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

Atrial Fibrillation Clinical Trial

— REMOTE  

Official title:

Early Detection of Atrial Fibrillation Using Mobile Technology in Cryptogenic Stroke Patients - REMOTE Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05006105
• Other study ID #: CTU2019106
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2020
• Est. completion date: February 2025

Study information

• Verified date: September 2022
• Source: Ziekenhuis Oost-Limburg
• Contact: David Verhaert, Dr.
• Phone: +3289 32 70 91
• Email: david.verhaert[@]zol.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cryptogenic Stroke
• Ischemic Stroke
• Stroke

Intervention

Device:
• seven-day ECG Holter
Participants receive a seven-day ECG Holter after hospital discharge.
• 24-hour blood pressure monitor
Participants receive a 24-hour blood pressure monitor, approximately four weeks after hospital discharge.

Other:
• Questionnaire: vision of mHealth
Participants receive a questionnaire concerning their vision of mHealth, approximately four weeks after hospital discharge.
• Questionnaire: user experience & feeling of safety
Participants receive a questionnaire concerning their user experience and feeling of safety of using mHealth, after using mHealth for six months.

Device:
• Insertable loop recorder
Participants receive an insertable loop recorder, approximately six weeks after hospital discharge.

Locations

Country	Name	City	State
Belgium	Ziekenhuist Oost-Limburg	Genk	Limburg
Belgium	Jessa Hospital	Hasselt	Limburg

Sponsors (3)

Lead Sponsor	Collaborator
Ziekenhuis Oost-Limburg	Hasselt University, Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AF detection with mHealth versus ILR - Percentage	Percentage of patients with AF detected	After 6 months of having an ILR inserted and using mHealth.
Secondary	AF detection with ILR - Percentage	Percentage of patients with AF detected	After 12 months of having an ILR inserted.
Secondary	AF detection with mHealth versus ILR - Time to first AF detection	Time to first AF detection	Baseline until end of study (after 12 months of having an ILR inserted).
Secondary	AF detection with mHealth versus ILR - Frequency	Frequency of AF episodes	Baseline until end of study (after 12 months of having an ILR inserted).
Secondary	AF detection with mHealth versus ILR - Duration	Duration of AF episodes	Baseline until end of study (after 12 months of having an ILR inserted).
Secondary	User experience and feeling of safety questionnaire	Questionnaire with a 7 point Likert scale	After 6 months of having an ILR inserted and using mHealth.
Secondary	Correlation between baseline characteristics and AF detection	Baseline characteristics include comorbidities, results of standard of care in-hospital stroke examinations and scores, relevant in-hospital therapy	Baseline until end of study (after 12 months of having an ILR inserted).
Secondary	Correlation between follow-up characteristics and AF detection	Follow-up characteristics include changes in therapy, number of relevant readmissions, mortality and healthcare-related costs	Baseline until end of study (after 12 months of having an ILR inserted).