Risk Factors for Stroke or Systemic Embolism in Chinese Patients with Non-Valvular Atrial Fibrillation Registry

Recruiting

• Conditions: Atrial Fibrillation; Stroke

• Registration Number: NCT05598632
• Lead Sponsor: China National Center for Cardiovascular Diseases

Brief Summary

This study is aimed to validate the existing stroke risk stratification model for patients with atrial fibrillation (AF) (CHA2DS2-VASc Score, CHADS2 Score, ATRIA score, ABC score, etc.) and establish a new stroke risk assessment model using a nationwide AF -specific registry in China.

Detailed Description

This study is a multicenter prospective disease-specific registry of patients with atrial fibrillation (AF) that will analyze factors that are associated with stroke or systemic embolic events in patients with AF in China. Approximately 5,000 prospective cohort of patients and 22,000 retrospective cohort of patients will be enrolled. Consecutive patients who meet the eligibility criteria and provide informed consent. Patients enrolled in the registry will be followed for approximately 3 years. Patient follow-up by National Center for Cardiovascular Diseases will continue as scheduled. Atrial Fibrillation Data capture will include demographics, cardiovascular risk factors, diagnosis, type of AF (paroxysmal, persistent, permanent AF), treatment strategy (rate vs. rhythm), antithrombotic therapy, concomitant medications and doses, laboratory tests, echo and computed tomography results, blood sample, insurance and provider information, comorbidities, and outcomes. The primary outcome will be stroke or non-CNS embolism. Other pre-defined outcomes of interest will include major adverse cardiac events, all-cause mortality, cause-specific death (sudden, non-sudden, heart failure-related), major bleeding, and hospitalization for heart failure.

Study Timeline

• Study First Submitted: 2022-10-26
• Study First Submitted QC: 2022-10-26
• Study First Posted: 2022-10-28
• Study Start: 2023-04-18
• Status Verified: 2024-10
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 22000

Inclusion Criteria

• 18 years of age or older; male or female.
• History of documented atrial fibrillation.
• Able to provide written informed consent.

Exclusion Criteria

• Subjects with moderate or severe mitral stenosis or a mechanical heart valve
• Subjects with previous or planned AF ablation.
• Subjects with previous or planned left atrial appendage closure.
• Subjects unable to cooperate with follow-up after assessment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite of Stroke and Systemic Embolic Events (SEE)	At 12-month after recruiting	The composite of stroke and Systemic Embolic Events (SEE) during follow-up. A stroke is defined as an abrupt onset, over minutes to hours, of a focal neurologic deficit that is generally in the distribution of a single brain artery (including the retinal artery) and that is not due to an identifiable nonvascular cause (ie, brain tumor or trauma).; A systemic embolic event is defined as an abrupt episode of arterial insufficiency associated with clinical or radiologic evidence of arterial occlusion in the absence of other likely mechanisms (eg, atherosclerosis, instrumentation). Arterial embolic events involving the central nervous system (including the eye), coronary, and pulmonary arterial circulation are not considered SEEs,. Diagnosis of embolism to the lower extremities requires arteriographic demonstration of abrupt arterial occlusion.

Secondary Outcome Measures

Name	Time	Method
All-Cause Mortality	At 12-month after recruiting	All-Cause Mortality during follow-up
Major Bleeding Events	At 12-month after recruiting	A major bleeding event is defined as clinically overt bleeding event (ie, bleeding that is visualized by examination or radiologic imaging) that meets ≥1 of the following: 1. Fatal bleeding; 2. Symptomatic bleeding in a critical area or organ such as: * Retroperitoneal; * Intracranial; * Intraocular; * Intraspinal; * Intraarticular; * Pericardial; * Intramuscular with compartment syndrome
Cardiac Death	At 12-month after recruiting	Cardiac Death during follow-up
Hospitalization for heart failure	At 12-month after recruiting	Hospitalization for heart failure during follow-up

Trial Locations

Locations (1)

Fuwai Hospital, CAMS & PUMC; 🇨🇳 Beijing, Beijing, China