StrokeAlarm Trial 2

Launched by REGION SKANE · Dec 2, 2021

Keywords

ClinConnect Summary

The StrokeAlarm Trial 2 is a research study looking at a new wearable device called the Stroke Alarm, designed to help identify strokes in people who have recently experienced a transient ischemic attack (TIA), a minor stroke, or have a heart condition called atrial fibrillation. This study will take place in multiple locations and is open to adults aged 18 and older who meet specific health criteria, such as having been diagnosed with a TIA, a minor stroke with good arm movement, or atrial fibrillation at risk for stroke. The goal is to see how well this device works for patients in real life.

If you or a family member are interested in participating, you should know that you'll need to be able to give consent and speak either Swedish or English. Participants will wear the device and use a smartphone app to track their health. The study will assess how usable and helpful this system is for people at risk of stroke. Additionally, you'll need a compatible smartphone during the study. Overall, the trial aims to improve how we can prevent and respond to strokes in patients who need it most.

Gender

ALL

Eligibility criteria

• 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.