[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604172":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":37,"studyPopulation":38,"armGroups":39,"interventions":49,"overallOfficials":55,"centralContacts":33,"locations":60,"responsibleParty":85,"collaborators":33,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":33,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":33,"studyType":100,"phases":33,"briefSummary":101,"conditions":102,"keywords":105,"overallStatus":63,"whyStopped":33,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"China National Center for Cardiovascular Diseases","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":33},[9],{"measure":10,"description":11,"timeFrame":12},"A composite of all-cause death, stroke, systemic embolism, myocardial infarction, unplanned cardiac rehospitalization, or post-discharge atrial fibrillation.","The primary outcome was the time to first occurrence of a composite of all-cause death, stroke, systemic embolism, myocardial infarction, unplanned cardiac rehospitalization, or post-discharge atrial fibrillation from randomization through 3 years after surgery.","3 year after the surgery",[14,18,20,24,27,30],{"measure":15,"description":16,"timeFrame":17},"the individual components of the primary composite outcome","the individual components of all-cause death, stroke, systemic embolism, myocardial infarction, unplanned cardiac rehospitalization, or post-discharge atrial fibrillation","within 3 year after surgery",{"measure":19,"description":19,"timeFrame":17},"unplanned all-cause rehospitalization",{"measure":21,"description":22,"timeFrame":23},"premature atrial contraction and premature ventricular contraction burdens","premature atrial contraction and premature ventricular contraction burdens recorded by the 3-day continuous ECG monitoring","3 year after surgery",{"measure":25,"description":26,"timeFrame":12},"Holter-derived parameter, mean heart rate","mean heart rate derived from the 3-day ECG monitoring",{"measure":28,"description":29,"timeFrame":12},"Holter-derived parameter, HRV","HRV derived from the 3-day ECG monitoring",{"measure":31,"description":32,"timeFrame":12},"Assessment of quality of life","Assessed by EQ-5D-5L (EuroQol 5-Dimensions 5-Levels questionnaire, higher score means better outcome) and AFEQT (Atrial-Fibrillation-Effect-on-Quality-of-life-Questionnaire, higher score means better outcome).",null,{"allocation":33,"interventionModel":33,"interventionModelDescription":33,"primaryPurpose":33,"observationalModel":35,"timePerspective":36,"maskingInfo":33},"COHORT","PROSPECTIVE","This study aimed to observe clinical outcomes 3 years after surgery in patients enrolled in pCAD-POAF trial.\n\nAfter completing the pCAD-POAF trial, investigators would not make any other interventions on enrolled patients. At the 3 year follow-up visit, all subjects will undergo regular laboratory test , electrocardiogram (ECG), ultrasound cardiography (UCG). Besides, coronary computed tomographic angiography(CCTA) will be performed depending on their own willingness. In the meantime, all subjects will be continuously monitored by wearing specific device for the detection of arrhythmias. Data collection will also include the use of medications, medical tests, any documented arrhythmias and the occurrence of clinical events within the 3 years.\n\nIn conclusion, this is a extensive follow-up of previous RCT and a non-interventional, observational study.","The population enrolled previously in pCAD-POAF trial.",[40,45],{"label":41,"type":33,"description":42,"interventionNames":43},"Intervention group","This group underwent partial cardiac denervation procedure as well as CABG in the pCAD-POAF trial. However, no other intervention was performed after completing the pCAD-POAF trial.",[44],"Other: no other intervention",{"label":46,"type":33,"description":47,"interventionNames":48},"Control group","This group only underwent CABG in the pCAD-POAF trial. Likewise, no other intervention was performed after completing the pCAD-POAF trial",[44],[50],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":33},"OTHER","no other intervention","This is a observational study.",[46,41],[56],{"name":57,"affiliation":58,"role":59},"Wei Feng, MD","Chinese Academy of Medical Sciences, Fuwai Hospital","PRINCIPAL_INVESTIGATOR",[61],{"facility":62,"status":63,"city":64,"state":33,"zip":33,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Fuwai Hospital, CAMS & PUMC","RECRUITING","Beijing","China","CN",{"type":68,"coordinates":69},"Point",[70,71],116.39723,39.9075,{"lat":71,"lon":70},[74,78,81,82],{"name":57,"role":75,"phone":76,"phoneExt":33,"email":77},"CONTACT","010-88322265","fengwei@fuwai.com",{"name":79,"role":75,"phone":76,"phoneExt":33,"email":80},"Ziang Yang, MD","yzang47@163.com",{"name":57,"role":59,"phone":33,"phoneExt":33,"email":33},{"name":83,"role":84,"phone":33,"phoneExt":33,"email":33},"Zhan Hu, MD","SUB_INVESTIGATOR",{"type":86,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100604172","pcad-poaf-3-year-follow-up-100604172",false,"NCT07146061","pCAD-POAF 3 Year Follow-up","Partial Cardiac Denervation to Prevent POAF After CABG: 3 Year Follow-up of pCAD-POAF Randomized Trial","Inclusion Criteria:\n\n* This study will include the subjects who enrolled in pCAD-POAF trial\n\nExclusion Criteria:\n\n* This study will include the subjects who enrolled in pCAD-POAF trial","ALL","18 Years","85 Years",{"count":98,"type":99},430,"ESTIMATED","OBSERVATIONAL","This study will include the subjects who enrolled in pCAD-POAF trial (NCT05009914) to observe clinical outcomes 3 years after surgery.\n\nThe primary outcome is the time to first occurrence of a composite of all-cause death, stroke, systemic embolism, myocardial infarction, unplanned cardiac rehospitalization, or post-discharge atrial fibrillation from randomization through 3 years after surgery.\n\nThe secondary outcomes are：the individual components of the primary composite outcome; unplanned all-cause rehospitalization; arrhythmias other than atrial fibrillation; premature atrial contraction and premature ventricular contraction burdens; heart rate variability parameters; quality-of-life scores; and other Holter-derived parameters.",[103,104],"Coronary Artery Disease","Atrial Fibrillation",[106,107],"coronary artery disease","atrial fibrillation","2026-09-27",{"date":110,"type":111},"2026-10-01","ACTUAL",{"date":113,"type":111},"2025-08-15",{"date":115,"type":99},"2027-01",{"name":5,"class":6},1]