Atrial Fibrillation Data Linkage Non-Interventional Study

Not yet recruiting

• Conditions: Atrial Fibrillation

• Registration Number: NCT05810727
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to understand temporal changes in clinical features and functions, and the relationship with outcomes of atrial fibrillation (AF). AF is a problem with speed or pattern that the heart beats. It is the most common type of arrythmia. The study will use data linkage of a single center patient data and national claims database in Korea. This study does not include an actual patient enrollment process.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-15
• Study First Submitted QC: 2023-03-31
• Study First Posted: 2023-04-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-13
• Study Start: 2025-05-31
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 19388

Inclusion Criteria

• Patients had incident AF diagnosis (International Classification of Diseases 10th Revision [ICD-10]; I48) in an inpatient or outpatient setting at SNUH between 1 Jan 2010 and 31 Dec 2020
• Patients aged 18 years or older on the index date

Exclusion Criteria

• Medical claims indicating a diagnosis code indicative of rheumatic mitral valvular heart disease, mitral valve stenosis, or prosthetic heart valve during 12 months period prior to first AF diagnosis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Event Rate of Stroke/Systemic embolism (SE)	Up to 12 months after AF diagnosis or after the start date of relevant atrial fibrillation(AF) treatment	National Health Insurance Service(NHIS); Claims with the following ICD-10 diagnosis codes as main or all sub-diagnoses whichever came first (i.e., the first occurred event will be used): 1. Ischemic stroke: G45.9, I63, I69.3; 2. Hemorragic stroke: I60, I61, I62, I69.0, I69.1, I69.2; 3. Systemic embolism: I74; * Hospitalization and computed tomography (CT) or magnetic resonance imaging (MRI) codes (brain CT or MRI for ischemic stroke and hemorrhagic stroke; any CT or MRI for systemic embolism) were also required for identification.
Event Rate of Major bleeding	Up to 12 months after the AF diagnosis or after the start date of relevant AF treatment	Bleeding requiring hospitalization will be identified using hospital claims which had a bleeding diagnosis code as the first occurred ICD-10 code and will be consisted of intracranial hemorrahge (ICH), gastrointestinal (GI) bleeding, and other bleeding. Main and all sub-diagnosis codes will be used. Particularly, hospitalization and brain CT or MRI codes (as described in variable 'stroke or SE') will be needed to identify ICH.
All-Cause Mortality Rates	Up to 12 months after the AF diagnosis or after the start date of relevant AF treatment	Death will be identified from mortality registration data of Statistics Korea linked to NHIS database