Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2026-02-24 @ 5:02 PM
Study NCT ID:
NCT02349269
Status:
COMPLETED
Last Update Posted:
2015-01-28
First Post:
2014-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Atrial Fibrillation and Long-term Survival
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003643', 'term': 'Death'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 519}, 'targetDuration': '105 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-23', 'studyFirstSubmitDate': '2014-12-01', 'studyFirstSubmitQcDate': '2015-01-23', 'lastUpdatePostDateStruct': {'date': '2015-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cardiovascular and all-cause death', 'timeFrame': '1-105 month'}, {'measure': 'stroke', 'timeFrame': '1-105 month'}, {'measure': 'late atrial fibrillation', 'timeFrame': '1-105 month'}, {'measure': 'myocardial infarction', 'timeFrame': '1-105 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Atrial fibrillation', 'CABG', 'Stroke'], 'conditions': ['Death', 'Stroke', 'Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'The aim of the investigators trial was to evaluate association between new onset postoperative atrial fibrillation (POAF) and late cardiovascular morbidity and mortality.', 'detailedDescription': 'The material of this retrospective study consist patients without preoperative history of atrial fibrillation, participated in three different randomized controlled trials previously . A total of 519 consecutive patients underwent coronary artery bypass surgery, aortic valve replacement or combined aortic valve with coronary bypass surgery in Kuopio University Hospital from 2004 to 2008. Patients with previous episodes of atrial fibrillation (AF) or flutter and also patients with mitral valve surgery were excluded. All patients had continuous postoperative ECG monitoring for at least 48 hours. AF episodes lasting longer than 5 minutes were registered. Thereafter 12 lead ECG was recorded daily and in case of symptoms of rhythm disturbances.\n\nMedical records were reviewed during 2012 using standardized data collection protocol. Statistics Finland database was used for mortality data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients without preoperative history of atrial fibrillation, participated in three different randomized controlled trials previously', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* previously cardiac operation, CABG or AVR\n\nExclusion Criteria:\n\n* Previous Atrial fibrillation'}, 'identificationModule': {'nctId': 'NCT02349269', 'acronym': 'POAF', 'briefTitle': 'Postoperative Atrial Fibrillation and Long-term Survival', 'organization': {'class': 'OTHER', 'fullName': 'Kuopio University Hospital'}, 'officialTitle': 'Postoperative Atrial Fibrillation After Cardiac Surgery is Not an Independent Risk Factor for Long-term Cardiovascular Morbidity and Mortality in Anticoagulated Patients', 'orgStudyIdInfo': {'id': 'samuelm1'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kuopio University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Eastern Finland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}