NCT05888168

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2018

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 5, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

June 5, 2023

Status Verified

June 1, 2023

Enrollment Period

6 years

First QC Date

May 21, 2023

Last Update Submit

June 1, 2023

Conditions

Keywords

coronary artery bypass graftingpostoperative atrial fibrillation

Outcome Measures

Primary Outcomes (1)

  • Incidence of POAF

    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 Outcomes (4)

  • Hospital length of stay

    During hospital stay, up to 30 days

  • ICU admission time

    During hospital stay, up to 30 days

  • Number of participants with Stroke

    During hospital stay, up to 30 days

  • Mortality

    During hospital stay, up to 30 days

Study Arms (2)

POAF

This group will consist of patients who have developed postoperative atrillary fibrillation (POAF) after undergoing coronary artery bypass grafting (CABG).

Procedure: CABG

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

Interventions

CABGPROCEDURE

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-POAFPOAF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anzhen Hospital

Beijing, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Kun Hua, MD

    Beijing Anzhen Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Deputy Chief Surgeon

Study Record Dates

First Submitted

May 21, 2023

First Posted

June 5, 2023

Study Start

January 1, 2018

Primary Completion

December 15, 2023

Study Completion

May 1, 2024

Last Updated

June 5, 2023

Record last verified: 2023-06

Locations