Clinical trial NCT04001205: Atrial Fibrillation Burden and Long-term Risk of Thromboembolic Complications- the FinCV-4 Study
Official title: Effect of Atrial Fibrillation Burden on Long-term Risk of Thromboembolic Complications- the FinCV-4 Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atrial Fibrillation
Stroke, Ischemic
Lead sponsor: University of Turku
Sponsor class: OTHER
First posted: 2019-06-27
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: This study explores the association of symptomatic episodes of atrial fibrillation (AF) occurrence and long-term risk of thromboembolic complications in a retrospective setting.

Detailed description: 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.

Eligibility criteria: * primary diagnosis of atrial fibrillation (ICD-10 code I48)
* Cardioversion for acute (\<48 h) atrial fibrillation
* \>18 years of age
* living within the catchment area of the hospital

Primary outcomes:
measure: Death
timeFrame: From the first cardioversion through study completion, an average of 6 years
measure: Ischemic stroke or TIA (transient ischemic attack)
timeFrame: From the first cardioversion through study completion, an average of 6 years
measure: Major Bleed
timeFrame: From the first cardioversion through study completion, an average of 6 years
Secondary outcomes:
measure: Permanent oral anticoagulation
timeFrame: From the first cardioversion through study completion, an average of 6 years.
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital, Heart Center
state: Varsinais-suomi
Study officials:
References:
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.