Clinical trial NCT04624646: Clinical Implication of Atrial Fibrillation Detection Using Wearable Device in Patients With Cryptogenic Stroke
Official title: Clinical Implication of Atrial Fibrillation Detection Using Wearable Device in Patients With Cryptogenic Stroke - The Comparison Between Short-term Continuous Patch and Long-term Discontinuous Monitoring
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Ischemic Stroke
Transient Ischemic Attack
Keywords: Atrial fibrillation
Ischemic Stroke
Transient Ischemic Attack
Lead sponsor: Ewha Womans University Mokdong Hospital
Sponsor class: OTHER
Collaborators: name: Korea Health Industry Development Institute
First posted: 2020-11-12
Enrollment: 600
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: It is known that atrial fibrillation after stroke significantly increases the risk of stroke or systemic embolism. Accordingly, efforts have been made to detect hidden atrial fibrillation and apply treatment using anticoagulants instead of antiplatelet agents. The conventional method used to screen for atrial fibrillation in stroke patients who did not have atrial fibrillation at first admission is 24-hour Holter monitoring. This study will compare the detection rate of atrial fibrillation with discontinuous ECG monitoring three times a day and 72 hours of single-lead ECG patch monitoring compared with the conventional Holter test.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed brain infarction
* No history and diagnosis of atrial fibrillation at the time of admission
* Rejected implantable loop recorder
* Informed consent

Exclusion Criteria:

* Cannot use KardiaMobile system alone or with the help of others

Primary outcomes:
measure: Atrial fibrillation detection rate
timeFrame: Until 1 year after stroke
Secondary outcomes:
measure: Recurrent stroke
timeFrame: Until 1 year after stroke
measure: Major adverse cardiac and cerebrovascular event
timeFrame: Until 1 year after stroke
Other outcomes:
Locations:
city: Yongin
country: Korea, Republic of
facility: Yonsei University Health System, Yongin Severance Hospital
state: Gyeonggi-do
city: Gangseo
country: Korea, Republic of
facility: Ewha Womans University Seoul Hospital
state: Seoul
city: Seongdong
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
state: Seoul
city: Yangcheon
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
state: Seoul
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Ewha Womans University Mokdong Hospital
name: Junbeom Park, M.D., PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ewha Womans University Seoul Hospital
name: Tae-Jin Song, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ewha Womans University Seoul Hospital
name: Dong-Hyeok Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: