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

NCT05598632 | Recruiting

• 1 other identifier: 2021-CXGC09-1
• Study Type: observational
• Target: 22,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Stroke

Keywords

Stroke; Atrial fibrillation; Risk factors; Registry

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Major Bleeding Events

  At 12-month after recruiting

• All-Cause Mortality

  At 12-month after recruiting

• Cardiac Death

  At 12-month after recruiting

• Hospitalization for heart failure

  At 12-month after recruiting

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai Hospital, CAMS & PUMC

Beijing, Beijing Municipality, 100027, China

RECRUITING

Related Publications (1)

• Qi W, Yuan S, Liu H, Xu M, Yang Y, Peng X, Hu Z, Zhang Y, Zhao Y, Zheng L, Yao Y, Zheng Z; Investigators the REFINE Registry; investors. Rationale, design and protocol for risk factors for stroke in patients with non-valvular atrial fibrillation in China: a nationwide registry (REFINE registry). BMJ Open. 2025 Nov 4;15(11):e104806. doi: 10.1136/bmjopen-2025-104806.

  PMID: 41193204 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Plasma sample

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Zhe Zheng, MD, PhD

  Fuwai Hospital, Chinese Academy of Medical Science

  STUDY CHAIR

Central Study Contacts

Zhe Zheng, MD, PhD

CONTACT

+86-010-88396051; zhengzhe@fuwai.com

Shuo Yuan, MD

CONTACT

yuanshuo@fuwai.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: October 28, 2022
• Study Start: April 18, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: November 6, 2024

Record last verified: 2024-10

Locations

CN (1)