Stroke Alarm Efficacy Trial

NCT06315192 | Recruiting

• 1 other identifier: CIV-22-10-041006
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 10

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. 1.recent TIA with an ABCD2 score of ≥6, large artery atherosclerosis or atrial fibrillation, OR
2. 2.recent ischemic stroke with large artery atherosclerosis or atrial fibrillation, without persisting arm motor deficit, OR
3. 3.atrial fibrillation with an CHA2DS2-Vasc score ≥ 4 without adequate anticoagulation OR
4. 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.

Conditions

Stroke Acute; Atrial Fibrillation; TIA

Keywords

Stroke; wearable; indication; sensor

Outcome Measures

Primary Outcomes (1)

• Alarm from device within 3 hours of onset of stroke with unilateral arm motor deficit.

  The alarm is recorded systematically from the device backend. The ground truth is gathered based on the medical records for stroke events during the study period.

  From enrollment to the end of treatment at 3 months

Secondary Outcomes (6)

• Time from onset of stroke with unilateral arm motor deficit until alarm by device.

  From enrollment to the end of treatment at 3 months

• Time from onset of stroke with unilateral arm motor deficit until arrival to first hospital.

  From enrollment to the end of treatment at 3 months.

• Number of alarms indicated by the device within 3 hours of onset, in patients with a subsequent clinical diagnosis of stroke.

  From enrollment to the end of treatment at 3 months.

• Number of alarms indicated by the device within 3 hours of onset, in patients with a subsequent clinical diagnosis of a stroke mimic.

  From enrollment to the end of treatment at 3 months.

• Number of IVT and/or EVT treatments.

  From enrollment to the end of treatment at 3 months

Other Outcomes (4)

• Number of false alarms

  From enrollment to the end of treatment at 3 months

• Number of patients with missed strokes

  From enrollment to the end of treatment at 3 months

• Number of patients dying during the study period.

  From enrollment to the end of treatment at 3 months

Study Arms (1)

Stroke Alarm use

EXPERIMENTAL

The patients are provided with Stroke Alarm and instructed to use it in accordance with the IFU for a 3 months period.

Device: Stroke Alarm

Interventions

Stroke Alarm DEVICE

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.

Stroke Alarm use

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Region Skane: lead
• Karolinska University Hospital: collaborator
• Stockholm South General Hospital: collaborator
• Sahlgrenska University Hospital: collaborator
• Skane University Hospital: collaborator
• Hässleholm Hospital: collaborator
• Uppsala University Hospital: collaborator
• Helsingborgs Hospital: collaborator
• University Hospital, Linkoeping: collaborator

Study Sites (10)

Sahlgrenska University Hospital

Gothenburg, Sweden

RECRUITING

Hässleholms sjukhus

Hässleholm, 28138, Sweden

RECRUITING

Helsingborg lasarett

Helsingborg, Sweden

RECRUITING

Karolinska University Hospital Huddinge

Huddinge, 14186, Sweden

RECRUITING

Linköping university hospital

Linköping, Sweden

RECRUITING

Skane University hospital

Lund, 22185, Sweden

RECRUITING

Skåne University Hospital Malmö

Malmö, 20502, Sweden

RECRUITING

Karolinska Sjukhuset

Stockholm, Sweden

RECRUITING

Södersjukhuset

Stockholm, Sweden

RECRUITING

Uppsala University hospital

Uppsala, Sweden

RECRUITING

MeSH Terms

Conditions

Stroke; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ulrika Anderson, Ms.

  Lund University

  STUDY DIRECTOR

Central Study Contacts

Magnus Esbjörnsson, MD

CONTACT

800-555-5555; magnus.esbjornsson@skane.se

Johan Wasselius, MD, PhD

CONTACT

800-555-5555; johan.wasselius@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a multicenter, prospective observational single-arm trial with a registry-based propensity matched control population.

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 18, 2024
• Study Start: September 5, 2024
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 30, 2026

Record last verified: 2026-03

Locations

SE (10)