Clinical Implications of Atrial Fibrillation Detection Using Wearable Devices in Patients With Cryptogenic Stroke (CANDLE-AF) Trial: Design and Rationale
- 주제(키워드) atrial fibrillation , wearable device , single-lead ECG , rhythm monitoring , ischemic stroke , cryptogenic stroke
- 주제(기타) Cardiac & Cardiovascular Systems
- 설명문(일반) [Jung, Sodam; Kang, In Sook; Chang, Yoonkyung; Park, Junbeom] Ewha Womans Univ Mokdong Hosp, Div Cardiol, Seoul, South Korea; [Lee, Hye Ah] Ewha Womans Univ Mokdong Hosp, Clin Trial Ctr, Seoul, South Korea; [Shin, Sang Hoon; Kim, Dong-Hyeok] Ewha Womans Univ, Seoul Hosp, Div Cardiol, Seoul, South Korea; [Woo Shin, Dong] Ewha Womans Univ Mokdong Hosp, Dept Neurol, Seoul, South Korea; [Park, Moo-Seok; Song, Tae-Jin] Ewha Womans Univ, Seoul Hosp, Dept Neurol, Seoul, South Korea; [Kim, Young Dae; Nam, Hyo Suk; Heo, Ji Hoe] Yonsei Univ, Coll Med, Dept Neurol, Seoul, South Korea; [Kim, Tae-Hoon; Yu, Hee Tae] Severance Cardiovasc Hosp, Div Cardiol, Seoul, South Korea; [Lee, Jung Myung] Kyung Hee Univ Hosp, Div Cardiol, Seoul, South Korea; [Heo, Sung Hyuk; Woo, Ho Geol] Kyung Hee Univ Hosp, Dept Neurol, Seoul, South Korea; [Park, Jin-Kyu] Hanyang Univ, Seoul Hosp, Div Cardiol, Seoul, South Korea; [Roh, Seung-Young] Korea Univ, Guro Hosp, Devis Cardiol, Seoul, South Korea; [Kim, Chi Kyung] Korea Univ, Guro Hosp, Dept Neurol, Seoul, South Korea; [Lee, Young-Soo] Daegu Catholic Univ, Med Ctr, Div Cardiol, Daegu, South Korea; [Do, Jin Kuk] Daegu Catholic Univ, Med Ctr, Dept Neurol, Daegu, South Korea
- 등재 SCIE, SCOPUS
- OA유형 Green Published, gold
- 발행기관 FRONTIERS MEDIA SA
- 발행년도 2022
- 총서유형 Journal
- URI http://www.dcollection.net/handler/ewha/000000190894
- 본문언어 영어
- Published As https://doi.org/10.3389/fcvm.2022.837958
- PubMed https://pubmed.ncbi.nlm.nih.gov/35445088
초록/요약
Background: Although many electrocardiography wearable devices have been released recently for the detection of atrial fibrillation (AF), there are few studies reporting prospective data for wearable devices compared to the strategy of the existing guidelines in the detection of atrial fibrillation (AF) after cryptogenic stroke. A tiny single-patch monitor is more convenient than a conventional Holter monitor recording device and, therefore, longer duration of monitoring may be acceptable.& nbsp;& nbsp;Methods and Design: The CANDLE-AF study is a multicenter, prospective, randomized controlled trial. Patients with transient ischemic attack or ischemic stroke without any history of AF will be enrolled. The superiority of the 72-h single-patch monitor to standard strategy and non-inferiority of the 72-h single-patch monitor to an event-recorder-type device will be investigated. Single-patch monitor arm will repeat monitoring at 1, 3, 6, and 12 months, event-recorder-type arm will repeat monitoring twice daily for 12 months. The enrollment goal is a total of 600 patients, and the primary outcome is the detection of AF which continues at least 30 s during study period. The secondary outcome is the rate of changes from antiplatelet to anticoagulant and major adverse cardiac and cerebrovascular events within 1 year.& nbsp;Conclusions: The results of CANDLE-AF will clarify the role of a single-lead patch ECG for the early detection of AF in patients with acute ischemic stroke. In addition, the secondary outcome will be analyzed to determine whether more sensitive AF detection can affect the prognosis and if further device development is meaningful. ( KCT0005592).
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