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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05598632
• Other study ID #: 2021-CXGC09-1
• Status: Not yet recruiting
• Start date: November 10, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2022
• Source: China National Center for Cardiovascular Diseases
• Contact: Zhe Zheng, MD, PhD
• Phone: +86-010-88396051
• Email: zhengzhe[@]fuwai.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 17000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Embolism
• Stroke

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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: Retroperitoneal; Intracranial; Intraocular; Intraspinal; Intraarticular; Pericardial; Intramuscular with compartment syndrome	At 12-month after recruiting
Secondary	All-Cause Mortality	All-Cause Mortality during follow-up	At 12-month after recruiting
Secondary	Cardiac Death	Cardiac Death during follow-up	At 12-month after recruiting
Secondary	Hospitalization for heart failure	Hospitalization for heart failure during follow-up	At 12-month after recruiting