Atrial Fibrillation Burden and Long-term Risk of Thromboembolic Complications- the FinCV-4 Study

Active, not recruiting

• Conditions: Stroke, Ischemic; Atrial Fibrillation
• Interventions: Drug: Anticoagulation Therapy

• Registration Number: NCT04001205
• Lead Sponsor: University of Turku

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 Timeline

• Study Start: 2019-06-01
• Study First Submitted: 2019-06-21
• Study First Submitted QC: 2019-06-26
• Study First Posted: 2019-06-27
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08
• Primary Completion: 2025-01-08
• Study Completion: 2025-01-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Oral anticoagulation	Anticoagulation Therapy	Patients with long term oral anticoagulation

Primary Outcome Measures

Name	Time	Method
Ischemic stroke or TIA (transient ischemic attack)	From the first cardioversion through study completion, an average of 6 years	Ischemic stroke or TIA diagnosed by neurologist
Major Bleed	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	From the first cardioversion through study completion, an average of 6 years	Death from any cause

Secondary Outcome Measures

Name	Time	Method
Permanent oral anticoagulation	From the first cardioversion through study completion, an average of 6 years.	Initiation of permanent oral anticoagulation therapy, information on oral anticoaglation initiation done by reviewing electronic patient records

Trial Locations

Locations (1)

Turku University Hospital, Heart Center; 🇫🇮 Turku, Varsinais-suomi, Finland