PDF(Pubmed)
Abstract：
BACKGROUND: Paroxysmal atrial fibrillation (AF) is a probable cause of cryptogenic stroke (CS), and its detection and treatment are important for the secondary prevention of stroke. Insertable cardiac monitors (ICMs) are clinically effective in screening for AF and are superior to conventional short-term cardiac monitoring. Japanese guidelines for determining clinical indications for ICMs in CS are stricter than those in Western countries. Differences between Japanese and Western guidelines may impact the detection rate and prediction of AF via ICMs in patients with CS. Available data on Japanese patients are limited to small retrospective studies. Furthermore, additional information about AF detection, including the number of episodes, cumulative episode duration, anticoagulation initiation (type and dose of regimen and time of initiation), rate of catheter ablation, role of atrial cardiomyopathy, and stroke recurrence (time of recurrence and cause of the recurrent event), was not provided in the vast majority of previously published studies.
OBJECTIVE: In this study, we aim to identify the proportion and timing of AF detection and risk stratification criteria in patients with CS in real-world settings in Japan.
METHODS: This is a multicenter, prospective, observational study that aims to use ICMs to evaluate the proportion, timing, and characteristics of AF detection in patients diagnosed with CS. We will investigate the first detection of AF within the initial 6, 12, and 24 months of follow-up after ICM implantation. Patient characteristics, laboratory data, atrial cardiomyopathy markers, serial magnetic resonance imaging findings at baseline, 6, 12, and 24 months after ICM implantation, electrocardiogram readings, transesophageal echocardiography findings, cognitive status, stroke recurrence, and functional outcomes will be compared between patients with AF and patients without AF. Furthermore, we will obtain additional information regarding the number of AF episodes, duration of cumulative AF episodes, and time of anticoagulation initiation.
RESULTS: Study recruitment began in February 2020, and thus far, 213 patients have provided written informed consent and are currently in the follow-up phase. The last recruited participant (May 2021) will have completed the 24-month follow-up in May 2023. The main results are expected to be submitted for publication in 2023.
CONCLUSIONS: The findings of this study will help identify AF markers and generate a risk scoring system with a novel and superior screening algorithm for occult AF detection while identifying candidates for ICM implantation and aiding the development of diagnostic criteria for CS in Japan.
BACKGROUND: UMIN Clinical Trial Registry UMIN000039809; https://tinyurl.com/3jaewe6a.
UNASSIGNED: DERR1-10.2196/39307.
OBJECTIVE: In this study, we aim to identify the proportion and timing of AF detection and risk stratification criteria in patients with CS in real-world settings in Japan.
METHODS: This is a multicenter, prospective, observational study that aims to use ICMs to evaluate the proportion, timing, and characteristics of AF detection in patients diagnosed with CS. We will investigate the first detection of AF within the initial 6, 12, and 24 months of follow-up after ICM implantation. Patient characteristics, laboratory data, atrial cardiomyopathy markers, serial magnetic resonance imaging findings at baseline, 6, 12, and 24 months after ICM implantation, electrocardiogram readings, transesophageal echocardiography findings, cognitive status, stroke recurrence, and functional outcomes will be compared between patients with AF and patients without AF. Furthermore, we will obtain additional information regarding the number of AF episodes, duration of cumulative AF episodes, and time of anticoagulation initiation.
RESULTS: Study recruitment began in February 2020, and thus far, 213 patients have provided written informed consent and are currently in the follow-up phase. The last recruited participant (May 2021) will have completed the 24-month follow-up in May 2023. The main results are expected to be submitted for publication in 2023.
CONCLUSIONS: The findings of this study will help identify AF markers and generate a risk scoring system with a novel and superior screening algorithm for occult AF detection while identifying candidates for ICM implantation and aiding the development of diagnostic criteria for CS in Japan.
BACKGROUND: UMIN Clinical Trial Registry UMIN000039809; https://tinyurl.com/3jaewe6a.
UNASSIGNED: DERR1-10.2196/39307.
摘要：
背景：阵发性心房颤动（AF）是隐源性卒中（CS）的可能原因，它的检测和治疗对于中风的二级预防很重要。插入式心脏监测仪（ICM）在临床上可有效筛查AF，并且优于常规的短期心脏监测。日本确定CS中ICM临床适应症的指南比西方国家严格。日本和西方指南之间的差异可能会影响CS患者通过ICM对AF的检出率和预测。日本患者的现有数据仅限于小型回顾性研究。此外，有关AF检测的其他信息，包括剧集的数量，累计发作持续时间,抗凝开始（方案的类型和剂量以及开始时间），导管消融率,心房心肌病的作用，和中风复发（复发时间和复发事件的原因），在绝大多数以前发表的研究中都没有提供。
目的：在本研究中，我们旨在确定日本真实世界中CS患者房颤检测的比例和时机以及危险分层标准.
方法：这是一个多中心，prospective,旨在使用ICM评估比例的观察性研究，定时,诊断为CS的患者的房颤检测特征。我们将研究在ICM植入后的最初6、12和24个月内首次检测到AF。患者特征,实验室数据,心房心肌病标志物，基线时的串行磁共振成像结果，ICM植入后6、12和24个月，心电图读数,经食管超声心动图检查结果，认知状态，中风复发,房颤患者和无房颤患者的功能结局将进行比较。此外，我们将获得有关AF发作次数的更多信息，累积AF发作的持续时间,抗凝开始的时间。
结果：研究招募于2020年2月开始，到目前为止，213名患者提供了书面知情同意书，目前处于随访阶段。最后招募的参与者（2021年5月）将于2023年5月完成24个月的随访。主要结果预计将于2023年提交发布。
结论：这项研究的结果将有助于确定房颤标志物，并产生一个风险评分系统，该系统具有新颖且优越的隐匿性房颤检测筛选算法，同时确定ICM植入的候选者，并有助于制定日本的CS诊断标准。
背景：UMIN临床试验注册中心UMIN000039809;https://tinyurl.com/3jaewe6a。
■DERR1-10.2196/39307。
目的：在本研究中，我们旨在确定日本真实世界中CS患者房颤检测的比例和时机以及危险分层标准.
方法：这是一个多中心，prospective,旨在使用ICM评估比例的观察性研究，定时,诊断为CS的患者的房颤检测特征。我们将研究在ICM植入后的最初6、12和24个月内首次检测到AF。患者特征,实验室数据,心房心肌病标志物，基线时的串行磁共振成像结果，ICM植入后6、12和24个月，心电图读数,经食管超声心动图检查结果，认知状态，中风复发,房颤患者和无房颤患者的功能结局将进行比较。此外，我们将获得有关AF发作次数的更多信息，累积AF发作的持续时间,抗凝开始的时间。
结果：研究招募于2020年2月开始，到目前为止，213名患者提供了书面知情同意书，目前处于随访阶段。最后招募的参与者（2021年5月）将于2023年5月完成24个月的随访。主要结果预计将于2023年提交发布。
结论：这项研究的结果将有助于确定房颤标志物，并产生一个风险评分系统，该系统具有新颖且优越的隐匿性房颤检测筛选算法，同时确定ICM植入的候选者，并有助于制定日本的CS诊断标准。
背景：UMIN临床试验注册中心UMIN000039809;https://tinyurl.com/3jaewe6a。
■DERR1-10.2196/39307。
