Wearable Devices for Secondary Prevention of Ischemic Stroke

NCT ID: NCT04282993

Last Updated: 2020-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-16

Study Completion Date

2022-06-30

Brief Summary

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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

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Conditions

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Stroke, Ischemic Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Wearable devices for identifying and measuring risk factors for ischemic stroke

Intervention Type DEVICE

Identifying and monitoring cerebrovascular risk factors using wearable devices

Standard of Care Monitoring

Patients will be evaluated by periodical clinical visits.

Group Type ACTIVE_COMPARATOR

Standard of care monitoring

Intervention Type OTHER

Periodical medical examinations

Interventions

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Wearable devices for identifying and measuring risk factors for ischemic stroke

Identifying and monitoring cerebrovascular risk factors using wearable devices

Intervention Type DEVICE

Standard of care monitoring

Periodical medical examinations

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Campus Bio-Medico University

OTHER

Sponsor Role lead

Responsible Party

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Di Lazzaro Vincenzo

Head of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vincenzo Di Lazzaro, MD

Role: PRINCIPAL_INVESTIGATOR

Campus Bio-Medico University

Locations

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Università Campus Bio-Medico di Roma

Roma, RM, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Vincenzo Di Lazzaro, MD

Role: CONTACT

+3906225411220

Facility Contacts

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Vincenzo Di Lazzaro

Role: primary

+3906225411220

Other Identifiers

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AN01

Identifier Type: -

Identifier Source: org_study_id

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