Stroke Alarm Efficacy Trial

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, OR
2. recent stroke without persisting arm motor deficit, OR
3. atrial fibrillation A control population matched for age, sex, NIHSS score and health care region will be identified in the Swedish national stroke registry, Riksstroke, and used for comparison.

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

Interventions

DEVICE

Stroke Alarm

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.

Sponsors & Collaborators

• Karolinska University Hospital

  collaborator OTHER

• Stockholm South General Hospital

  collaborator OTHER

• Sahlgrenska University Hospital

  collaborator OTHER

• Skane University Hospital

  collaborator OTHER

• Region Skane

  lead OTHER

Principal Investigators

• Ulrika Anderson, Ms. · Lund University

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-05

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• Sweden

Study Locations