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StrokeAlarm Trial 2

RECRUITINGN/ASponsored by Region Skane
Actively Recruiting
PhaseN/A
SponsorRegion Skane
Started2022-01-01
Est. completion2025-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted

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

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

1. Age 18 years or older
2. 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.
3. Subject has after study specific information consent to participation by signing the Ethics committee-approved inform consent form.

Exclusion Criteria:

1. Already included in the study in connection with previous TIA/stroke.
2. Has an affected arm function due to previous stroke or other illness/trauma.
3. Cannot provide informed consent to participation in the study.
4. Does not speak Swedish or English in speech and writing.
5. Assessed due to other diseases or circumstances in general cannot contribute to planned follow-up within the framework of the study.
6. Do not want to participate.
7. During the study period, do not have access to a compatible smartPhone.
8. Not deemed capable of managing the Stroke Alarm smartphone app.

Conditions4

Atrial FibrillationHeart DiseaseStrokeTIA

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