Early Detection of Atrial Fibrillation Using Mobile Technology in Cryptogenic Stroke Patients (REMOTE)

East Limburg Hospital

Status: Enrolling

Conditions: Atrial Fibrillation; Cryptogenic Stroke

Treatments: Device: seven-day ECG Holter; Device: Insertable loop recorder; Device: 24-hour blood pressure monitor; Other: Questionnaire: vision of mHealth; Other: Questionnaire: user experience & feeling of safety

Study type: Interventional

Funder types: Other

Identifiers

NCT05006105

CTU2019106

Details and patient eligibility

About

The purpose of this study is to demonstrate the added value of mobile health (mHealth) to detect atrial fibrillation (AF) early in the care path of cryptogenic stroke and transient ischemic attack (TIA) patients.

Full description

The use of photoplethysmography (PPG)-based mHealth (with smartphone and smartwatch) is compared to the guideline-recommended insertable loop recorders (ILR) in the detection of AF in cryptogenic stroke or TIA patients.

Enrollment: 225 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of cryptogenic ischemic stroke or TIA
• The patient or its legal representative is willing to sign the informed consent

Exclusion criteria

• History of AF or atrial flutter
• Life expectancy of less than one year
• Not qualified for ILR insertion
• Indication or contraindication for permanent oral anticoagulants (OAC) at enrolment
• Untreated hyperthyroidism
• Myocardial infarction or coronary bypass grafting less than one month before the stroke onset
• Presence of patent foramen ovale (PFO) and it is or was an indication to start OAC according to the European Stroke Organization guidelines
• Inclusion in another clinical trial that will affect the objectives of this study
• Not able to understand the Dutch language
• Patient or partner not in possession of a smartphone

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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225 participants in 2 patient groups

PPG-based mHealth on smartphone

Experimental group

Description:

Participants used PPG-based mHealth on a smartphone for 6 months. Participants were asked to perform two spot-check measurements and additional measurements in case of symptoms. The use of PPG-based mHealth on a smartphone was initiated on the day of insertable loop recorder insertion.

Treatment:

Device: seven-day ECG Holter

Other: Questionnaire: vision of mHealth

Device: Insertable loop recorder

Device: 24-hour blood pressure monitor

Other: Questionnaire: user experience & feeling of safety

PPG-based mHealth on smartwatch

Experimental group

Description:

Participants used PPG-based mHealth on a smartwatch for 6 months. Participants were asked to wear the smartwatch continuously (except during battery charging). The use of PPG-based mHealth on a smartwatch was initiated on the day of insertable loop recorder insertion.

Treatment:

Device: seven-day ECG Holter

Other: Questionnaire: vision of mHealth

Device: Insertable loop recorder

Device: 24-hour blood pressure monitor

Other: Questionnaire: user experience & feeling of safety