Atrial FibrillationMOBILE-AFNCT02507986
Mobile Phones in Cryptogenic Stroke Patients Bringing Single Lead ECGs to Detect Atrial Fibrillation
A study testing Single lead ECG device and 7-Day Holter monitor. in people with Atrial Fibrillation and Ischemic Stroke, run by Leiden University at 7 sites in 2 countries.
Trial summary
The main objective of this study is to compare the incidence of detected atrial fibrillation (AF) in cryptogenic stroke patients by a single lead ECG device with the incidence of detected AF by a 7-Day Holter ECG. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Ischemic Stroke, Transient Ischemic Attack
- What is being tested?
- Single lead ECG device and 7-Day Holter monitor.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 29 Jul 2016to 4 Jan 2022
- 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
- Patients must have had an episode of symptomatic Transient ischemic attack (TIA) or episode of ischemic stroke.
- Ischemic stroke is defined as an episode of transient or neurological dysfunction caused by focal brain or retinal ischemia with recent infarction on imaging
- A TIA is defined as transient episode of neurologic dysfunction typically lasting less than one hour caused by focal brain or retinal ischemia without recent infarction on imaging.
Who cannot join
- Known etiology of TIA or ischemic stroke
- TIA or stroke caused by spinal ischemia
- TIA only presenting with non-localising symptoms
- Uncertainty about the diagnosis of TIA because of unclear clinical symptoms
- Myocardial infarction <6 months before stroke
- Coronary Artery Bypass Grafting <6 months before stroke
Show all 18Show fewer
- Severe valvular heart disease
- Documented history of atrial fibrillation or atrial flutter
- Permanent indication for oral anticoagulation at enrolment
- Patient has permanent OAC contraindication
- Patient is included in another randomized trial
- Left ventricular aneurysm on echocardiography
- Thrombus on echocardiographyRenal dysfunction (creatinine clearance <30 mL/min/1.73m2)
- Patient has life expectancy of <1 year
- Patient is not willing to sign the informed consent form
- Patient is <18 years of age
- Patient is considered an incapacitated adult
- Patient is not in possession of a smartphone with Android Operating System (OS) or iOS.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Netherlands6 sites
Reinier de Graaf Hospital
Delft, South Holland
Groene Hart Ziekenhuis
Gouda, South Holland, 2803 HH
Leiden University Medical Center
Leiden, South Holland, 2333 ZA
Alrijne Hospital
Leiderdorp, South Holland, 2353 GA
Medisch Centrum Haaglanden
The Hague, South Holland, 2512 VA
Bronovo ziekenhuis
The Hague, South Holland, 2597 AX
About this study
The main objective of this study is to compare the incidence of detected atrial fibrillation (AF) in cryptogenic stroke patients by a single lead ECG device with the incidence of detected AF by a 7-Day Holter ECG.
Read the detailed description
Rationale: A standard work-up of stroke patients to identify a cause of stroke consists of Computed Tomography (CT), CT angiography of head and neck arteries, transthoracic echocardiography, 12-lead 10-seconds electrocardiogram (ECG), blood tests and 24-hour ECG monitoring. A stroke is called "cryptogenic" if no cause can be determined after standard work-up. Current detection of atrial fibrillation (AF) after stroke is 2.0%. Recent studies revealed that prolonged monitoring yields higher percentages of detected AF (12.0%). Devices used in these trials suffer from drawbacks. The investigators' hypothesis is that a new, smartphone compatible device, producing a single lead ECG (single lead ECG device), can be used for prolonged ECG monitoring in cryptogenic stroke patients.
Objective: The main objective of this study is to compare the incidence of detected AF in cryptogenic stroke patients by a single lead ECG device with the incidence of detected AF by a 7-Day Holter ECG.
Study design: A multicenter randomized trial. Study population: Cryptogenic stroke patients admitted to a hospital participating in the study. The calculated sample size is 200 (100 per arm).
Intervention: After inclusion, patients will be randomized to either a single lead ECG device or a 7-Day Holter Monitor.
Main study parameters/endpoints: The main endpoint will be the percentage of detected atrial fibrillation in both the single lead ECG device group and the 7-Day Holter group after one year.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Both devices are battery powered and electrically safe. Patients face a 2-3% risk that AF is detected false-positively; this might lead to incorrect oral anticoagulation (OAC) prescription. However, a potential benefit of the investigators' study is that if AF is detected and treated with OAC, this significantly reduces the chance of recurrent stroke.
