Coronary Artery DiseaseCODA-AFNCT05888168
Predictors of Postoperative Atrial Fibrillation After CABG
An observational study of Coronary Artery Disease and Atrial Fibrillation New Onset, run by Kun Hua at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Atrial Fibrillation New Onset
- What is being tested?
- CABG
- Type of treatment
- Surgery or procedure
- How many people
- 15,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adults aged 18 years or older.
- Patients who underwent CABG.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- CABG
- Keywords
- coronary artery bypass grafting, postoperative atrial fibrillation
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CABGProcedure or surgery
All participants in the study will undergo the standard procedure of CABG. Continuous electrocardiogram monitoring and electrocardiography were used to identify the cardiac rhythm.
| Study group | Role | What they receive |
|---|---|---|
| POAF | This group will consist of patients who have developed postoperative atrillary fibrillation (POAF) after undergoing coronary artery bypass grafting (CABG). Receives: 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). Receives: Procedure: CABG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of POAF
This will be determined based on electrocardiograms (ECG) and/or relevant medical records, within 30 days post-CABG.
Measured: During hospital stay, up to 30 days
Secondary outcomes (4)
Hospital length of stay
Measured: During hospital stay, up to 30 days
ICU admission time
Measured: During hospital stay, up to 30 days
Number of participants with Stroke
Measured: During hospital stay, up to 30 days
Mortality
Measured: During hospital stay, up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start1 Jan 2018
- Primary completion15 Dec 2023 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kun Hua
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kun Hua, Beijing Anzhen Hospital
- Investigators
- Kun Hua, MD, Study chair, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05888168
- Sponsor's protocol ID
- 2023065X
- Acronym
- CODA-AF
- Status last verified
- Jun 2023
- First submitted
- 21 May 2023
- Last updated
- 5 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhou X, Pan Y, Hua K, Yang X. Impact of Sodium-Glucose Cotransporter 2 Inhibitors on Acute Kidney Injury Post Off-Pump Coronary Artery Bypass Grafting: A Retrospective Cohort Study and Meta-Analysis. Rev Cardiovasc Med. 2026 Jan 21;27(1):39400. doi: 10.31083/RCM39400. eCollection 2026 Jan.
PubMed 41659092
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Observational Study on the Determinants of Postoperative Atrial Fibrillation in Patients Undergoing Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT05888168
- Acronym / sponsor ID
- CODA-AF / 2023065X
- Keywords
- coronary artery bypass grafting, postoperative atrial fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Kun HuaUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POAF | – | Procedure: CABGThis group will consist of patients who have developed postoperative atrillary fibrillation (POAF) after undergoing coronary artery bypass grafting (CABG). |
| Non-POAF | – | Procedure: CABGThis group will consist of patients who have not developed postoperative atrillary fibrillation (POAF) after undergoing coronary artery bypass grafting (CABG). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Adults aged 18 years or older.
- Patients who underwent CABG.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CABGAll participants in the study will undergo the standard procedure of CABG. Continuous electrocardiogram monitoring and electrocardiography were used to identify the cardiac rhythm. | Procedure or surgery | Non-POAF, POAF |
Primary outcome
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.
4 secondary outcomes
Hospital length of stay
Time frame: During hospital stay, up to 30 days
ICU admission time
Time frame: During hospital stay, up to 30 days
Number of participants with Stroke
Time frame: During hospital stay, up to 30 days
Mortality
Time frame: During hospital stay, up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Derived from this study: PubMed 41659092Zhou X, Pan Y, Hua K, Yang X. Impact of Sodium-Glucose Cotransporter 2 Inhibitors on Acute Kidney Injury Post Off-Pump Coronary Artery Bypass Grafting: A Retrospective Cohort Study and Meta-Analysis. Rev Cardiovasc Med. 2026 Jan 21;27(1):39400. doi: 10.31083/RCM39400. eCollection 2026 Jan.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kun Hua, MD study chair
Beijing Anzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Atrial Fibrillation New Onset, run by Kun Hua at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of POAF (time frame: During hospital stay, up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05888168, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.