Stroke Clinical Trial
Official title:
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.
Status | Not yet recruiting |
Enrollment | 17000 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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China National Center for Cardiovascular Diseases |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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:
Fatal bleeding Symptomatic bleeding in a critical area or organ such as: Retroperitoneal Intracranial Intraocular Intraspinal Intraarticular Pericardial Intramuscular with compartment syndrome |
At 12-month after recruiting | |
Secondary | All-Cause Mortality | All-Cause Mortality during follow-up | At 12-month after recruiting | |
Secondary | Cardiac Death | Cardiac Death during follow-up | At 12-month after recruiting | |
Secondary | Hospitalization for heart failure | Hospitalization for heart failure during follow-up | At 12-month after recruiting |
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