Stroke Alarm Efficacy Trial
Recruiting · NCT06315192 · Interventional (participants receive a specific treatment) · Lead sponsor: Region Skane
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- Previous inclusion in this study.
- Arm motor deficit from any previous medical condition.
- Unable to give informed consent to participate in the study.
- Does not master any of the languages available within the Stroke Alarm smartphone app in speech and writing.
- Does not have access to a Stroke Alarm compatible smartphone.
- Deemed unable to handle the Stroke Alarm smartphone app, or participate in planned follow-up within the framework of the study due to other diseases or circumstances.
- Does not want to participate.
Where it is running
10 locations listed.
- Sahlgrenska University Hospital - Gothenburg, Sweden
- Helsingborg lasarett - Helsingborg, Sweden
- Karolinska University Hospital Huddinge - Huddinge, Sweden
- Hässleholms sjukhus - Hässleholm, Sweden
- Linköping university hospital - Linköping, Sweden
- Skane University hospital - Lund, Sweden
- Skåne University Hospital Malmö - Malmö, Sweden
- Karolinska Sjukhuset - Stockholm, Sweden
- Södersjukhuset - Stockholm, Sweden
- Uppsala University hospital - Uppsala, Sweden