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. 2022 Apr 4:9:837958.
doi: 10.3389/fcvm.2022.837958. eCollection 2022.

Clinical Implications of Atrial Fibrillation Detection Using Wearable Devices in Patients With Cryptogenic Stroke (CANDLE-AF) Trial: Design and Rationale

Sodam Jung  1 , Hye Ah Lee  2 , In Sook Kang  1 , Sang Hoon Shin  3 , Yoonkyung Chang  1 , Dong Woo Shin  4 , Moo-Seok Park  5 , Young Dae Kim  6 , Hyo Suk Nam  6 , Ji Hoe Heo  6 , Tae-Hoon Kim  7 , Hee Tae Yu  7 , Jung Myung Lee  8 , Sung Hyuk Heo  9 , Ho Geol Woo  9 , Jin-Kyu Park  10 , Seung-Young Roh  11 , Chi Kyung Kim  12 , Young-Soo Lee  13 , Jin Kuk Do  14 , Dong-Hyeok Kim  3 , Tae-Jin Song  5 , Junbeom Park  1 ; CANDLE-AF Trial Investigators
Affiliations

Clinical Implications of Atrial Fibrillation Detection Using Wearable Devices in Patients With Cryptogenic Stroke (CANDLE-AF) Trial: Design and Rationale

Sodam Jung et al. Front Cardiovasc Med. .

Erratum in

Abstract

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).

Keywords: atrial fibrillation; cryptogenic stroke; ischemic stroke; rhythm monitoring; single-lead ECG; wearable device.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Flow chart of the study design. AF, atrial fibrillation; TIA, transient ischemic attack; MACCE, major adverse cardiovascular and cerebrovascular events (composite of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death).
Figure 2
Figure 2
Two types of wearable devices in this study. (A) Single-lead ECG monitor (mobiCARE-MC100 TM) which is attached by replaceable adhesive ECG electrodes, (A) Single-lead event recorder type monitor (KardiaMobile systemTM) being used with finger of right and left hand touching the respective electrode and showing sample ECG rhythm in mobile phone display. Copyright with permission from Seers Technology (A) and Alivecor (B).
See this image and copyright information in PMC

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