Wearable Devices for Secondary Prevention of Ischemic Stroke

Atrial Fibrillation Clinical Trial

Official title:

Wearable Devices for Secondary Prevention of Ischemic Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04282993
• Other study ID #: AN01
• Status: Recruiting
• Phase: N/A
• Start date: April 16, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: February 2020
• Source: Campus Bio-Medico University
• Contact: Vincenzo Di Lazzaro, MD
• Phone: +3906225411220
• Email: v.dilazzaro[@]unicampus.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Ischemia
• Stroke
• Stroke, Ischemic

Intervention

Device:
• Wearable devices for identifying and measuring risk factors for ischemic stroke
Identifying and monitoring cerebrovascular risk factors using wearable devices

Other:
• Standard of care monitoring
Periodical medical examinations

Locations

Country	Name	City	State
Italy	Università Campus Bio-Medico di Roma	Roma	RM

Sponsors (1)

Lead Sponsor	Collaborator
Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Atrial fibrillation Detection Rate	Percentage of subjects with atrial fibrillation detected within 1 month of follow-up	1 month
Secondary	Prevalence of Recurrent Stroke or Transient Ischemic Attack	Prevalence of subjects with recurrent stroke or Transient Ischemic Attack within 1 month of follow-up	1 month