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. 2023 Apr 13:12:e39307.
doi: 10.2196/39307.

Detection of Atrial Fibrillation Using Insertable Cardiac Monitors in Patients With Cryptogenic Stroke in Japan (the LOOK Study): Protocol for a Prospective Multicenter Observational Study

Satoshi Suda  1 , Takehiro Katano  1 , Kazuo Kitagawa  2 , Yasuyuki Iguchi  3 , Shigeru Fujimoto  4 , Kenjiro Ono  5 , Osamu Kano  6 , Hidehiro Takekawa  7 , Masatoshi Koga  8 , Masafumi Ihara  9 , Masafumi Morimoto  10 , Hiroshi Yamagami  11 , Tadashi Terasaki  12 , Keiji Yamaguchi  13 , Seiji Okubo  14 , Yuji Ueno  15 , Nobuyuki Ohara  16 , Yuki Kamiya  17 , Masataka Takeuchi  18 , Yukako Yazawa  19 , Yuka Terasawa  20 , Ryosuke Doijiri  21 , Yoshifumi Tsuboi  22 , Kazutaka Sonoda  23 , Koichi Nomura  24 , Takashi Shimoyama  25 , Akihito Kutsuna  25 , Kazumi Kimura  1
Affiliations

Detection of Atrial Fibrillation Using Insertable Cardiac Monitors in Patients With Cryptogenic Stroke in Japan (the LOOK Study): Protocol for a Prospective Multicenter Observational Study

Satoshi Suda et al. JMIR Res Protoc. .

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.

Trial registration: UMIN Clinical Trial Registry UMIN000039809; https://tinyurl.com/3jaewe6a.

International registered report identifier (irrid): DERR1-10.2196/39307.

Keywords: atrial cardiomyopathy; atrial fibrillation; biomarker; cryptogenic stroke; insertable cardiac monitor.

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Conflict of interest statement

Conflicts of Interest: SS reports research funding from the All Japan Coffee Association and Pfizer Co, Ltd, and lecture fees from EISAI Co, Ltd. K Kitagawa reports lecture fees from Daiichi Sankyo Co, Ltd and Kyowa Kirin Co, Ltd, and received research funding from Daiichi Sankyo Co, Ltd. YI reports lecture fees from Bayer Healthcare Co, Ltd, Pfizer Japan Inc, Nippon Boehringer Ingelheim Co, Ltd, Takeda Pharmaceutical Co, Ltd, Otsuka Pharmaceutical Co, Ltd, and Daiichi Sankyo Co, Ltd, outside of the submitted work and research funding from Sanofi Co, Ltd. SF reports lecture fees from Takeda Pharmaceutical Co, Ltd, Bayer Yakuhin Co, Ltd, Otsuka Pharmaceutical Co, Ltd, Bristol-Myers Squibb Co, Ltd, Pfizer Co, Ltd, and Daiichi Sankyo Co, Ltd. KO reports lecture fees from Daiichi Sankyo Co, Ltd. HT received lecture fees from Pfizer Co, Ltd and Daiichi Sankyo Co, Ltd. MK reports research funding from Daiichi Sankyo Co, Ltd and Nippon Boehringer Ingelheim Co, Ltd. MI reports lecture fees from Daiichi Sankyo and EISAI, and grant support from Panasonic, GE Precision Healthcare LLC, Bristol-Myers Squibb, and Shimadzu Corporation. HY reports lecture fees from Stryker Co, Ltd, Bayer Yakuhin Co, Ltd, and Daiichi Sankyo Co, Ltd, and research funding from Bristol-Myers Squibb Co, Ltd. KY reports lecture fees from Daiichi Sankyo Co, Ltd. YU received lecture fees from OHARA Pharmaceutical Co, Ltd, and research funds from Bristol-Myers Squibb. YK reports lecture fees from Daiichi Sankyo Co, Ltd. Bayer Healthcare Co, Ltd, and Medtronic Japan Co, Ltd, and research funding and remuneration from Bristol-Myers Squibb Co, Ltd and Nippon Boehringer Ingelheim Co, Ltd. K Kimura reports lecture fees from Bristol-Myers Squibb Co, Ltd, Nippon Boehringer Ingelheim Co, Ltd, Bayer Healthcare Co, Ltd, and Daiichi Sankyo Co, Ltd, and research funding from Teijin Pharma Co, Ltd, Nippon Boehringer Ingelheim Co, Ltd, and Daiichi Sankyo Co, Ltd.

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