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NCT Number: NCT05598632

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.

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Key information

Conditions

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

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fuwai Hospital, CAMS & PUMC

Beijing, Beijing Municipality, 100027, China

Location status: Recruiting

Location contact

Yan Yao, MD, PhD

CONTACT

[email protected]

+86 187 0101 3797

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Composite of Stroke and Systemic Embolic Events (SEE)

    Time frame: 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 outcomes

  1. Major Bleeding Events

    Time frame: 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

    Time frame: At 12-month after recruiting

    All-Cause Mortality during follow-up

  3. Cardiac Death

    Time frame: At 12-month after recruiting

    Cardiac Death during follow-up

  4. Hospitalization for heart failure

    Time frame: At 12-month after recruiting

    Hospitalization for heart failure during follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Shuo Yuan, MD

CONTACT

[email protected]

Zhe Zheng, MD, PhD

CONTACT

[email protected]

+86-010-88396051

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Oct 28, 2022
Registry last updated
Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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