StrokeAlarm Trial 2

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Sweden
Hässleholms sjukhus
RECRUITING
Hässleholm
Contact Information
Primary
Johan Wasselius, MD, PhD
johan.wasselius@med.lu.se
+4646173082
Backup
Åke Holmberg, MSc
ake.holmberg@reegionstockholm.se
Time Frame
Start Date: 2022-01-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 200
Treatments
Experimental: StrokeAlarm use
This is a single arm study. All participants will be instructed to use the StrokeAlarm medical device for 1 month.
Related Therapeutic Areas
Sponsors
Leads: Region Skane

This content was sourced from clinicaltrials.gov