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

May 7, 2024 updated by: Juhani Airaksinen, University of Turku

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

1300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Varsinais-suomi
      • Turku, Varsinais-suomi, Finland, 20521
        • Turku University Hospital, Heart Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
No oral anticoagulation
Patients without oral anticoagulation for AF
Oral anticoagulation
Patients with long term oral anticoagulation
Drug: Anticoagulation Therapy
Long term oral anticoagulation with VKA (vitamin K antagonist) or NOAC (non-vitamin K oral anticoagulant)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: From the first cardioversion through study completion, an average of 6 years
Death from any cause
From the first cardioversion through study completion, an average of 6 years
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
From the first cardioversion through study completion, an average of 6 years
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)
From the first cardioversion through study completion, an average of 6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Permanent oral anticoagulation
Time Frame: 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
From the first cardioversion through study completion, an average of 6 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turku

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Estimated)

January 8, 2025

Study Completion (Estimated)

January 8, 2025

Study Registration Dates

First Submitted

June 21, 2019

First Submitted That Met QC Criteria

June 26, 2019

First Posted (Actual)

June 27, 2019

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T75/2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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