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Wearable Devices for Secondary Prevention of Ischemic Stroke

Primary Purpose

Stroke, Ischemic, Atrial Fibrillation

Status

Unknown status

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Wearable devices for identifying and measuring risk factors for ischemic stroke

Standard of care monitoring

About this trial

This is an interventional prevention trial for Stroke, Ischemic

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Università Campus Bio-Medico di RomaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Wearable Devices Monitoring

Standard of Care Monitoring

Arm Description

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.

Patients will be evaluated by periodical clinical visits.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Atrial fibrillation Detection Rate

Percentage of subjects with atrial fibrillation detected within 1 month of follow-up

Prevalence of Recurrent Stroke or Transient Ischemic Attack

Prevalence of subjects with recurrent stroke or Transient Ischemic Attack within 1 month of follow-up

Full Information

NCT ID

NCT04282993

First Posted

February 19, 2020

Last Updated

February 25, 2020

Sponsor

Campus Bio-Medico University

1. Study Identification

Unique Protocol Identification Number

NCT04282993

Brief Title

Wearable Devices for Secondary Prevention of Ischemic Stroke

Official Title

Wearable Devices for Secondary Prevention of Ischemic Stroke

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Unknown status

Study Start Date

April 16, 2019 (Actual)

Primary Completion Date

December 31, 2021 (Anticipated)

Study Completion Date

June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Campus Bio-Medico University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Ischemic, Atrial Fibrillation

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Wearable Devices Monitoring

Arm Type

Experimental

Arm Description

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.

Arm Title

Standard of Care Monitoring

Arm Type

Active Comparator

Arm Description

Patients will be evaluated by periodical clinical visits.

Intervention Type

Device

Intervention Name(s)

Wearable devices for identifying and measuring risk factors for ischemic stroke

Intervention Description

Identifying and monitoring cerebrovascular risk factors using wearable devices

Intervention Type

Other

Intervention Name(s)

Standard of care monitoring

Intervention Description

Periodical medical examinations

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Atrial fibrillation Detection Rate

Description

Percentage of subjects with atrial fibrillation detected within 1 month of follow-up

Time Frame

1 month

Title

Prevalence of Recurrent Stroke or Transient Ischemic Attack

Description

Prevalence of subjects with recurrent stroke or Transient Ischemic Attack within 1 month of follow-up

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Vincenzo Di Lazzaro, MD

Phone

+3906225411220

v.dilazzaro@unicampus.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vincenzo Di Lazzaro, MD

Organizational Affiliation

Campus Bio-Medico University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Università Campus Bio-Medico di Roma

City

Roma

State/Province

ZIP/Postal Code

00128

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Vincenzo Di Lazzaro

Phone

+3906225411220

v.dilazzaro@unicampus.it

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Wearable Devices for Secondary Prevention of Ischemic Stroke

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