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

China National Center for Cardiovascular Diseases (Other)
Overall Status
Not yet recruiting
CT.gov ID

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Anticipated Enrollment :
    17000 participants
    Observational Model:
    Time Perspective:
    Official Title:
    Risk Factors for Stroke or Systemic Embolism in Chinese Patients With Non-Valvular Atrial Fibrillation Registry
    Anticipated Study Start Date :
    Nov 10, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2024
    Anticipated Study Completion Date :
    Dec 31, 2025

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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: Fatal bleeding Symptomatic bleeding in a critical area or organ such as: Retroperitoneal Intracranial Intraocular Intraspinal Intraarticular Pericardial Intramuscular with compartment syndrome

    2. All-Cause Mortality [At 12-month after recruiting]

      All-Cause Mortality during follow-up

    3. Cardiac Death [At 12-month after recruiting]

      Cardiac Death during follow-up

    4. Hospitalization for heart failure [At 12-month after recruiting]

      Hospitalization for heart failure during follow-up

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    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.

    Contacts and Locations


    No locations specified.

    Sponsors and Collaborators

    • China National Center for Cardiovascular Diseases


    • Study Chair: Zhe Zheng, MD, PhD, Fuwai Hospital, Chinese Academy of Medical Science

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    China National Center for Cardiovascular Diseases
    ClinicalTrials.gov Identifier:
    Other Study ID Numbers:
    • 2021-CXGC09-1
    First Posted:
    Oct 28, 2022
    Last Update Posted:
    Oct 28, 2022
    Last Verified:
    Oct 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Keywords provided by China National Center for Cardiovascular Diseases
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 28, 2022