AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

Stroke Alarm Efficacy Trial

RecruitingNAAges 18 Years - anyAllRegion Skane
💬

In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
INCLUSION CRITERIA 1. Age 50 years or older 2. Modified Rankin scale of 0-2. 3. 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. 4. The patient has received the required information about the study and agrees in writing to participate. 5. 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 1. Previous inclusion in this study. 2. Arm motor deficit from any previous medical condition. 3. Unable to give informed consent to participate in the study. 4. Does not master any of the languages available within the Stroke Alarm smartphone app in speech and writing. 5. Does not have access to a Stroke Alarm compatible smartphone. 6. 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. 7. Does not want to participate.
💊

What it tests

  • Stroke Alarm
📍

Where

10 sites
Sahlgrenska University Hospital
Gothenburg, Sweden
Hässleholms sjukhus
Hässleholm, Sweden
Helsingborg lasarett
Helsingborg, Sweden
Karolinska University Hospital Huddinge
Huddinge, Sweden
Linköping university hospital
Linköping, Sweden
Skane University hospital
Lund, Sweden
Skåne University Hospital Malmö
Malmö, Sweden
Karolinska Sjukhuset
Stockholm, Sweden

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy