Stroke Alarm Efficacy Trial

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The aim of this study is to test the efficacy of the CE-marked wearable system Stroke Alarm to identify the onset of a stroke with unilateral arm motor deficit within 3 hours of onset. This is a multicenter, prospective observational single-arm trial with a registry-based propensity matched control population. A total of 500 patients will be included in the trial. An interim analysis will determine if the stroke onset frequency is sufficient to determine the main outcome. Should the number of stroke events differ from what is expected at interim analysis, study enrollment will continue to increase cohort size. Patients who meet the criteria for participation will, after signing consent, be included and receive the Stroke Alarm bracelets that are used for 3 months. Study data will be collected as baseline at inclusion, at follow-up 3 months after inclusion and by using national Swedish registry data after completion of the study. Patients with elevated stroke risk according assessed by presence of specific criteria associated with elevated risk caused by: 1. recent TIA, OR 2. recent stroke without persisting arm motor deficit, OR 3. atrial fibrillation A control population matched for age, sex, NIHSS score and health care region will be identified in the Swedish national stroke registry, Riksstroke, and used for comparison. The combined efficacy goal is at least 60% sensitivity for Stroke Alarm b of stroke with unilateral arm motor deficit within 3 hours of onset (with a 95% confidence interval above 30%) and a specificity of at least 80% using a clinical stroke diagnosis as gold standard.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age 50 years or older

• Modified Rankin scale of 0-2.

• Diagnosed with either:

• A. Recent\* transient ischemic attack (TIA, G45.9), AND:

⁃ ABCD2 score of ≥6, OR:

⁃ Atrial fibrillation OR:

⁃ Large artery atherosclerosis\*\*.

• B. Recent\* acute ischemic stroke (I63), AND:

• • Atrial fibrillation, OR:

⁃ Large artery atherosclerosis\*\*. C. Atrial fibrillation/flutter (I48), AND

⁃ None, or reduced dose of, oral anticoagulation medication\*\*\*, AND

⁃ CHA2DS2-VASC score ≥4.

• D. Recent\* intracerebral hemorrhage (I61.9), AND:

• • Atrial fibrillation.

• The patient has received the required information about the study and agrees in writing to participate.

• Smartphone user since at least 1 year.

‣ Within the last 2 weeks \*\*Atherosclerosis in carotid, vertebral aortic arch or major intracerebral arteries according to CTA or ultrasound.

∙ Including all oral anticoagulation medication such as Warfarin and NOACs. Patients with reduced dose of a NOAC can be included, regardless if this is within the approved label, or if reduced dose is chosen off-label for other reasons. Treatment with antiplatelet medication is permissible.

Locations
Other Locations
Sweden
Sahlgrenska University Hospital
NOT_YET_RECRUITING
Gothenburg
Hässleholms sjukhus
RECRUITING
Hässleholm
Karolinska University Hospital Huddinge
NOT_YET_RECRUITING
Huddinge
Skane University hospital
RECRUITING
Lund
Skåne University Hospital Malmö
RECRUITING
Malmo
Contact Information
Primary
Magnus Esbjörnsson, MD
magnus.esbjornsson@skane.se
800-555-5555
Backup
Johan Wasselius, MD, PhD
johan.wasselius@gmail.com
800-555-5555
Time Frame
Start Date: 2024-09-05
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 500
Treatments
Experimental: Stroke Alarm use
The patients are provided with Stroke Alarm and instructed to use it in accordance with the IFU for a 3 months period.
Related Therapeutic Areas
Sponsors
Collaborators: Stockholm South General Hospital, Karolinska University Hospital, Sahlgrenska University Hospital, Skane University Hospital
Leads: Region Skane

This content was sourced from clinicaltrials.gov