Wearable Devices for Secondary Prevention of Ischemic Stroke

Not Applicable

• Conditions: Atrial Fibrillation; Stroke, Ischemic
• Interventions: Other: Standard of care monitoring; Device: Wearable devices for identifying and measuring risk factors for ischemic stroke

• Registration Number: NCT04282993
• Lead Sponsor: Campus Bio-Medico University

Brief Summary

Ischemic stroke is an important cause of death and disability in Western countries. Different risk factors have been identified such as hypertension, diabetes, dyslipidemia, smoke, atrial fibrillation, obesity, and sedentary. The aim of this study is to evaluate the feasibility of an approach based on the use of wearable devices for the identification and reduction of risk factors in patients with previous history of ischemic stroke or transient ischemic attack.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-16
• Status Verified: 2020-02
• Study First Submitted: 2020-02-19
• Study First Submitted QC: 2020-02-24
• Study First Posted: 2020-02-25
• Last Update Submitted: 2020-02-25
• Last Update Posted: 2020-02-27
• Primary Completion: 2021-12-31
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Age greater than or equal 50 years
• Recent transient ischemic attack or minor stroke

Exclusion Criteria

• Patients with significant cognitive impairment
• Patients dependent in the instrumental activities of daily life
• Patients not able to respect the frequency of monitoring program
• Patients with history of atrial fibrillation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care Monitoring	Standard of care monitoring	Patients will be evaluated by periodical clinical visits.
Wearable Devices Monitoring	Wearable devices for identifying and measuring risk factors for ischemic stroke	Patients will be provided with wearable devices for at-home monitoring heart rhythm and rate, blood pressure, pulse oximetry, quality and quantity of sleep, and pace counting.

Primary Outcome Measures

Name	Time	Method
Compliance of patients to at-home follow-up by means of wearable devices	1 month	Number of measurements actually performed in comparison to number of expected measurements

Secondary Outcome Measures

Name	Time	Method
Atrial fibrillation Detection Rate	1 month	Percentage of subjects with atrial fibrillation detected within 1 month of follow-up
Prevalence of Recurrent Stroke or Transient Ischemic Attack	1 month	Prevalence of subjects with recurrent stroke or Transient Ischemic Attack within 1 month of follow-up

Trial Locations

Locations (1)

Università Campus Bio-Medico di Roma; 🇮🇹 Roma, RM, Italy