Wearable device to detect stroke onset

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of the Stroke Alarm, a CE-marked wearable device, in identifying the onset of stroke characterized by unilateral arm motor deficit within three hours. It is a multicenter, prospective observational trial involving 500 patients who will wear the device continuously for three months. Data will be collected at baseline, three months post-inclusion, and through national registry data to assess the device's performance in detecting stroke events. The study will also include a propensity-matched control group for comparison.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sahlgrenska University Hospital
  Gothenburg, Sweden Recruiting
• Hässleholms sjukhus
  Hässleholm, Sweden Recruiting
• Helsingborg lasarett
  Helsingborg, Sweden Recruiting
• Karolinska University Hospital Huddinge
  Huddinge, Sweden Recruiting
• Linköping university hospital
  Linköping, Sweden Recruiting
• Skane University hospital
  Lund, Sweden Recruiting

Study contacts

• Study coordinator: Magnus Esbjörnsson, MD
• Email: magnus.esbjornsson@skane.se
• Phone: 800-555-5555

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• AI-based tools to help diagnose, treat and predict stroke outcomes across multiple hospitals

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.