Effect of Atrial Fibrillation Burden on Long-term Risk of Thromboembolic Complications- the FinCV-4 Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University of Turku
- Enrollment
- 1,300
- Locations
- 1
- Primary Endpoint
- Ischemic stroke or TIA (transient ischemic attack)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Oral anticoagulation
Patients with long term oral anticoagulation
Intervention: Anticoagulation Therapy (Drug)
Outcomes
Primary Outcomes
Ischemic stroke or TIA (transient ischemic attack)
Time Frame: From the first cardioversion through study completion, an average of 6 years
Ischemic stroke or TIA diagnosed by neurologist
Major Bleed
Time Frame: From the first cardioversion through study completion, an average of 6 years
Major Bleeding complication according to ISTH (International Society on Thrombosis and Haemostasis)
Death
Time Frame: From the first cardioversion through study completion, an average of 6 years
Death from any cause
Secondary Outcomes
- Permanent oral anticoagulation(From the first cardioversion through study completion, an average of 6 years.)
Investigators
Juhani Airaksinen
Professor
Turku University Hospital