RecruitingNot ApplicableNCT05144932
StrokeAlarm Trial 2
Sponsor
Region Skane
Enrollment
200 participants
Start Date
Jan 1, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
This open, multicenter, prospective, singel-arm study will evaluate usability and feasibility of a wearable stroke indication system (Stroke Alarm) in patients with recent TIA, recent minor stroke without persistent arm motor deficit, or atrial fibrillation up to 1 month.
Eligibility
Min Age: 18 Years
Inclusion Criteria3
- Age 18 years or older
- Patients with 2A. Diagnosed (ICD-10) TIA (G45.9: Transitory ischemic attack or G45.3: Amaurosis fugax, or 2B. ICD-10 ischemic stroke, I63.0-9. 2C. Newly diagnosed atrial fibrillation. 2D. Atrial fibrillation with an increased risk of stroke (contraindication to oral anticoagulants, reduced dose of oral anticoagulants or other risk factors presenting an estimated annual stroke risk of 5% or more despite anticoagulants treatment.
- Subject has after study specific information consent to participation by signing the Ethics committee-approved inform consent form.
Exclusion Criteria8
- Already included in the study in connection with previous TIA/stroke.
- Has an affected arm function due to previous stroke or other illness/trauma.
- Cannot provide informed consent to participation in the study.
- Does not speak Swedish or English in speech and writing.
- Assessed due to other diseases or circumstances in general cannot contribute to planned follow-up within the framework of the study.
- Do not want to participate.
- During the study period, do not have access to a compatible smartPhone.
- Not deemed capable of managing the Stroke Alarm smartphone app.
Interventions
DEVICEStroke Alarm
The patients are in this clinical trial instructed to use the device continuously for 1 month.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05144932
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