Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-26 @ 11:01 PM
Study NCT ID:
NCT05888168
Status:
UNKNOWN
Last Update Posted:
2023-06-05
First Post:
2023-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictors of Postoperative Atrial Fibrillation After CABG
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-01', 'studyFirstSubmitDate': '2023-05-21', 'studyFirstSubmitQcDate': '2023-06-01', 'lastUpdatePostDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of POAF', 'timeFrame': 'During hospital stay, up to 30 days', 'description': 'This will be determined based on electrocardiograms (ECG) and/or relevant medical records, within 30 days post-CABG.'}], 'secondaryOutcomes': [{'measure': 'Hospital length of stay', 'timeFrame': 'During hospital stay, up to 30 days'}, {'measure': 'ICU admission time', 'timeFrame': 'During hospital stay, up to 30 days'}, {'measure': 'Number of participants with Stroke', 'timeFrame': 'During hospital stay, up to 30 days'}, {'measure': 'Mortality', 'timeFrame': 'During hospital stay, up to 30 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['coronary artery bypass grafting', 'postoperative atrial fibrillation'], 'conditions': ['Coronary Artery Disease', 'Atrial Fibrillation New Onset']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Patients who underwent CABG.\n\nExclusion Criteria:\n\n* Patients with a history of preoperative atrial fibrillation or other significant arrhythmias.\n* Patients who underwent other concurrent cardiac procedures (e.g., valve surgery) in addition to CABG.\n* Patients who cannot provide informed consent or lack adequate follow-up information.'}, 'identificationModule': {'nctId': 'NCT05888168', 'acronym': 'CODA-AF', 'briefTitle': 'Predictors of Postoperative Atrial Fibrillation After CABG', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Anzhen Hospital'}, 'officialTitle': 'A Comprehensive Observational Study on the Determinants of Postoperative Atrial Fibrillation in Patients Undergoing Coronary Artery Bypass Grafting', 'orgStudyIdInfo': {'id': '2023065X'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'POAF', 'description': 'This group will consist of patients who have developed postoperative atrillary fibrillation (POAF) after undergoing coronary artery bypass grafting (CABG).', 'interventionNames': ['Procedure: CABG']}, {'label': 'Non-POAF', 'description': 'This group will consist of patients who have not developed postoperative atrillary fibrillation (POAF) after undergoing coronary artery bypass grafting (CABG).', 'interventionNames': ['Procedure: CABG']}], 'interventions': [{'name': 'CABG', 'type': 'PROCEDURE', 'description': 'All participants in the study will undergo the standard procedure of CABG. Continuous electrocardiogram monitoring and electrocardiography were used to identify the cardiac rhythm.', 'armGroupLabels': ['Non-POAF', 'POAF']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Anzhen Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Kun Hua, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Beijing Anzhen Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kun Hua', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Deputy Chief Surgeon', 'investigatorFullName': 'Kun Hua', 'investigatorAffiliation': 'Beijing Anzhen Hospital'}}}}