Wearable Devices for Secondary Prevention of Ischemic Stroke

February 25, 2020 updated by: Di Lazzaro Vincenzo, Campus Bio-Medico University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • RM
      • Roma, RM, Italy, 00128
        • Recruiting
        • Università Campus Bio-Medico di Roma
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Wearable Devices Monitoring
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.
Device: Wearable devices for identifying and measuring risk factors for ischemic stroke
Identifying and monitoring cerebrovascular risk factors using wearable devices
Active Comparator: Standard of Care Monitoring
Patients will be evaluated by periodical clinical visits.
Other: Standard of care monitoring
Periodical medical examinations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance of patients to at-home follow-up by means of wearable devices
Time Frame: 1 month
Number of measurements actually performed in comparison to number of expected measurements
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Atrial fibrillation Detection Rate
Time Frame: 1 month
Percentage of subjects with atrial fibrillation detected within 1 month of follow-up
1 month
Prevalence of Recurrent Stroke or Transient Ischemic Attack
Time Frame: 1 month
Prevalence of subjects with recurrent stroke or Transient Ischemic Attack within 1 month of follow-up
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Campus Bio-Medico University

Investigators

  • Principal Investigator: Vincenzo Di Lazzaro, MD, Campus Bio-Medico University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2019

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

February 19, 2020

First Submitted That Met QC Criteria

February 24, 2020

First Posted (Actual)

February 25, 2020

Study Record Updates

Last Update Posted (Actual)

February 27, 2020

Last Update Submitted That Met QC Criteria

February 25, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AN01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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