NCT03871647

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
256

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

March 11, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 12, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2021

Completed
Last Updated

November 9, 2021

Status Verified

November 1, 2021

Enrollment Period

1.7 years

First QC Date

March 11, 2019

Last Update Submit

November 6, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Occurrence of Atrial fibrillation

    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

Study Arms (2)

POAF group

Patients who will experience AF at any time during the first six days after the operation.

Drug: Beta blocker

Non POAF group

Patients with a sinus rhythm during the first six days after the operation.

Drug: Beta blocker

Interventions

perioperative beta blockers

Non POAF groupPOAF group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Egyptian patients undergoing Coronary Artery Bypass grafting Surgery

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Cardiovascular & Thoracic Academy - Ain Shams University.

Cairo, Egypt

Location

Related Publications (1)

  • El Gindy DMK, Solayman MH, Khorshid R, Schaalan MF, El Wakeel LM. Effect of Clinical and Genetic Factors on the Development of Postoperative Atrial Fibrillation After Coronary Artery Bypass Grafting (CABG) in Egyptian Patients Receiving Beta-Blockers. Cardiovasc Drugs Ther. 2024 Feb;38(1):99-108. doi: 10.1007/s10557-022-07380-6. Epub 2022 Sep 15.

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Adrenergic beta-Antagonists

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adrenergic AntagonistsAdrenergic AgentsNeurotransmitter AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesPhysiological Effects of Drugs

Study Officials

  • Dina M El Gindy, MSC

    Misr Ineternational University

    PRINCIPAL INVESTIGATOR
  • Lamiaa M ElWakeel, PhD

    Ain Shams University

    STUDY CHAIR
  • 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

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of Clinical Pharmacy

Study Record Dates

First Submitted

March 11, 2019

First Posted

March 12, 2019

Study Start

March 11, 2019

Primary Completion

December 7, 2020

Study Completion

March 7, 2021

Last Updated

November 9, 2021

Record last verified: 2021-11

Locations