Clinical trial NCT05598632: Risk Factors for Stroke or Systemic Embolism in Chinese Patients with Non-Valvular Atrial Fibrillation Registry
Official title: Risk Factors for Stroke or Systemic Embolism in Chinese Patients with Non-Valvular Atrial Fibrillation Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Stroke
Keywords: Stroke
Atrial fibrillation
Risk factors
Registry
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2022-10-28
Enrollment: 22000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Atrial fibrillation patients without valvular heart disease, prevous/planned ablation or left atrial appendage closure.

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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Composite of Stroke and Systemic Embolic Events (SEE)
timeFrame: At 12-month after recruiting
Secondary outcomes:
measure: Major Bleeding Events
timeFrame: At 12-month after recruiting
measure: All-Cause Mortality
timeFrame: At 12-month after recruiting
measure: Cardiac Death
timeFrame: At 12-month after recruiting
measure: Hospitalization for heart failure
timeFrame: At 12-month after recruiting
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, CAMS & PUMC
state: Beijing
Study officials:
affiliation: Fuwai Hospital, Chinese Academy of Medical Science
name: Zhe Zheng, MD, PhD
role: STUDY_CHAIR
References: