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
BackgroundParoxysmal 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...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
JMIR Publications
2023-04-01
|
| Series: | JMIR Research Protocols |
| Online Access: | https://www.researchprotocols.org/2023/1/e39307 |
| _version_ | 1827857448371748864 |
|---|---|
| author | Satoshi Suda Takehiro Katano Kazuo Kitagawa Yasuyuki Iguchi Shigeru Fujimoto Kenjiro Ono Osamu Kano Hidehiro Takekawa Masatoshi Koga Masafumi Ihara Masafumi Morimoto Hiroshi Yamagami Tadashi Terasaki Keiji Yamaguchi Seiji Okubo Yuji Ueno Nobuyuki Ohara Yuki Kamiya Masataka Takeuchi Yukako Yazawa Yuka Terasawa Ryosuke Doijiri Yoshifumi Tsuboi Kazutaka Sonoda Koichi Nomura Takashi Shimoyama Akihito Kutsuna Kazumi Kimura |
| author_facet | Satoshi Suda Takehiro Katano Kazuo Kitagawa Yasuyuki Iguchi Shigeru Fujimoto Kenjiro Ono Osamu Kano Hidehiro Takekawa Masatoshi Koga Masafumi Ihara Masafumi Morimoto Hiroshi Yamagami Tadashi Terasaki Keiji Yamaguchi Seiji Okubo Yuji Ueno Nobuyuki Ohara Yuki Kamiya Masataka Takeuchi Yukako Yazawa Yuka Terasawa Ryosuke Doijiri Yoshifumi Tsuboi Kazutaka Sonoda Koichi Nomura Takashi Shimoyama Akihito Kutsuna Kazumi Kimura |
| author_sort | Satoshi Suda |
| collection | DOAJ |
| description |
BackgroundParoxysmal 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.
ObjectiveIn 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.
MethodsThis 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.
ResultsStudy 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.
ConclusionsThe 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 RegistrationUMIN Clinical Trial Registry UMIN000039809; https://tinyurl.com/3jaewe6a
International Registered Report Identifier (IRRID)DERR1-10.2196/39307 |
| first_indexed | 2024-03-12T12:40:41Z |
| format | Article |
| id | doaj.art-b66479d29e3c483392ed77958a93196f |
| institution | Directory Open Access Journal |
| issn | 1929-0748 |
| language | English |
| last_indexed | 2024-03-12T12:40:41Z |
| publishDate | 2023-04-01 |
| publisher | JMIR Publications |
| record_format | Article |
| series | JMIR Research Protocols |
| spelling | doaj.art-b66479d29e3c483392ed77958a93196f2023-08-28T23:52:46ZengJMIR PublicationsJMIR Research Protocols1929-07482023-04-0112e3930710.2196/39307Detection of Atrial Fibrillation Using Insertable Cardiac Monitors in Patients With Cryptogenic Stroke in Japan (the LOOK Study): Protocol for a Prospective Multicenter Observational StudySatoshi Sudahttps://orcid.org/0000-0002-7242-2005Takehiro Katanohttps://orcid.org/0000-0002-8176-0938Kazuo Kitagawahttps://orcid.org/0000-0002-7669-231XYasuyuki Iguchihttps://orcid.org/0000-0002-6662-0611Shigeru Fujimotohttps://orcid.org/0000-0003-4564-7396Kenjiro Onohttps://orcid.org/0000-0001-8454-6155Osamu Kanohttps://orcid.org/0000-0003-3748-3694Hidehiro Takekawahttps://orcid.org/0000-0002-9653-5266Masatoshi Kogahttps://orcid.org/0000-0002-6758-4026Masafumi Iharahttps://orcid.org/0000-0002-7102-4048Masafumi Morimotohttps://orcid.org/0000-0002-4390-2472Hiroshi Yamagamihttps://orcid.org/0000-0001-8133-3314Tadashi Terasakihttps://orcid.org/0000-0001-5379-5933Keiji Yamaguchihttps://orcid.org/0000-0003-4763-4599Seiji Okubohttps://orcid.org/0000-0003-0789-242XYuji Uenohttps://orcid.org/0000-0002-8617-3695Nobuyuki Oharahttps://orcid.org/0000-0003-4033-9183Yuki Kamiyahttps://orcid.org/0000-0003-3528-6953Masataka Takeuchihttps://orcid.org/0000-0003-1820-1786Yukako Yazawahttps://orcid.org/0000-0003-3891-0221Yuka Terasawahttps://orcid.org/0000-0002-3704-7369Ryosuke Doijirihttps://orcid.org/0000-0002-2830-9232Yoshifumi Tsuboihttps://orcid.org/0000-0001-7596-9594Kazutaka Sonodahttps://orcid.org/0000-0002-1406-1336Koichi Nomurahttps://orcid.org/0000-0002-6392-3684Takashi Shimoyamahttps://orcid.org/0000-0002-8194-3996Akihito Kutsunahttps://orcid.org/0000-0001-7282-3581Kazumi Kimurahttps://orcid.org/0000-0003-2386-5528 BackgroundParoxysmal 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. ObjectiveIn 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. MethodsThis 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. ResultsStudy 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. ConclusionsThe 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 RegistrationUMIN Clinical Trial Registry UMIN000039809; https://tinyurl.com/3jaewe6a International Registered Report Identifier (IRRID)DERR1-10.2196/39307https://www.researchprotocols.org/2023/1/e39307 |
| spellingShingle | Satoshi Suda Takehiro Katano Kazuo Kitagawa Yasuyuki Iguchi Shigeru Fujimoto Kenjiro Ono Osamu Kano Hidehiro Takekawa Masatoshi Koga Masafumi Ihara Masafumi Morimoto Hiroshi Yamagami Tadashi Terasaki Keiji Yamaguchi Seiji Okubo Yuji Ueno Nobuyuki Ohara Yuki Kamiya Masataka Takeuchi Yukako Yazawa Yuka Terasawa Ryosuke Doijiri Yoshifumi Tsuboi Kazutaka Sonoda Koichi Nomura Takashi Shimoyama Akihito Kutsuna Kazumi Kimura 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 JMIR Research Protocols |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://www.researchprotocols.org/2023/1/e39307 |
| work_keys_str_mv | AT satoshisuda detectionofatrialfibrillationusinginsertablecardiacmonitorsinpatientswithcryptogenicstrokeinjapanthelookstudyprotocolforaprospectivemulticenterobservationalstudy AT takehirokatano detectionofatrialfibrillationusinginsertablecardiacmonitorsinpatientswithcryptogenicstrokeinjapanthelookstudyprotocolforaprospectivemulticenterobservationalstudy AT kazuokitagawa detectionofatrialfibrillationusinginsertablecardiacmonitorsinpatientswithcryptogenicstrokeinjapanthelookstudyprotocolforaprospectivemulticenterobservationalstudy AT yasuyukiiguchi detectionofatrialfibrillationusinginsertablecardiacmonitorsinpatientswithcryptogenicstrokeinjapanthelookstudyprotocolforaprospectivemulticenterobservationalstudy AT shigerufujimoto detectionofatrialfibrillationusinginsertablecardiacmonitorsinpatientswithcryptogenicstrokeinjapanthelookstudyprotocolforaprospectivemulticenterobservationalstudy AT kenjiroono detectionofatrialfibrillationusinginsertablecardiacmonitorsinpatientswithcryptogenicstrokeinjapanthelookstudyprotocolforaprospectivemulticenterobservationalstudy AT osamukano detectionofatrialfibrillationusinginsertablecardiacmonitorsinpatientswithcryptogenicstrokeinjapanthelookstudyprotocolforaprospectivemulticenterobservationalstudy AT hidehirotakekawa detectionofatrialfibrillationusinginsertablecardiacmonitorsinpatientswithcryptogenicstrokeinjapanthelookstudyprotocolforaprospectivemulticenterobservationalstudy AT masatoshikoga detectionofatrialfibrillationusinginsertablecardiacmonitorsinpatientswithcryptogenicstrokeinjapanthelookstudyprotocolforaprospectivemulticenterobservationalstudy AT masafumiihara