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中东和非洲的心房颤动真实世界管理注册研究:设计与原理。

The atrial FibriLlatiOn real World management registry in the Middle East and Africa: design and rationale.

机构信息

Alexandria University, Alexandria, Egypt.

American University of Beirut-Medical Center, Beirut, Lebanon.

出版信息

J Cardiovasc Med (Hagerstown). 2020 Sep;21(9):704-710. doi: 10.2459/JCM.0000000000001007.

DOI:10.2459/JCM.0000000000001007
PMID:32576751
Abstract

BACKGROUND

Atrial fibrillation is the most common cardiac arrhythmia, affecting 33.5 million patients globally. It is associated with increased morbidity, leading to significant clinical and economic burden. There exist only limited data in the Middle Eastern region from the existing registries. The goal of the FLOW-AF (atrial FibriLlatiOn real World management registry in the Middle East and Africa) registry is to evaluate the characteristics, treatment patterns, and clinical and economic outcomes associated with anticoagulation among patients newly diagnosed with nonvalvular atrial fibrillation in Egypt, Lebanon, the Kingdom of Saudi Arabia, and the United Arab Emirates.

METHODS

This study will be a multicountry, multicenter, prospective observational registry aiming to enroll 1446 newly diagnosed nonvalvular atrial fibrillation patients at more than 20 sites across the four countries. During the recruitment period, patients will be included if they were newly diagnosed with nonvalvular atrial fibrillation and had initiated treatment for the prevention of stroke/systemic embolism. Patient data will be assessed prospectively at 6 and 12 months from their enrollment date. Demographics, clinical characteristics, antithrombotic treatments received, clinical outcomes, adverse events, healthcare resource utilization, and direct costs associated with management of nonvalvular atrial fibrillation will be collected and analyzed overall, by country, and by groups created based on treatment, demographics, and clinical characteristics, medical history and risk factors.

CONCLUSION

The FLOW-AF registry will provide information on the uptake of oral anticoagulants, treatment patterns, clinical outcomes, and healthcare utilization and costs among newly diagnosed nonvalvular atrial fibrillation patients in the Middle Eastern region.

摘要

背景

心房颤动是最常见的心律失常,影响全球 3350 万患者。它与发病率增加有关,导致重大的临床和经济负担。现有的登记处中,只有中东地区有限的数据。FLOW-AF(中东和非洲心房颤动真实世界管理登记处)登记处的目标是评估埃及、黎巴嫩、沙特阿拉伯王国和阿拉伯联合酋长国新诊断为非瓣膜性心房颤动患者的特征、治疗模式以及与抗凝相关的临床和经济结局。

方法

本研究将是一项多国家、多中心、前瞻性观察性登记研究,旨在四个国家的 20 多个地点招募 1446 名新诊断的非瓣膜性心房颤动患者。在招募期间,如果患者新诊断为非瓣膜性心房颤动且已开始进行预防中风/全身性栓塞的治疗,将纳入患者。将从患者入组日期起的 6 个月和 12 个月时前瞻性评估患者数据。将收集和分析总体、按国家以及按治疗、人口统计学和临床特征、病史和风险因素分组的患者人口统计学、临床特征、抗血栓治疗、临床结局、不良事件、医疗资源利用和非瓣膜性心房颤动管理的直接成本。

结论

FLOW-AF 登记处将提供有关中东地区新诊断的非瓣膜性心房颤动患者口服抗凝剂的使用情况、治疗模式、临床结局以及医疗保健利用和成本的信息。

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