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

NCT04001205 | Active Not Recruiting

• 1 other identifier: T75/2019
• Study Type: observational
• Target: 1,300
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Stroke, Ischemic

Outcome Measures

Primary Outcomes (3)

• Death

  Death from any cause

  From the first cardioversion through study completion, an average of 6 years

• Ischemic stroke or TIA (transient ischemic attack)

  Ischemic stroke or TIA diagnosed by neurologist

  From the first cardioversion through study completion, an average of 6 years

• Major Bleed

  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 Outcomes (1)

• Permanent oral anticoagulation

  From the first cardioversion through study completion, an average of 6 years.

Study Arms (2)

No oral anticoagulation

Patients without oral anticoagulation for AF

Oral anticoagulation

Patients with long term oral anticoagulation

Drug: Anticoagulation Therapy

Interventions

Anticoagulation Therapy DRUG

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

Oral anticoagulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Turku: lead

Study Sites (1)

Turku University Hospital, Heart Center

Turku, Southwest Finland, 20521, Finland

Location

Related Publications (1)

• 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.

  PMID: 23850908 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Ischemic Stroke

Interventions

Anticoagulation Bridge

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Bridge Therapy; Therapeutics

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 21, 2019
• First Posted: June 27, 2019
• Study Start: June 1, 2019
• Primary Completion: January 8, 2025
• Study Completion: January 8, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

FI (1)