Wearable Devices for Secondary Prevention of Ischemic Stroke

NCT04282993 | Unknown

• 1 other identifier: AN01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Ischemic; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Compliance of patients to at-home follow-up by means of wearable devices

  Number of measurements actually performed in comparison to number of expected measurements

  1 month

Secondary Outcomes (2)

• Atrial fibrillation Detection Rate

  1 month

• Prevalence of Recurrent Stroke or Transient Ischemic Attack

  1 month

Study Arms (2)

Wearable Devices Monitoring

EXPERIMENTAL

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

Standard of Care Monitoring

ACTIVE COMPARATOR

Patients will be evaluated by periodical clinical visits.

Other: Standard of care monitoring

Interventions

Wearable devices for identifying and measuring risk factors for ischemic stroke DEVICE

Identifying and monitoring cerebrovascular risk factors using wearable devices

Wearable Devices Monitoring

Standard of care monitoring OTHER

Periodical medical examinations

Standard of Care Monitoring

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Campus Bio-Medico University: lead

Study Sites (1)

Università Campus Bio-Medico di Roma

Roma, RM, 00128, Italy

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Atrial Fibrillation

Interventions

Wearable Electronic Devices

Condition Hierarchy (Ancestors)

Stroke; 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

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• Vincenzo Di Lazzaro, MD

  Campus Bio-Medico University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincenzo Di Lazzaro, MD

CONTACT

+3906225411220; v.dilazzaro@unicampus.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Neurology

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 25, 2020
• Study Start: April 16, 2019
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2022
• Last Updated: February 27, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)