- Being tested
- Single lead ECG device, 7-Day Holter monitor.
- Medical subject headings
- Atrial Fibrillation, Ischemic Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single lead ECG deviceDevice
The single lead ECG device is a smartphone compatible handheld device that produces a single lead ECG after 30 seconds of measurement. It is non-invasive, electrically safe and easy to use.
7-Day Holter monitor.Device
The Holter is a conventional 7-Day Holter monitor.
| Study group | Role | What they receive |
|---|---|---|
| 7-Day Holter monitor | Active comparator | This arm will receive a 7-Day Holter monitor directly after randomization. Receives: Device: 7-Day Holter monitor. |
| Single lead ECG device | Experimental | This arm will be asked to take a single lead ECG two times per day and in case of complaints with a single lead ECG device. Receives: Device: Single lead ECG device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of detected atrial fibrillation
Measured: 1 year of follow-up
Secondary outcomes (6)
Pro-Brain Natriuretic Peptide (Pro-BNP) levels in pg/mL
Measured: 24 hours after cryptogenic stroke
Percentages of atrial ectopy detected on 7-Day Holter monitor
Measured: 7 days after cryptogenic stroke
Left atrial diameter in cm/m2
Measured: 24 hours after cryptogenic stroke
Number of participants with a recurrent stroke or TIA as defined in the trial
Measured: Within one year after cryptogenic stroke
Number of participants with a major bleeding
Measured: Within one year after cryptogenic stroke
Left atrial volume in mL/m2
Measured: 24 hours after cryptogenic stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2015 (estimated)
- Study start29 Jul 2016
- Primary completion4 Jan 2022
- Study completion4 Jan 2022
Why it stopped: no personnel for recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies 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
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Center Haaglanden, Groene Hart Ziekenhuis, Herning Hospital, Alrijne Hospital, Reinier de Graaf Groep
- Responsible party
- Principal investigator, Serge A. Trines, Leiden University Medical Center
- Investigators
- Serge Trines, MD, PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02507986
- Sponsor's protocol ID
- MOBILE-AF
- Acronym
- MOBILE-AF
- Status last verified
- Aug 2022
- First submitted
- 15 Jul 2015
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Treskes RW, Gielen W, Wermer MJ, Grauss RW, van Alem AP, Dehnavi RA, Kirchhof CJ, van der Velde ET, Maan AC, Wolterbeek R, Overbeek OM, Schalij MJ, Trines SA. Mobile phones in cryptogenic strOke patients Bringing sIngle Lead ECGs for Atrial Fibrillation detection (MOBILE-AF): study protocol for a randomised controlled trial. Trials. 2017 Aug 29;18(1):402. doi: 10.1186/s13063-017-2131-0.
PubMed 28851409
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Phones in Cryptogenic Stroke Patients Bringing Single Lead ECGs to Detect Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02507986
- Acronym / sponsor ID
- MOBILE-AF / MOBILE-AF
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no personnel for recruitment
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Leiden UniversityUniversity, hospital or other
- Collaborators
- Medical Center Haaglanden, Groene Hart Ziekenhuis, Herning Hospital, Alrijne Hospital, Reinier de Graaf Groep
- Study start
- 29 Jul 2016 (actual)
- Primary completion
- 4 Jan 2022 (actual)
- Study completion
- 4 Jan 2022 (actual)
- First posted
- 24 Jul 2015 (estimated)
- 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 main objective of this study is to compare the incidence of detected atrial fibrillation (AF) in cryptogenic stroke patients by a single lead ECG device with the incidence of detected AF by a 7-Day Holter ECG.
Detailed description
Rationale: A standard work-up of stroke patients to identify a cause of stroke consists of Computed Tomography (CT), CT angiography of head and neck arteries, transthoracic echocardiography, 12-lead 10-seconds electrocardiogram (ECG), blood tests and 24-hour ECG monitoring. A stroke is called "cryptogenic" if no cause can be determined after standard work-up. Current detection of atrial fibrillation (AF) after stroke is 2.0%. Recent studies revealed that prolonged monitoring yields higher percentages of detected AF (12.0%). Devices used in these trials suffer from drawbacks. The investigators' hypothesis is that a new, smartphone compatible device, producing a single lead ECG (single lead ECG device), can be used for prolonged ECG monitoring in cryptogenic stroke patients.
