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Wearable Devices for Secondary Prevention of Ischemic Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04282993
Recruitment Status : Recruiting
First Posted : February 25, 2020
Last Update Posted : February 27, 2020
Sponsor:
Information provided by (Responsible Party):
Di Lazzaro Vincenzo, 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.

Condition or disease Intervention/treatment Phase
Stroke, Ischemic Atrial Fibrillation Device: Wearable devices for identifying and measuring risk factors for ischemic stroke Other: Standard of care monitoring Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Wearable Devices for Secondary Prevention of Ischemic Stroke
Actual Study Start Date : April 16, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Atrial fibrillation Detection Rate [ Time Frame: 1 month ]
    Percentage of subjects with atrial fibrillation detected within 1 month of follow-up

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04282993


Contacts
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Contact: Vincenzo Di Lazzaro, MD +3906225411220 v.dilazzaro@unicampus.it

Locations
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Italy
Università Campus Bio-Medico di Roma Recruiting
Roma, RM, Italy, 00128
Contact: Vincenzo Di Lazzaro    +3906225411220    v.dilazzaro@unicampus.it   
Sponsors and Collaborators
Campus Bio-Medico University
Investigators
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Principal Investigator: Vincenzo Di Lazzaro, MD Campus Bio-Medico University
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Responsible Party: Di Lazzaro Vincenzo, Head of Neurology, Campus Bio-Medico University
ClinicalTrials.gov Identifier: NCT04282993    
Other Study ID Numbers: AN01
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: February 27, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Atrial Fibrillation
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes