Atrial Fibrillation Data Linkage Non-Interventional Study

Atrial Fibrillation Clinical Trial

Official title:

Temporal Changes in Clinical Characteristics and Functions, and Their Relationship With Outcomes of Atrial Fibrillation: a Retrospective Study Utilizing Data Linkage of a Signle Center Patient Data and National Claims Database in Korea

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05810727
• Other study ID #: B0661188
• Secondary ID: Eliquis AF data
• Status: Not yet recruiting
• Start date: July 31, 2024
• Est. completion date: October 31, 2024

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 19388
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event Rate of Stroke/Systemic embolism (SE)	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): Ischemic stroke: G45.9, I63, I69.3; Hemorragic stroke: I60, I61, I62, I69.0, I69.1, I69.2; 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.	Up to 12 months after AF diagnosis or after the start date of relevant atrial fibrillation(AF) treatment
Primary	Event Rate of Major bleeding	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.	Up to 12 months after the AF diagnosis or after the start date of relevant AF treatment
Primary	All-Cause Mortality Rates	Death will be identified from mortality registration data of Statistics Korea linked to NHIS database	Up to 12 months after the AF diagnosis or after the start date of relevant AF treatment