Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-02-28 @ 3:53 AM
Study NCT ID:
NCT01990105
Status:
COMPLETED
Last Update Posted:
2015-03-09
First Post:
2013-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Atrial Fibrillation in Finland
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1013}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-06', 'studyFirstSubmitDate': '2013-11-15', 'studyFirstSubmitQcDate': '2013-11-20', 'lastUpdatePostDateStruct': {'date': '2015-03-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence to current atrial fibrillation treatment guidelines', 'timeFrame': 'Data collected during the ER visit', 'description': 'All patients with ECG-diagnosed AF who attend emergency clinics for examination or treatment of arrhythmia or other cardiac diseases during the study period will be included for assessment of the adherence of their treatment to current guidelines.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['atrial fibrillation', 'anticoagulation', 'antiarrhythmic medication', 'CHA2DS2VASc score', 'HAS-BLED score', 'CHADS2 score'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '28810904', 'type': 'DERIVED', 'citation': 'Penttila T, Makynen H, Hartikainen J, Hyppola H, Lauri T, Lehto M, Lund J, Raatikainen MJP; FinFib2 investigators. Antiarrhythmic drug therapy among patients presenting to emergency department with symptomatic atrial fibrillation - a prospective nationwide cohort. Scand J Trauma Resusc Emerg Med. 2017 Aug 15;25(1):81. doi: 10.1186/s13049-017-0424-7.'}]}, 'descriptionModule': {'briefSummary': 'FINFIB 2 is an observational investigator-driven study that seeks to examine current treatment practice for atrial fibrillation in Finland. The investigators hypothesis is that the treatment of atrial fibrillation has improved since the introduction of new antiarrhythmic drugs and anticoagulants.', 'detailedDescription': 'FINFIB 2 is an observational investigator-driven study that seeks to examine current treatment practice for atrial fibrillation (AF) in Finland. It will produce important information such as whether the introduction of the new agents has taken place in accordance with the treatment guidelines in different parts of Finland.\n\nWorking hypothesis is that the treatment of AF has improved since the introduction of new antiarrhythmic drugs and anticoagulants. However, the investigators also expect to find out that there are geographical differences in the use of these agents. The expect outcome is that the investigators will identify these differences and be able to better homogenize the treatment of AF in different parts of the country and different levels of the health care system.\n\nThe study data will be obtained in the form of a cross-section sampling over two weeks. All patients with ECG-diagnosed AF who attend emergency clinics for examination or treatment of arrhythmia or other cardiac diseases during the study period will be included. The investigators estimate the number of patients will be about 1000. Aside from background information, risk data (e.g. CHA2DS2VASc), symptoms (EHRA classification), medication, examinations and the choice of treatment, the only data recorded about each patient with AF will be date of birth and gender. The patients will be divided into four groups according to type of AF: 1. New onset AF, 2. Paroxysmal AF, 3. Persistent AF, 4. Permanent AF. The data will be obtained by the local study doctor using online, protected data collection program. The data will be stored on a secured server, which can be accessed for data entry by the investigators at the study centers. The database is not a personal data register, as identity codes will not be stored at any point and individual patients cannot be identified later through the database. Only the investigator group will have the rights to use the database.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study data will be obtained in the form of a cross-section sampling over two weeks. All patients with ECG-diagnosed AF who attend emergency clinics for examination or treatment of arrhythmia or other cardiac diseases during the study period will be included. The estimated number of patients is about 1000.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll adult patients with ECG-diagnosed AF who attend emergency clinics for examination or treatment of arrhythmia or other cardiac diseases during the study period will be included.\n\nExclusion Criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT01990105', 'acronym': 'FinFib2', 'briefTitle': 'Treatment of Atrial Fibrillation in Finland', 'organization': {'class': 'OTHER', 'fullName': 'Finnish Cardiac Society'}, 'officialTitle': 'Treatment of Atrial Fibrillation in Finland - the FinFib 2 Study', 'orgStudyIdInfo': {'id': 'FCS-2013-1'}, 'secondaryIdInfos': [{'id': 'R13044', 'type': 'OTHER', 'domain': 'The Pirkanmaa Hospital District Ethical Committee'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with AF in the ER', 'description': 'All patients with ECG-diagnosed AF who attend emergency clinics for examination or treatment of arrhythmia or other cardiac diseases during the study period will be included.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Helsinki', 'country': 'Finland', 'facility': 'Helsinki University Central Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'city': 'Kuopio', 'country': 'Finland', 'facility': 'Kuopio University Hospital', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}, {'city': 'Oulu', 'country': 'Finland', 'facility': 'Oulu University Hospital', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}, {'city': 'Tampere', 'country': 'Finland', 'facility': 'Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'city': 'Turku', 'country': 'Finland', 'facility': 'Turku University Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'overallOfficials': [{'name': 'Pekka Raatikainen, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Heart Center Tampere Univerisity Hospital'}, {'name': 'Juha Hartikainen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kuopio University Hospital'}, {'name': 'Timo Lauri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oulu University Hospital'}, {'name': 'Mika Lehto, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helsinki University Central Hospital'}, {'name': 'Markku Mäkijärvi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helsinki University Central Hospital'}, {'name': 'Juha Lund, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Turku University Hospital'}, {'name': 'Heikki Mäkynen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heart Center Tampere University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Finnish Cardiac Society', 'class': 'OTHER'}, 'collaborators': [{'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, {'name': 'Kuopio University Hospital', 'class': 'OTHER'}, {'name': 'Oulu University Hospital', 'class': 'OTHER'}, {'name': 'Tampere University Hospital', 'class': 'OTHER'}, {'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}