Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-31 @ 4:32 PM
Study NCT ID:
NCT04001205
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2019-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atrial Fibrillation Burden and Long-term Risk of Thromboembolic Complications- the FinCV-4 Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020521', 'term': 'Stroke'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000095062', 'term': 'Anticoagulation Bridge'}], 'ancestors': [{'id': 'D000093142', 'term': 'Bridge Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-01-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2019-06-21', 'studyFirstSubmitQcDate': '2019-06-26', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death', 'timeFrame': 'From the first cardioversion through study completion, an average of 6 years', 'description': 'Death from any cause'}, {'measure': 'Ischemic stroke or TIA (transient ischemic attack)', 'timeFrame': 'From the first cardioversion through study completion, an average of 6 years', 'description': 'Ischemic stroke or TIA diagnosed by neurologist'}, {'measure': 'Major Bleed', 'timeFrame': 'From the first cardioversion through study completion, an average of 6 years', 'description': 'Major Bleeding complication according to ISTH (International Society on Thrombosis and Haemostasis)'}], 'secondaryOutcomes': [{'measure': 'Permanent oral anticoagulation', 'timeFrame': 'From the first cardioversion through study completion, an average of 6 years.', 'description': 'Initiation of permanent oral anticoagulation therapy, information on oral anticoaglation initiation done by reviewing electronic patient records'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation', 'Stroke, Ischemic']}, 'referencesModule': {'references': [{'pmid': '23850908', 'type': 'BACKGROUND', 'citation': 'Airaksinen KE, Gronberg T, Nuotio I, Nikkinen M, Ylitalo A, Biancari F, Hartikainen JE. Thromboembolic complications after cardioversion of acute atrial fibrillation: the FinCV (Finnish CardioVersion) study. J Am Coll Cardiol. 2013 Sep 24;62(13):1187-92. doi: 10.1016/j.jacc.2013.04.089. Epub 2013 Jul 10.'}]}, 'descriptionModule': {'briefSummary': 'This study explores the association of symptomatic episodes of atrial fibrillation (AF) occurrence and long-term risk of thromboembolic complications in a retrospective setting.', 'detailedDescription': 'The study population consists of the FinCV-dataset, which includes 7660 acute cardioversions for atrial fibrillation. The electronic patient records of FinCV-study patients are reviewed to collect data on anticoagulation, number of cardioversions as well as mortality and stroke data. We seek to explore the possible association between the frequency of AF paroxysms in low stroke risk patients and the occurrence of death, stroke and major bleed as well as the net clinical benefit of anticoagulation. Data collection is performed by reviewing electronic patient records.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Original FinCV study (Airaksinen et al. JACC 2013) eligibility criteria: All patients with a primary diagnosis of atrial fibrillation (ICD-10 code I48) were identified from the institutional discharge registries in the 3 participating hospitals. Emergency clinic admission records and databases were then used to review all patients (\\>18 years of age) with acute (\\<48 h) atrial fibrillation who underwent cardioversion during the study period. In addition, only patients living in the hospital catchment area were included to get the adequate follow-up data after the cardioversion.', 'healthyVolunteers': False, 'eligibilityCriteria': '* primary diagnosis of atrial fibrillation (ICD-10 code I48)\n* Cardioversion for acute (\\<48 h) atrial fibrillation\n* \\>18 years of age\n* living within the catchment area of the hospital'}, 'identificationModule': {'nctId': 'NCT04001205', 'acronym': 'FinCV-4', 'briefTitle': 'Atrial Fibrillation Burden and Long-term Risk of Thromboembolic Complications- the FinCV-4 Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Turku'}, 'officialTitle': 'Effect of Atrial Fibrillation Burden on Long-term Risk of Thromboembolic Complications- the FinCV-4 Study', 'orgStudyIdInfo': {'id': 'T75/2019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No oral anticoagulation', 'description': 'Patients without oral anticoagulation for AF'}, {'label': 'Oral anticoagulation', 'description': 'Patients with long term oral anticoagulation', 'interventionNames': ['Drug: Anticoagulation Therapy']}], 'interventions': [{'name': 'Anticoagulation Therapy', 'type': 'DRUG', 'description': 'Long term oral anticoagulation with VKA (vitamin K antagonist) or NOAC (non-vitamin K oral anticoagulant)', 'armGroupLabels': ['Oral anticoagulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20521', 'city': 'Turku', 'state': 'Southwest Finland', 'country': 'Finland', 'facility': 'Turku University Hospital, Heart Center', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Turku', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Juhani Airaksinen', 'investigatorAffiliation': 'Turku University Hospital'}}}}