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. 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. 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. (cris.nih.go.kr KCT0005592).
Bibliographical noteFunding Information:
This research was supported by the Basic Science Research Program funded through the National Research Foundation of Korea (NRF) by the Ministry of Science, ICT & Future Planning [Grant Number: NRF-2017R1E1A1A01078382] as well as the Korea Medical Device Development Fund grant funded by the Korean government [Grant Numbers: 9991006899, KMDF_PR_20200901_0234, NTIS, KMDF-RnD 202014X28-00]. One hundred single-lead type recorders (cost: ~USD 10,000) were donated by the manufacturer.
Copyright © 2022 Jung, Lee, Kang, Shin, Chang, Woo Shin, Park, Kim, Nam, Heo, Kim, Yu, Lee, Heo, Woo, Park, Roh, Kim, Lee, Do, Kim, Song, Park and CANDLE-AF Trial Investigators.
- atrial fibrillation
- cryptogenic stroke
- ischemic stroke
- rhythm monitoring
- single-lead ECG
- wearable device