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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Major Bleeding Events | 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:
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Inclusion Criteria:
Exclusion Criteria:
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Atrial fibrillation patients without valvular heart disease, prevous/planned ablation or left atrial appendage closure.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhe Zheng, MD, PhD | Contact | +86-010-88396051 | zhengzhe@fuwai.com | |
| Shuo Yuan, MD | Contact | yuanshuo@fuwai.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhe Zheng, MD, PhD | Fuwai Hospital, Chinese Academy of Medical Science | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital, CAMS & PUMC | Recruiting | Beijing | Beijing Municipality | 100027 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41193204 | Derived | 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. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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Plasma sample
| At 12-month after recruiting |
| All-Cause Mortality | All-Cause Mortality during follow-up | At 12-month after recruiting |
| Cardiac Death | Cardiac Death during follow-up | At 12-month after recruiting |
| Hospitalization for heart failure | Hospitalization for heart failure during follow-up | At 12-month after recruiting |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |