Wearable Devices for Secondary Prevention of Ischemic Stroke

Campus Bio-Medico University of Rome

Status: Unknown

Conditions: Atrial Fibrillation; Stroke, Ischemic

Treatments: Device: Wearable devices for identifying and measuring risk factors for ischemic stroke; Other: Standard of care monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT04282993

AN01

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

200 participants in 2 patient groups

Wearable Devices Monitoring

Experimental group

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.

Treatment:

Device: Wearable devices for identifying and measuring risk factors for ischemic stroke

Standard of Care Monitoring

Active Comparator group

Description:

Patients will be evaluated by periodical clinical visits.

Treatment:

Other: Standard of care monitoring