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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05888168
Other study ID # 2023065X
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date May 1, 2024

Study information

Verified date June 2023
Source Beijing Anzhen Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 15000
Est. completion date May 1, 2024
Est. primary completion date December 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
China Beijing Anzhen Hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Kun Hua

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Hospital length of stay During hospital stay, up to 30 days
Secondary ICU admission time During hospital stay, up to 30 days
Secondary Number of participants with Stroke During hospital stay, up to 30 days
Secondary Mortality During hospital stay, up to 30 days
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