Predictors of Postoperative Atrial Fibrillation After Coronary Artery Bypass Grafting: A Prospective Cohort Study

May 26, 2020 updated by: Hanaa Mohamed Abdallah ElGendy MD, Ain Shams University
There are a wide range of significant epidemiological, clinical, and operative predictors for the development of post-CABG AF including older age, female gender, large LA diameter, higher CHA2DS2-VASc score, valve replacement and postoperative inotropic support. Nevertheless, further large-scale studies are still needed to confirm our findings

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

We included patients undergoing isolated CABG or CABG with (Aortic and / or Mitral) valve replacement with an age group between 18 and 70 years old.

Patients diagnosed preoperatively with AF or have history of AF, patients with history of existing pre-operative rhythm other than normal sinus rhythm (NSR), patients with impaired systolic function (Ejection fraction (EF) < 30%), patients with end stage renal disease (ESRD) on hemodialysis and patients who refused to participate in the study were excluded from the study.

Sample Size and Sampling: Using PASS program, setting alpha error at 5% and power 80%. Results from previous study Ducceschi et al. (6) showed that left atrial (LA) diameter was an independent factor affecting AF post CABG. Based on this, the needed sample was 123 cases undergoing CABG, including at least 24 patients with dilated LA.

All individuals were monitored for AF during the postoperative ICU stay with continuous ECG (5-leads) monitor, daily 12-lead ECG recording to confirm an episode of AF. AF was considered if P wave was absent before the QRS complex together with irregular ventricular rhythm on the rhythm strips.

Only AF episodes lasting > 5 minutes were counted. In the present study, the following data, as potential predictors of POAF, was collected from every eligible participant; age, sex, smoking and left atrial (LA) diameter based on formal preoperative Trans-thoracic Echocardiography. Serum potassium (K+) level was routinely measured postoperatively on ICU admission and every 2 hours and on demand (if arrhythmia occurs or suspected abnormal potassium level). It was recorded for statistical analysis on admission and every 12 hours and on demand until the patient was discharged.

Serum Magnesium (Mg++) level was measured routinely measured postoperatively on ICU admission and every 24 hours and on demand (if arrhythmia occurs or suspected abnormal magnesium level). It was recorded for statistical study on admission and every 24 hours and on demand until the patient was discharged.

Other parameters such as valve replacement (Aortic and/or Mitral) during the same operative setting, CHA2DS2-VASc score (Congestive heart failure, Hypertension [blood pressure >140/90 mm Hg or treated hypertension on medication], Age ≥75 years, Diabetes mellitus, prior Stroke or transient ischemic attack or thromboembolism, vascular disease, Age 65 to 74 years, Sex category [female sex] ), and post-operative inotropic support usage were recorded.

Study Type

Observational

Enrollment (Actual)

123

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

    • Ain Shams University Specialized Hospital
      • Cairo, Ain Shams University Specialized Hospital, Egypt
        • Hanaa El Gendy

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 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing isolated CABG or CABG with (Aortic and / or Mitral) valve replacement with an age group between 18 and 70 years old.

Description

Inclusion Criteria:

  • Patients undergoing isolated CABG
  • Patients undergoing CABG with (Aortic and / or Mitral) valve replacement
  • age group between 18 and 70 years old.

Exclusion Criteria:

  • Patients diagnosed preoperatively with AF or have history of AF
  • Patients with history of existing pre-operative rhythm other than normal sinus rhythm (NSR)
  • Patients with impaired systolic function (Ejection fraction (EF) < 30%)
  • Patients with end stage renal disease (ESRD) on hemodialysis
  • Patients who refused to participate in the study

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
Observational study
Non POAF
Observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of POAF
Time Frame: 6 months
Incidence of POAF 72hours postoperative
6 months

Collaborators and Investigators

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

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)

May 15, 2018

Primary Completion (ACTUAL)

March 18, 2019

Study Completion (ACTUAL)

May 23, 2019

Study Registration Dates

First Submitted

December 7, 2019

First Submitted That Met QC Criteria

December 9, 2019

First Posted (ACTUAL)

December 10, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 27, 2020

Last Update Submitted That Met QC Criteria

May 26, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • El-Manial Hospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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