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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05598632
Other study ID # 2021-CXGC09-1
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 10, 2022
Est. completion date December 31, 2025

Study information

Verified date October 2022
Source China National Center for Cardiovascular Diseases
Contact Zhe Zheng, MD, PhD
Phone +86-010-88396051
Email zhengzhe@fuwai.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 17,000 prospective 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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
China National Center for Cardiovascular Diseases

Outcome

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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