CODA-AF: Predictors of Postoperative Atrial Fibrillation After CABG

Sponsor
Kun Hua (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05888168
Collaborator
(none)
15,000
1
76
197.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: CABG

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 Design

Study Type:
Observational
Anticipated Enrollment :
15000 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
A Comprehensive Observational Study on the Determinants of Postoperative Atrial Fibrillation in Patients Undergoing Coronary Artery Bypass Grafting
Actual Study Start Date :
Jan 1, 2018
Anticipated Primary Completion Date :
Dec 15, 2023
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Incidence of POAF [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.

Secondary Outcome Measures

  1. Hospital length of stay [During hospital stay, up to 30 days]

  2. ICU admission time [During hospital stay, up to 30 days]

  3. Number of participants with Stroke [During hospital stay, up to 30 days]

  4. Mortality [During hospital stay, up to 30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Anzhen Hospital Beijing China

Sponsors and Collaborators

  • Kun Hua

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kun Hua, Deputy Chief Surgeon, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier:
NCT05888168
Other Study ID Numbers:
  • 2023065X
First Posted:
Jun 5, 2023
Last Update Posted:
Jun 5, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kun Hua, Deputy Chief Surgeon, Beijing Anzhen Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 5, 2023