Stroke Alarm Efficacy Trial

Launched by REGION SKANE · Mar 11, 2024

Keywords

ClinConnect Summary

The Stroke Alarm Efficacy Trial is designed to see how well a special wearable device, called the Stroke Alarm, can detect the early signs of a stroke, particularly when there is weakness in one arm, within three hours of it starting. The study will include 500 participants who are at higher risk of having a stroke, such as those who have had a recent transient ischemic attack (TIA), a stroke without lasting arm weakness, or atrial fibrillation (a type of irregular heartbeat). If you are 50 years or older, have certain health conditions, and use a smartphone, you may be eligible to join the study.

If you participate, you will receive a Stroke Alarm bracelet to wear for three months. The researchers will gather information about your health at the start of the study, after three months, and by using national health records. The goal is to determine how effectively the Stroke Alarm can identify strokes in their early stages. This study is currently recruiting participants, so if you think you might qualify, consider discussing it with your doctor for more details.

Gender

ALL

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.