| NCT ID | NCT06315192 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Region Skane |
| Condition | Stroke Acute |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2024-09-05 |
| Primary Completion | 2027-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 500 participants in total. It began in 2024-09-05 with a primary completion date of 2027-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
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.
Contact & Investigator
Ulrika Anderson, Ms.
STUDY DIRECTOR
Lund University
Frequently Asked Questions
Who can join the NCT06315192 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06315192 currently recruiting?
Yes, NCT06315192 is actively recruiting participants. Contact the research team at magnus.esbjornsson@skane.se for enrollment information.
Where is the NCT06315192 trial being conducted?
This trial is being conducted at Gothenburg, Sweden, Hässleholm, Sweden, Helsingborg, Sweden, Huddinge, Sweden and 6 additional locations.
Who is sponsoring the NCT06315192 clinical trial?
NCT06315192 is sponsored by Region Skane. The principal investigator is Ulrika Anderson, Ms. at Lund University. The trial plans to enroll 500 participants.
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