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

September 14, 2022 updated by: David Verhaert, MD, Ziekenhuis Oost-Limburg

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
225

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
AF detection with mHealth versus ILR - Percentage
Time Frame: After 6 months of having an ILR inserted and using mHealth.
Percentage of patients with AF detected
After 6 months of having an ILR inserted and using mHealth.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
AF detection with ILR - Percentage
Time Frame: After 12 months of having an ILR inserted.
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 Frame: Baseline until end of study (after 12 months of having an ILR inserted).
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
Time Frame: Baseline until end of study (after 12 months of having an ILR inserted).
Frequency of AF episodes
Baseline until end of study (after 12 months of having an ILR inserted).
AF detection with mHealth versus ILR - Duration
Time Frame: Baseline until end of study (after 12 months of having an ILR inserted).
Duration of AF episodes
Baseline until end of study (after 12 months of having an ILR inserted).
User experience and feeling of safety questionnaire
Time Frame: After 6 months of having an ILR inserted and using mHealth.
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
Time Frame: Baseline until end of study (after 12 months of having an ILR inserted).
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
Time Frame: Baseline until end of study (after 12 months of having an ILR inserted).
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ziekenhuis Oost-Limburg

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hasselt University
Jessa Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 12, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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