Cryptogenic StrokeREMOTENCT05006105
Early Detection of Atrial Fibrillation Using Mobile Technology in Cryptogenic Stroke Patients
A study testing seven-day ECG Holter, 24-hour blood pressure monitor and Questionnaire: vision of mHealth in people with Cryptogenic Stroke and Atrial Fibrillation, run by Ziekenhuis Oost-Limburg at 2 sites in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cryptogenic Stroke, Atrial Fibrillation
- What is being tested?
- seven-day ECG Holter, 24-hour blood pressure monitor and Questionnaire: vision of mHealth
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 2 sitesBelgium
- Study dates
- 12 Oct 2020to Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of cryptogenic ischemic stroke or TIA
- The patient or its legal representative is willing to sign the informed consent
Who cannot join
- 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
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- 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 locations and contacts
2 sites in 1 country.
Femke Wouters contact
Belgium2 sites, 2 recruiting
- Recruiting
Ziekenhuist Oost-Limburg
Genk, Limburg, 3600
David Verhaert, Dr., david.verhaert@zol.be
Femke Wouters, MSc, femke.wouters@uhasselt.be
- Recruiting
Jessa Hospital
Hasselt, Limburg, 3500
Thomas Phlips, Dr., thomas.phlips@jessazh.be
Femke Wouters, MSc, femke.wouters@uhasselt.be
About this study
Official title: 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.
Read the 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.
- Conditions
- Cryptogenic Stroke, Atrial Fibrillation
- Being tested
- seven-day ECG Holter, 24-hour blood pressure monitor, Questionnaire: vision of mHealth, Questionnaire: user experience & feeling of safety, Insertable loop recorder
- Keywords
- Mobile health, Prolonged cardiac monitoring, Photoplethysmography
- Medical subject headings
- Ischemic Stroke, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
seven-day ECG HolterDevice
Participants receive a seven-day ECG Holter after hospital discharge.
24-hour blood pressure monitorDevice
Participants receive a 24-hour blood pressure monitor, approximately four weeks after hospital discharge.
Questionnaire: vision of mHealthOther
Participants receive a questionnaire concerning their vision of mHealth, approximately four weeks after hospital discharge.
Questionnaire: user experience & feeling of safetyOther
Participants receive a questionnaire concerning their user experience and feeling of safety of using mHealth, after using mHealth for six months.
Insertable loop recorderDevice
Participants receive an insertable loop recorder, approximately six weeks after hospital discharge.
| Study group | Role | What they receive |
|---|---|---|
| PPG-based mHealth on smartphone | Experimental | 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. Receives: 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 |
| PPG-based mHealth on smartwatch | Experimental | 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AF detection with mHealth versus ILR - Percentage
Percentage of patients with AF detected
Measured: After 6 months of having an ILR inserted and using mHealth.
Secondary outcomes (7)
AF detection with ILR - Percentage
Percentage of patients with AF detected
Measured: After 12 months of having an ILR inserted.
AF detection with mHealth versus ILR - Time to first AF detection
Time to first AF detection
Measured: Baseline until end of study (after 12 months of having an ILR inserted).
AF detection with mHealth versus ILR - Frequency
Frequency of AF episodes
Measured: Baseline until end of study (after 12 months of having an ILR inserted).
AF detection with mHealth versus ILR - Duration
Duration of AF episodes
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline until end of study (after 12 months of having an ILR inserted).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start12 Oct 2020
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cryptogenic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Collaborators
- Hasselt University, Jessa Hospital
- Responsible party
- Principal investigator, David Verhaert, MD, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006105
- Sponsor's protocol ID
- CTU2019106
- Acronym
- REMOTE
- Status last verified
- Sep 2022
- First submitted
- 13 Jul 2021
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Atrial Fibrillation Using Mobile Technology in Cryptogenic Stroke Patients - REMOTE Study
- ClinicalTrials.gov ID
- NCT05006105
- Acronym / sponsor ID
- REMOTE / CTU2019106
- Conditions
- Cryptogenic Stroke, Atrial Fibrillation
- Keywords
- Mobile health, Prolonged cardiac monitoring, Photoplethysmography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Collaborators
- Hasselt University, Jessa Hospital
- Study start
- 12 Oct 2020 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| PPG-based mHealth on smartphone | Experimental | 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 recorderParticipants 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. |
| PPG-based mHealth on smartwatch | Experimental | 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 recorderParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of cryptogenic ischemic stroke or TIA
- The patient or its legal representative is willing to sign the informed consent
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| seven-day ECG HolterParticipants receive a seven-day ECG Holter after hospital discharge. | Device | PPG-based mHealth on smartphone, PPG-based mHealth on smartwatch |
| 24-hour blood pressure monitorParticipants receive a 24-hour blood pressure monitor, approximately four weeks after hospital discharge. | Device | PPG-based mHealth on smartphone, PPG-based mHealth on smartwatch |
| Questionnaire: vision of mHealthParticipants receive a questionnaire concerning their vision of mHealth, approximately four weeks after hospital discharge. | Other | PPG-based mHealth on smartphone, PPG-based mHealth on smartwatch |
| Questionnaire: user experience & feeling of safetyParticipants receive a questionnaire concerning their user experience and feeling of safety of using mHealth, after using mHealth for six months. | Other | PPG-based mHealth on smartphone, PPG-based mHealth on smartwatch |
| Insertable loop recorderParticipants receive an insertable loop recorder, approximately six weeks after hospital discharge. | Device | PPG-based mHealth on smartphone, PPG-based mHealth on smartwatch |
Primary outcome
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
7 secondary outcomes
AF detection with ILR - Percentage
Time frame: 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).
AF detection with mHealth versus ILR - Frequency
Time frame: 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).
User experience and feeling of safety questionnaire
Time frame: 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).
Correlation between follow-up characteristics and AF detection
Time frame: Baseline until end of study (after 12 months of having an ILR inserted).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Femke Wouters contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing seven-day ECG Holter, 24-hour blood pressure monitor and Questionnaire: vision of mHealth in people with Cryptogenic Stroke and Atrial Fibrillation, run by Ziekenhuis Oost-Limburg at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Verhaert, Dr. (+3289 32 70 91, david.verhaert@zol.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AF detection with mHealth versus ILR - Percentage (time frame: After 6 months of having an ILR inserted and using mHealth.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2022.