Clinical trial NCT05006105: Early Detection of Atrial Fibrillation Using Mobile Technology in Cryptogenic Stroke Patients
Official title: Early Detection of Atrial Fibrillation Using Mobile Technology in Cryptogenic Stroke Patients - REMOTE Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cryptogenic Stroke
Atrial Fibrillation
Keywords: Mobile health
Prolonged cardiac monitoring
Photoplethysmography
Lead sponsor: Ziekenhuis Oost-Limburg
Sponsor class: OTHER
Collaborators: name: Hasselt University
name: Jessa Hospital
First posted: 2021-08-16
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1 uses PPG-based mHealth with a smartphone; two times a day, a spot-check measurement is taken; and in case of symptoms, additional measurements can be taken.

Group 2 uses PPG-based mHealth with a smartwatch, this results in semi-continuous measurements that are performed automatically.
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: AF detection with mHealth versus ILR - Percentage
timeFrame: After 6 months of having an ILR inserted and using mHealth.
Secondary outcomes:
measure: AF detection with ILR - Percentage
timeFrame: After 12 months of having an ILR inserted.
measure: AF detection with mHealth versus ILR - Time to first AF detection
timeFrame: Baseline until end of study (after 12 months of having an ILR inserted).
measure: AF detection with mHealth versus ILR - Frequency
timeFrame: Baseline until end of study (after 12 months of having an ILR inserted).
measure: AF detection with mHealth versus ILR - Duration
timeFrame: Baseline until end of study (after 12 months of having an ILR inserted).
measure: User experience and feeling of safety questionnaire
timeFrame: After 6 months of having an ILR inserted and using mHealth.
measure: Correlation between baseline characteristics and AF detection
timeFrame: Baseline until end of study (after 12 months of having an ILR inserted).
measure: Correlation between follow-up characteristics and AF detection
timeFrame: Baseline until end of study (after 12 months of having an ILR inserted).
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuist Oost-Limburg
state: Limburg
city: Hasselt
country: Belgium
facility: Jessa Hospital
state: Limburg
Study officials:
References: