Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2025-12-27 @ 10:18 PM
Study NCT ID:
NCT07146061
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-28
First Post:
2025-08-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
pCAD-POAF 3 Year Follow-up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}], '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'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 430}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2025-08-14', 'studyFirstSubmitQcDate': '2025-08-27', 'lastUpdatePostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AF burden', 'timeFrame': '3 year after the surgery', 'description': 'the AF burden during 3-day continuous ECG monitoring among 2 groups at the 3 year follow-up.'}], 'secondaryOutcomes': [{'measure': 'Freedom of AF without the use of antiarrhymic medications or interventions', 'timeFrame': 'within 3 year after surgery', 'description': 'Freedom of AF without the use of antiarrhymic medications or interventions'}, {'measure': 'The occurence of MACCE', 'timeFrame': 'within 3 year after surgery', 'description': 'including all-cause mortality, stroke, myocardial infarction, systemic arterial embolism, revascularization, and rehospitalization for heart failure'}, {'measure': 'AF incidence in 3 years and recorded by continuous ECG monitoring', 'timeFrame': '3 year after the surgery', 'description': 'AF incidence in 3 years and recorded by continuous ECG monitoring'}, {'measure': 'Post-operative antiarrhythmic interventions and occurrence of arrhythmias other than AF', 'timeFrame': 'within 3 year after surgery', 'description': 'Post-operative antiarrhythmic interventions and occurrence of arrhythmias other than AF'}, {'measure': 'The mean, maximum, and minimum heart rate and HRV', 'timeFrame': '3 year after the surgery', 'description': 'recorded by Holter monitoring at the 3 year follow-up visit'}, {'measure': 'Assessment of quality of life', 'timeFrame': '3 year after the surgery', 'description': '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).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['coronary artery disease', 'atrial fibrillation'], 'conditions': ['Coronary Artery Disease', 'Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': '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 AF burden during 3-day continuous ECG monitoring among 2 groups in pCAD-POAF trial 3 years after surgery.\n\nThe secondary outcomes areļ¼1. Freedom of AF without the use of antiarrhymic medications or interventions ; 2. The occurence of MACCE (including all-cause mortality, stroke, myocardial infarction, systemic arterial embolism, revascularization, and rehospitalization for heart failure); 3. AF incidence in 3 years and recorded by continuous ECG monitoring; 4. Post-operative antiarrhythmic interventions and occurrence of arrhythmias other than AF; 5. The mean, maximum, and minimum heart rate recorded by Holter monitoring, as well as heart rate variability (HRV); 6. Quality of life assessment, such as EQ-5D-5L and AFEQT.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The population enrolled previously in pCAD-POAF trial.', 'healthyVolunteers': False, 'eligibilityCriteria': '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'}, 'identificationModule': {'nctId': 'NCT07146061', 'briefTitle': 'pCAD-POAF 3 Year Follow-up', 'organization': {'class': 'OTHER_GOV', 'fullName': 'China National Center for Cardiovascular Diseases'}, 'officialTitle': 'Partial Cardiac Denervation to Prevent POAF After CABG: 3 Year Follow-up of pCAD-POAF Randomized Trial', 'orgStudyIdInfo': {'id': '2025-GSP-GG-12'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intervention group', 'description': '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.', 'interventionNames': ['Other: no other intervention']}, {'label': 'Control group', 'description': 'This group only underwent CABG in the pCAD-POAF trial. Likewise, no other intervention was performed after completing the pCAD-POAF trial', 'interventionNames': ['Other: no other intervention']}], 'interventions': [{'name': 'no other intervention', 'type': 'OTHER', 'description': 'This is a observational study.', 'armGroupLabels': ['Control group', 'Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Fuwai Hospital, CAMS & PUMC', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Wei Feng, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China National Center for Cardiovascular Diseases', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}