Accepted for/Published in: JMIR Research Protocols
Date Submitted: May 8, 2022
Open Peer Review Period: May 8, 2022 - Jul 3, 2022
Date Accepted: Jan 24, 2023
(closed for review but you can still tweet)
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
ABSTRACT
Background:
Paroxysmal atrial fibrillation (AF) is a probable cause of cryptogenic stroke (CS), and AF 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. However, the available data are primarily derived from small retrospective studies within Asian cohorts, and detailed analyses of differences in patient characteristics with and without AF are lacking.
Objective:
In this study, we aim to identify the incidence of AF detection and risk stratification criteria in Japan.
Methods:
This study 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, 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 and without AF.
Results:
Study recruitment began in February 2020, and thus far, 213 patients have provided written informed consent and are currently under follow-up phase. Final results are expected in May 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. Clinical Trial: UMIN Clinical Trial Registry (ID: UMIN000039809); https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044853
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