTUAL)

December 7, 2020

Study Completion (ACTUAL)

March 7, 2021

Study Registration Dates

First Submitted

March 11, 2019

First Submitted That Met QC Criteria

March 11, 2019

First Posted (ACTUAL)

March 12, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 9, 2021

Last Update Submitted That Met QC Criteria

November 6, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PhD 53

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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