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

NCT ID: NCT04001205

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-01

Study Completion Date

2025-01-08

Brief Summary

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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

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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.

Conditions

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Atrial Fibrillation Stroke, Ischemic

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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No oral anticoagulation

Patients without oral anticoagulation for AF

No interventions assigned to this group

Oral anticoagulation

Patients with long term oral anticoagulation

Anticoagulation Therapy

Intervention Type DRUG

Long term oral anticoagulation with VKA (vitamin K antagonist) or NOAC (non-vitamin K oral anticoagulant)

Interventions

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Anticoagulation Therapy

Long term oral anticoagulation with VKA (vitamin K antagonist) or NOAC (non-vitamin K oral anticoagulant)

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Turku

OTHER

Sponsor Role lead

Responsible Party

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Juhani Airaksinen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Turku University Hospital, Heart Center

Turku, Southwest Finland, Finland

Site Status

Countries

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Finland

References

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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.

Reference Type BACKGROUND
PMID: 23850908 (View on PubMed)

Other Identifiers

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T75/2019

Identifier Type: -

Identifier Source: org_study_id

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