Predictors of Postoperative Atrial Fibrillation After CABG (CODA-AF)

June 1, 2023 updated by: Kun Hua

A Comprehensive Observational Study on the Determinants of Postoperative Atrial Fibrillation in Patients Undergoing Coronary Artery Bypass Grafting

This observational study aims to identify the determinants or predictors of postoperative atrial fibrillation (POAF) in patients who have undergone coronary artery bypass grafting (CABG). The study will compare two cohorts: patients who developed POAF and those who did not (non-POAF), with the aim of improving postoperative care, reducing complications, and refining patient risk stratification.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Demographics (age, sex, ethnicity), lifestyle factors (smoking, alcohol, physical activity), and medical history (diabetes, hypertension, prior heart diseases) will be recorded. Surgical procedure details (number of grafts, use of intraoperative devices), anesthesia, and medications administered. Levels of inflammatory markers, cardiac-specific markers, and other relevant biomarkers at baseline and postoperatively. Other complications besides POAF, hospital length of stay, ICU admission, readmission rate, and mortality will also be monitored.

Study Type

Observational

Enrollment (Estimated)

15000

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

  • China
      • Beijing, China
        • Beijing Anzhen Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The participants in this study are adult patients (18 years and older) who have undergone Coronary Artery Bypass Grafting (CABG). These individuals come from diverse demographic backgrounds and have a history of severe coronary heart disease, the condition that necessitated the CABG surgery.

Description

Inclusion Criteria:

  • Adults aged 18 years or older.
  • Patients who underwent CABG.

Exclusion Criteria:

  • Patients with a history of preoperative atrial fibrillation or other significant arrhythmias.
  • Patients who underwent other concurrent cardiac procedures (e.g., valve surgery) in addition to CABG.
  • Patients who cannot provide informed consent or lack adequate follow-up information.

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
This group will consist of patients who have developed postoperative atrillary fibrillation (POAF) after undergoing coronary artery bypass grafting (CABG).
Procedure: CABG
All participants in the study will undergo the standard procedure of CABG. Continuous electrocardiogram monitoring and electrocardiography were used to identify the cardiac rhythm.
Non-POAF
This group will consist of patients who have not developed postoperative atrillary fibrillation (POAF) after undergoing coronary artery bypass grafting (CABG).
Procedure: CABG
All participants in the study will undergo the standard procedure of CABG. Continuous electrocardiogram monitoring and electrocardiography were used to identify the cardiac rhythm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of POAF
Time Frame: During hospital stay, up to 30 days
This will be determined based on electrocardiograms (ECG) and/or relevant medical records, within 30 days post-CABG.
During hospital stay, up to 30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Hospital length of stay
Time Frame: During hospital stay, up to 30 days
During hospital stay, up to 30 days
ICU admission time
Time Frame: During hospital stay, up to 30 days
During hospital stay, up to 30 days
Number of participants with Stroke
Time Frame: During hospital stay, up to 30 days
During hospital stay, up to 30 days
Mortality
Time Frame: During hospital stay, up to 30 days
During hospital stay, up to 30 days

Collaborators and Investigators

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

Sponsor

Kun Hua

Investigators

  • Study Chair: Kun Hua, MD, Beijing Anzhen Hospital

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)

January 1, 2018

Primary Completion (Estimated)

December 15, 2023

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

May 21, 2023

First Submitted That Met QC Criteria

June 1, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Actual)

June 5, 2023

Last Update Submitted That Met QC Criteria

June 1, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023065X

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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