Objective: The main objective of this study is to compare the incidence of detected AF in cryptogenic stroke patients by a single lead ECG device with the incidence of detected AF by a 7-Day Holter ECG.
Study design: A multicenter randomized trial. Study population: Cryptogenic stroke patients admitted to a hospital participating in the study. The calculated sample size is 200 (100 per arm).
Intervention: After inclusion, patients will be randomized to either a single lead ECG device or a 7-Day Holter Monitor.
Main study parameters/endpoints: The main endpoint will be the percentage of detected atrial fibrillation in both the single lead ECG device group and the 7-Day Holter group after one year.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Both devices are battery powered and electrically safe. Patients face a 2-3% risk that AF is detected false-positively; this might lead to incorrect oral anticoagulation (OAC) prescription. However, a potential benefit of the investigators' study is that if AF is detected and treated with OAC, this significantly reduces the chance of recurrent stroke.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 7-Day Holter monitor | Active comparator | Device: 7-Day Holter monitor.This arm will receive a 7-Day Holter monitor directly after randomization. |
| Single lead ECG device | Experimental | Device: Single lead ECG deviceThis arm will be asked to take a single lead ECG two times per day and in case of complaints with a single lead ECG device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must have had an episode of symptomatic Transient ischemic attack (TIA) or episode of ischemic stroke.
Key exclusion criteria (18 listed)
- Known etiology of TIA or ischemic stroke
- TIA or stroke caused by spinal ischemia
- TIA only presenting with non-localising symptoms
- Uncertainty about the diagnosis of TIA because of unclear clinical symptoms
- Myocardial infarction <6 months before stroke
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 |
|---|---|---|
| Single lead ECG deviceThe single lead ECG device is a smartphone compatible handheld device that produces a single lead ECG after 30 seconds of measurement. It is non-invasive, electrically safe and easy to use. | Device | Single lead ECG device |
| 7-Day Holter monitor.The Holter is a conventional 7-Day Holter monitor. | Device | 7-Day Holter monitor |
Primary outcome
Percentage of detected atrial fibrillation
Time frame: 1 year of follow-up
6 secondary outcomes
Pro-Brain Natriuretic Peptide (Pro-BNP) levels in pg/mL
Time frame: 24 hours after cryptogenic stroke
Percentages of atrial ectopy detected on 7-Day Holter monitor
Time frame: 7 days after cryptogenic stroke
Left atrial diameter in cm/m2
Time frame: 24 hours after cryptogenic stroke
Number of participants with a recurrent stroke or TIA as defined in the trial
Time frame: Within one year after cryptogenic stroke
Number of participants with a major bleeding
Time frame: Within one year after cryptogenic stroke
Left atrial volume in mL/m2
Time frame: 24 hours after cryptogenic stroke
Results and safety
The study was stopped early (reason given: no personnel for recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Derived from this study: PubMed 28851409Treskes RW, Gielen W, Wermer MJ, Grauss RW, van Alem AP, Dehnavi RA, Kirchhof CJ, van der Velde ET, Maan AC, Wolterbeek R, Overbeek OM, Schalij MJ, Trines SA. Mobile phones in cryptogenic strOke patients Bringing sIngle Lead ECGs for Atrial Fibrillation detection (MOBILE-AF): study protocol for a randomised controlled trial. Trials. 2017 Aug 29;18(1):402. doi: 10.1186/s13063-017-2131-0.
- Individual participant dataSharing planned: Undecided
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Atrial Fibrillation (AF)
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.
Serge Trines, MD, PhD principal investigator
Leiden University Medical Center
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single lead ECG device and 7-Day Holter monitor. in people with Atrial Fibrillation and Ischemic Stroke, run by Leiden University at 7 sites in 2 countries.
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 3 inclusion and 18 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: stopped early, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Netherlands, Denmark. 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?
The study was stopped early (reason given: no personnel for recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of detected atrial fibrillation (time frame: 1 year of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02507986, which also lists 1 linked publication.
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 18 Aug 2022.