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Rationale, design and protocol for risk factors for stroke in patients with non-valvular atrial fibrillation in China: a nationwide registry (REFINE registry)

Por: 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 · Ma · Yu · Chai · Dong · Wang · Gan · Zhao · Jin · Liu · Zhang · Wang · Yao · Zheng · Liu · Du · Guo · Zhang
Introduction

Atrial fibrillation (AF), the most common sustained arrhythmia globally, necessitates effective strategies for stroke prevention. Although current risk stratification tools, such as the CHA2DS2-VASc score, are widely used to guide anticoagulation therapy, their limited predictive accuracy underscores the urgent need for more precise and reliable models. This study aims to establish a nationwide AF registry incorporating multi-dimensional data to identify novel risk factors and develop a more accurate stroke prediction model to improve risk stratification and guide anticoagulation therapy in patients with AF.

Methods/analysis

The risk factors for stroke in patients with non-valvular AF in China (REFINE) registry is a nationwide, multicentre, observational registry integrating retrospective (n=20 000) and prospective (n=5000) cohorts. Demographics, lifestyle, medical history, physical examination, laboratory tests, ECG, echocardiography, contrast-enhanced CT scan and blood samples will be collected at baseline. Long-term follow-up will be performed to identify clinical events and treatment at the timepoint. We aim to use the multidimensional dataset to establish a more precise stroke risk predictive tool.

Ethics and dissemination

The study is approved by the Ethics Committee of Fuwai Hospital, CAMS&PUMC (No. 2022–1845; No. 2024–2489) and registered at ClinicalTrials.gov, identifier NCT05598632. The results of this study will be disseminated through publications in peer-­reviewed journals and conference presentations.

Trial registration number

NCT05598632.

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