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

Last updated: November 4, 2024
Sponsor: China National Center for Cardiovascular Diseases
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Arrhythmia

Circulation Disorders

Treatment

N/A

Clinical Study ID

NCT05598632
2021-CXGC09-1
  • Ages 18-120
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years of age or older; male or female.

  • History of documented atrial fibrillation.

  • Able to provide written informed consent.

Exclusion

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

Total Participants: 22000
Study Start date:
April 18, 2023
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Fuwai Hospital, CAMS & PUMC

    Beijing, Beijing 100027
    China

    Active - Recruiting

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