Department of Cardiology and Vascular Medicine, Faculty of Medicine, Universitas Indonesia, National Cardiovascular Center Harapan Kita.
Pasar Rebo General Hospital.
Medicine (Baltimore). 2021 May 14;100(19):e25725. doi: 10.1097/MD.0000000000025725.
Data on the optimal therapeutic international normalized ratio (INR) for non-valvular and valvular atrial fibrillation (AF) in Indonesia is currently unavailable. Therefore, we designed the Indonesian Registry on Atrial Fibrillation (OneAF) registry in order to seek a safe and beneficial range of INR in Indonesian patients with non-valvular and valvular AF.
METHODS/DESIGN: The OneAF registry is a nationwide collaboration of the Indonesian Heart Rhythm Society (InaHRS) enrolling all hospitals with cardiac electrophysiologists in Indonesia. It is a prospective, multicentre, nationwide, observational study aiming to recruit non-valvular and valvular AF patients in Indonesia. The registry was started in January 2020 with a planned 2 years of recruitment. There are 2 respondents for this registry: non-cohort and cohort respondents. Non-cohort registry respondents are AF patients at hospitals who fulfill inclusion and exclusion criteria but did not consent for a 24 month follow up. Whereas patients who consented for a 24 month follow up were included as cohort registry respondents. Key data collected includes basic sociodemographic information, symptoms and signs, medical history, results of physical examination and laboratory test, details of diagnostics and treatment measures and events.
Currently, a total of 1568 respondents have been enrolled in the non-cohort registry, including 1065 respondents with non-valvular AF (67.8%) and 503 respondents with valvular AF (32.2%). We believe that the OneAF registry will provide insight into the regional variability of anticoagulant treatment for AF, the implementation of rhythm/rate control approaches, and the clinical outcomes concerning cardiocerebrovascular events.
Registered at clinicaltrials.gov (NCT04222868).
目前，印度尼西亚缺乏关于非瓣膜性和瓣膜性心房颤动（AF）的最佳治疗国际标准化比值（INR）的数据。因此，我们设计了印度尼西亚心房颤动登记研究（OneAF），旨在为印度尼西亚非瓣膜性和瓣膜性 AF 患者寻找安全且有益的 INR 范围。
方法/设计：OneAF 登记研究是印度尼西亚心律协会（InaHRS）的全国性合作项目，纳入了印度尼西亚所有有心脏电生理学家的医院。这是一项前瞻性、多中心、全国性、观察性研究，旨在招募印度尼西亚的非瓣膜性和瓣膜性 AF 患者。该登记研究于 2020 年 1 月开始，计划招募 2 年。该登记研究有 2 位应答者：非队列和队列应答者。非队列登记应答者是符合纳入和排除标准但不同意进行 24 个月随访的医院 AF 患者。而同意进行 24 个月随访的患者则被纳入队列登记应答者。收集的关键数据包括基本社会人口统计学信息、症状和体征、病史、体检和实验室检查结果、诊断和治疗措施以及事件的详细信息。
目前，共有 1568 名应答者已被纳入非队列登记研究，其中 1065 名应答者患有非瓣膜性 AF（67.8%），503 名应答者患有瓣膜性 AF（32.2%）。我们相信，OneAF 登记研究将提供有关 AF 抗凝治疗的区域性差异、节律/心率控制方法的实施以及与心血管事件相关的临床结果的信息。
在 clinicaltrials.gov 注册（NCT04222868）。
