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Published on: February 26, 2013
Rationale, design and protocol for risk factors for stroke in patients with non-valvular atrial fibrillation in
Wenwei Qi1,2, Shuo Yuan1,2, Hanning Liu1,2,3
1National Clinical Research Centre of Cardiovascular Diseases, Fuwai Hospital, National Centre for Cardiovascular Diseases, Beijing, China.
Insights
This study establishes a nationwide Atrial Fibrillation (AF) registry to identify new stroke risk factors. The goal is to create a more accurate prediction model for better stroke prevention in AF patients.
Area of Science:
- Cardiology
- Epidemiology
- Medical Informatics
Background:
- Atrial fibrillation (AF) is the most common sustained arrhythmia globally.
- Current stroke risk stratification tools for AF, like CHA₂DS₂-VASc, have limited predictive accuracy.
- There is an urgent need for more precise models to guide anticoagulation therapy.
Purpose of the Study:
- To establish a nationwide AF registry with multi-dimensional data.
- To identify novel risk factors for stroke in AF patients.
- To develop a more accurate stroke prediction model for improved risk stratification and anticoagulation guidance.
Main Methods:
- The Risk Factors for Stroke in Patients with Non-valvular AF in China (REFINE) registry is a nationwide, multicentre, observational study.
- It integrates retrospective (20,000 patients) and prospective (5,000 patients) cohorts.
- Comprehensive baseline data (demographics, lifestyle, medical history, labs, imaging) and long-term follow-up will be collected.
Main Results:
- Data collection and registry establishment are underway.
- Analysis of the multidimensional dataset is planned to identify novel stroke risk factors.
- Development of a more precise stroke risk predictive tool is the primary objective.
Conclusions:
- The REFINE registry aims to significantly enhance stroke risk prediction in AF patients.
- This will lead to more personalized and effective anticoagulation strategies.
- The findings are expected to improve clinical decision-making and patient outcomes in AF management.
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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