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Stroke Alarm Efficacy Trial

Study acronym: StrokeAlarmEFF
StatusRecruiting
PhaseNot applicable
Started2024-09-05
View on ClinicalTrials.gov ↗

Amendment history

2026-06-29
Study Status, Sponsor/Collaborators, Study Description, Outcome Measures, Contacts/Locations v2
Primary completion date2026-12-31→2027-10-31
Completion date2026-12-31→2027-12-31
Study sites5→10
Secondary endpoints+536 characters
Time from onset of stroke with unilateral arm motor deficit until alarm by device. Time from onset of stroke with unilateral arm motor deficit until arrival to first hospital. Number of alarms indicated by the device within 3 hours of onset, in patients with a subsequent clinical diagnosis of stroke [...]
Primary endpoints1 entry, revised
TimeAlarm from device within 3 hours of onset of stroke with unilateral arm motor deficit until alarm by the device.
Study description+327 characters
[...] or atrial fibrillation at the participating hospitals that fullfillfulfill all inclusion critera and no exclusion criteria is asked fo [...] elets, are acceptable. Study population All patients (age ≥ 6050 years) with a recent diagnosis of stroke (ischemic stroke or intracerebral hemorrhage) without arm motor deficits, TIA or atrial fibrillationTIA at the participating hospitals isare candidates for participation in the trial. Patients have to be at increased risk for stroke, defined by ABCD2 score of ≥6 (TIA), presence of large artery atherosclerosis or atrial fibrillation (TIA and/or ischemic stro [...] [...]
Collaborators4 to 8 entries
Hässleholm Hospital Uppsala University Hospital Helsingborgs Hospital University Hospital, Linkoeping
2024-12-01
Not Yet Recruiting→Recruiting Study Status, Sponsor/Collaborators, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2025-12-31→2026-12-31
Completion date2026-06-30→2026-12-31
Start dateestimated 2024-05-01→confirmed 2024-09-05
Study sites1→5
Eligibility criteria+229 characters
InclusionINCLUSION Criteria:CRITERIA Age 6050 years or older Modified Rankin scale of 0-2. Diagnosed with either: A. Recent (within 2 weeks)* transient ischemic attack (TIA, G45.9), AND: ABCD2 score of ≥6, OR: Atrial fibrillation AND/OR significant: Large artery stenosis in the symptomatic vessel territoryatherosclerosis**. B. Recent (within 2 weeks)* acute ischemic stroke (I63), AND: 1.• Atrial fibrillation, AND/OR significant: Large artery stenosis in the symptomatic vessel territoryatherosclerosis**. C. Atrial fibrillation/flutter (I48), AND None, 1. Noor reduced dose of, oral anticoagulati [...] [...]
Collaborators+121 characters
Karolinska University Hospital Stockholm South General Hospital Sahlgrenska University Hospital Skane University Hospital
2024-03-11
Original filing
Region Skane
146 trials monitored
See 5 trials at risk
Stroke
3,268 trials monitored
See 122 trials at risk
Atrial Fibrillation
1,126 trials monitored
See 49 trials at risk
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 with an ABCD2 score of ≥6, large artery atherosclerosis or atrial fibrillation, OR 2. recent ischemic stroke with large artery atherosclerosis or atrial fibrillation, without persisting arm motor deficit, OR 3. atrial fibrillation with an CHA2DS2-Vasc score ≥ 4 without adequate anticoagulation OR 4. recent hemorrhagic stroke with atrial fibrillation, without persisting arm motor deficit 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. A control population matched for calendar year, age (± 5 years), sex, healthcare region, baseline stroke severity according to the National Institutes of Health Stroke Scale (NIHSS, ± 5 points), unilateral arm motor deficit (NIHSS item 5a/5b 1-4), presence of neglect/inattention (NIHSS item 11 1-2), atrial fibrillation, cohabitation status and pre-stroke functional level twill be identified in the Swedish national stroke registry, Riksstroke, and used for comparison.
Trial Details
NCT Number NCT06315192
Lead Sponsor Region Skane
Collaborators: Karolinska University Hospital, Stockholm South General Hospital, Sahlgrenska University Hospital, Skane University Hospital, Hässleholm Hospital, Uppsala University Hospital, Helsingborgs Hospital, University Hospital, Linkoeping
Conditions Stroke Acute, Atrial Fibrillation, TIA
Enrollment 500 participants
Start Date 2024-09-05
Primary Completion 2027-10-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-30