Clinical trial NCT01990105: Treatment of Atrial Fibrillation in Finland
Official title: Treatment of Atrial Fibrillation in Finland - the FinFib 2 Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
anticoagulation
antiarrhythmic medication
CHA2DS2VASc score
HAS-BLED score
CHADS2 score
Lead sponsor: Finnish Cardiac Society
Sponsor class: OTHER
Collaborators: name: Helsinki University Central Hospital
name: Kuopio University Hospital
name: Oulu University Hospital
name: Tampere University Hospital
name: Turku University Hospital
First posted: 2013-11-21
Enrollment: 1013
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Working 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.

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 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.

Eligibility criteria: Inclusion Criteria:

All 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.

Exclusion Criteria:

None

Primary outcomes:
measure: Adherence to current atrial fibrillation treatment guidelines
timeFrame: Data collected during the ER visit
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Heart Center Tampere Univerisity Hospital
name: Pekka Raatikainen, MD, PhD
role: STUDY_CHAIR
affiliation: Kuopio University Hospital
name: Juha Hartikainen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oulu University Hospital
name: Timo Lauri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital
name: Mika Lehto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital
name: Markku Mäkijärvi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Turku University Hospital
name: Juha Lund, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Center Tampere University Hospital
name: Heikki Mäkynen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.