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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation; Cryptogenic Stroke
• Intervention / Treatment: Device: seven-day ECG Holter; Device: 24-hour blood pressure monitor; Other: Questionnaire: vision of mHealth; Other: Questionnaire: user experience & feeling of safety; Device: Insertable loop recorder

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.

• Study Type: Interventional
• Enrollment (Anticipated): 225
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Verhaert, Dr.; Phone Number: +3289 32 70 91; Email: david.verhaert@zol.be
• Study Contact Backup: Name: Femke Wouters; Email: femke.wouters@zol.be

Study Locations

• Belgium
  • Limburg
    • Genk, Limburg, Belgium, 3600
      • Recruiting
      • Ziekenhuist Oost-Limburg
      • Contact: David Verhaert, Dr.; Email: david.verhaert@zol.be
      • Contact: Femke Wouters, MSc; Email: femke.wouters@uhasselt.be
      • Principal Investigator: David Verhaert, Dr.
    • Hasselt, Limburg, Belgium, 3500
      • Recruiting
      • Jessa Hospital
      • Contact: Femke Wouters, MSc; Email: femke.wouters@uhasselt.be
      • Contact: Thomas Phlips, Dr.; Email: thomas.phlips@jessazh.be
      • Principal Investigator: Thomas Phlips, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PPG-based mHealth on smartphone; 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.	Device: seven-day ECG Holter; Participants receive a seven-day ECG Holter after hospital discharge.; Device: 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.; Other: 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.
Experimental: PPG-based mHealth on smartwatch; 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.	Device: seven-day ECG Holter; Participants receive a seven-day ECG Holter after hospital discharge.; Device: 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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
AF detection with ILR - Percentage	Percentage of patients with AF detected	After 12 months of having an ILR inserted.
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).
AF detection with mHealth versus ILR - Frequency	Frequency of AF episodes	Baseline until end of study (after 12 months of having an ILR inserted).
AF detection with mHealth versus ILR - Duration	Duration of AF episodes	Baseline until end of study (after 12 months of having an ILR inserted).
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.
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).
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).

Collaborators and Investigators

• Sponsor: Ziekenhuis Oost-Limburg
• Collaborators: Hasselt University; Jessa Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2020
• Primary Completion (Anticipated): February 1, 2025
• Study Completion (Anticipated): February 1, 2025

Study Registration Dates

• First Submitted: July 13, 2021
• First Submitted That Met QC Criteria: August 6, 2021
• First Posted (Actual): August 16, 2021

Study Record Updates

• Last Update Posted (Actual): September 16, 2022
• Last Update Submitted That Met QC Criteria: September 14, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Photoplethysmography; Mobile health; Prolonged cardiac monitoring
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arrhythmias, Cardiac; Stroke; Ischemic Stroke; Atrial Fibrillation
• Other Study ID Numbers: CTU2019106

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No