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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke; Atrial Fibrillation

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 17,000 prospective 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 Type: Observational
• Enrollment (Anticipated): 17000

Contacts and Locations

• Study Contact: Name: Zhe Zheng, MD, PhD; Phone Number: +86-010-88396051; Email: zhengzhe@fuwai.com
• Study Contact Backup: Name: Shuo Yuan, MD; Email: yuanshuo@fuwai.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 118 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Atrial fibrillation patients without valvular heart disease, prevous/planned ablation or left atrial appendage closure.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of Stroke and Systemic Embolic Events (SEE)	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.	At 12-month after recruiting

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Bleeding Events	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: Fatal bleeding; Symptomatic bleeding in a critical area or organ such as:RetroperitonealIntracranialIntraocularIntraspinalIntraarticularPericardialIntramuscular with compartment syndrome	At 12-month after recruiting
All-Cause Mortality	All-Cause Mortality during follow-up	At 12-month after recruiting
Cardiac Death	Cardiac Death during follow-up	At 12-month after recruiting
Hospitalization for heart failure	Hospitalization for heart failure during follow-up	At 12-month after recruiting

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Investigators: Study Chair: Zhe Zheng, MD, PhD, Fuwai Hospital, Chinese Academy of Medical Science

Study record dates

Study Major Dates

• Study Start (Anticipated): November 10, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: October 26, 2022
• First Posted (Actual): October 28, 2022

Study Record Updates

• Last Update Posted (Actual): October 28, 2022
• Last Update Submitted That Met QC Criteria: October 26, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Stroke; Atrial fibrillation; Risk factors; Registry
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Embolism and Thrombosis; Arrhythmias, Cardiac; Stroke; Embolism; Atrial Fibrillation
• Other Study ID Numbers: 2021-CXGC09-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No