detectionofatrialfibrillationusinginsertablecardiacmonitorsinpatientswithcryptogenicstrokeinjapanthelookstudyprotocolforaprospectivemulticenterobservationalstudy AT masafumimorimoto detectionofatrialfibrillationusinginsertablecardiacmonitorsinpatientswithcryptogenicstrokeinjapanthelookstudyprotocolforaprospectivemulticenterobservationalstudy AT hiroshiyamagami detectionofatrialfibrillationusinginsertablecardiacmonitorsinpatientswithcryptogenicstrokeinjapanthelookstudyprotocolforaprospectivemulticenterobservationalstudy AT tadashiterasaki detectionofatrialfibrillationusinginsertablecardiacmonitorsinpatientswithcryptogenicstrokeinjapanthelookstudyprotocolforaprospectivemulticenterobservationalstudy AT keijiyamaguchi detectionofatrialfibrillationusinginsertablecardiacmonitorsinpatientswithcryptogenicstrokeinjapanthelookstudyprotocolforaprospectivemulticenterobservationalstudy AT seijiokubo detectionofatrialfibrillationusinginsertablecardiacmonitorsinpatientswithcryptogenicstrokeinjapanthelookstudyprotocolforaprospectivemulticenterobservationalstudy AT yujiueno detectionofatrialfibrillationusinginsertablecardiacmonitorsinpatientswithcryptogenicstrokeinjapanthelookstudyprotocolforaprospectivemulticenterobservationalstudy AT nobuyukiohara detectionofatrialfibrillationusinginsertablecardiacmonitorsinpatientswithcryptogenicstrokeinjapanthelookstudyprotocolforaprospectivemulticenterobservationalstudy AT yukikamiya detectionofatrialfibrillationusinginsertablecardiacmonitorsinpatientswithcryptogenicstrokeinjapanthelookstudyprotocolforaprospectivemulticenterobservationalstudy AT masatakatakeuchi detectionofatrialfibrillationusinginsertablecardiacmonitorsinpatientswithcryptogenicstrokeinjapanthelookstudyprotocolforaprospectivemulticenterobservationalstudy AT yukakoyazawa detectionofatrialfibrillationusinginsertablecardiacmonitorsinpatientswithcryptogenicstrokeinjapanthelookstudyprotocolforaprospectivemulticenterobservationalstudy AT yukaterasawa detectionofatrialfibrillationusinginsertablecardiacmonitorsinpatientswithcryptogenicstrokeinjapanthelookstudyprotocolforaprospectivemulticenterobservationalstudy AT ryosukedoijiri detectionofatrialfibrillationusinginsertablecardiacmonitorsinpatientswithcryptogenicstrokeinjapanthelookstudyprotocolforaprospectivemulticenterobservationalstudy AT yoshifumitsuboi detectionofatrialfibrillationusinginsertablecardiacmonitorsinpatientswithcryptogenicstrokeinjapanthelookstudyprotocolforaprospectivemulticenterobservationalstudy AT kazutakasonoda detectionofatrialfibrillationusinginsertablecardiacmonitorsinpatientswithcryptogenicstrokeinjapanthelookstudyprotocolforaprospectivemulticenterobservationalstudy AT koichinomura detectionofatrialfibrillationusinginsertablecardiacmonitorsinpatientswithcryptogenicstrokeinjapanthelookstudyprotocolforaprospectivemulticenterobservationalstudy AT takashishimoyama detectionofatrialfibrillationusinginsertablecardiacmonitorsinpatientswithcryptogenicstrokeinjapanthelookstudyprotocolforaprospectivemulticenterobservationalstudy AT akihitokutsuna detectionofatrialfibrillationusinginsertablecardiacmonitorsinpatientswithcryptogenicstrokeinjapanthelookstudyprotocolforaprospectivemulticenterobservationalstudy AT kazumikimura detectionofatrialfibrillationusinginsertablecardiacmonitorsinpatientswithcryptogenicstrokeinjapanthelookstudyprotocolforaprospectivemulticenterobservationalstudy |