Temporal Changes in Clinical Characteristics and Functions, and Their Relationship With Outcomes of Atrial Fibrillation: a Retrospective Study Utilizing Data Linkage of a Single Center Patient Data and National Claims Database in Korea
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 12,556
- Locations
- 1
- Primary Endpoint
- Event Rate of Stroke/Systemic embolism (SE)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Event Rate of Stroke/Systemic embolism (SE)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported