Mobile phones in cryptogenic strOke patients Bringing sIngle Lead ECGs for Atrial Fibrillation detection (MOBILE-AF): study protocol for a randomised controlled trial
Abstract Background Recently published randomised clinical trials indicate that prolonged electrocardiom (ECG) monitoring might enhance the detection of paroxysmal atrial fibrillation (AF) in cryptogenic stroke or transient ischaemic attack (TIA) patients. A device that might be suitable for prolong...
| Main Authors: | , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2017-08-01
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| Series: | Trials |
| Online Access: | http://link.springer.com/article/10.1186/s13063-017-2131-0 |
| _version_ | 1818331576422891520 |
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| author | Roderick W. Treskes Willem Gielen Marieke J. Wermer Robert W. Grauss Anouk P. van Alem Reza Alizadeh Dehnavi Charles J. Kirchhof Enno T. van der Velde Arie C. Maan Ron Wolterbeek Onno M. Overbeek Martin J. Schalij Serge A. Trines |
| author_facet | Roderick W. Treskes Willem Gielen Marieke J. Wermer Robert W. Grauss Anouk P. van Alem Reza Alizadeh Dehnavi Charles J. Kirchhof Enno T. van der Velde Arie C. Maan Ron Wolterbeek Onno M. Overbeek Martin J. Schalij Serge A. Trines |
| author_sort | Roderick W. Treskes |
| collection | DOAJ |
| description | Abstract Background Recently published randomised clinical trials indicate that prolonged electrocardiom (ECG) monitoring might enhance the detection of paroxysmal atrial fibrillation (AF) in cryptogenic stroke or transient ischaemic attack (TIA) patients. A device that might be suitable for prolonged ECG monitoring is a smartphone-compatible ECG device (Kardia Mobile, Alivecor, San Francisco, CA, USA) that allows the patient to record a single-lead ECG without the presence of trained health care staff. The MOBILE-AF trial will investigate the effectiveness of the ECG device for AF detection in patients with cryptogenic stroke or TIA. In this paper, the rationale and design of the MOBILE-AF trial is presented. Methods For this international, multicentre trial, 200 patients with cryptogenic stroke or TIA will be randomised. One hundred patients will receive the ECG device and will be asked to record their ECG twice daily during a period of 1 year. One hundred patients will receive a 7-day Holter monitor. Discussion The primary outcome of this study is the percentage of patients in which AF is detected in the first year after the index ischaemic stroke or TIA. Secondary outcomes include markers for AF prediction, orally administered anticoagulation therapy changes, as well as the incidence of recurrent stroke and major bleeds. First results can be expected in mid-2019. Trial registration ClinicalTrials.gov, ID: NCT02507986 . Registered on 15 July 2015. |
| first_indexed | 2024-12-13T13:22:03Z |
| format | Article |
| id | doaj.art-afcc134eec274f0c8a69be240b95ecd4 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-13T13:22:03Z |
| publishDate | 2017-08-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-afcc134eec274f0c8a69be240b95ecd42022-12-21T23:44:23ZengBMCTrials1745-62152017-08-011811910.1186/s13063-017-2131-0Mobile phones in cryptogenic strOke patients Bringing sIngle Lead ECGs for Atrial Fibrillation detection (MOBILE-AF): study protocol for a randomised controlled trialRoderick W. Treskes0Willem Gielen1Marieke J. Wermer2Robert W. Grauss3Anouk P. van Alem4Reza Alizadeh Dehnavi5Charles J. Kirchhof6Enno T. van der Velde7Arie C. Maan8Ron Wolterbeek9Onno M. Overbeek10Martin J. Schalij11Serge A. Trines12Department of Cardiology, Leiden University Medical CenterDepartment of Cardiology, Regionshospitalet HerningDepartment of Neurology, Leiden University Medical CenterDepartment of Cardiology, Haaglanden Medical CenterDepartment of Cardiology, Haaglanden Medical CenterDeparment of Cardiology, Groene Hart HospitalDepartment of Cardiology, Alrijne HospitalDepartment of Cardiology, Leiden University Medical CenterDepartment of Cardiology, Leiden University Medical CenterDepartment of Medical Statistics, Leiden University Medical CenterDepartment of Neurology, Leiden University Medical CenterDepartment of Cardiology, Leiden University Medical CenterDepartment of Cardiology, Leiden University Medical CenterAbstract Background Recently published randomised clinical trials indicate that prolonged electrocardiom (ECG) monitoring might enhance the detection of paroxysmal atrial fibrillation (AF) in cryptogenic stroke or transient ischaemic attack (TIA) patients. A device that might be suitable for prolonged ECG monitoring is a smartphone-compatible ECG device (Kardia Mobile, Alivecor, San Francisco, CA, USA) that allows the patient to record a single-lead ECG without the presence of trained health care staff. The MOBILE-AF trial will investigate the effectiveness of the ECG device for AF detection in patients with cryptogenic stroke or TIA. In this paper, the rationale and design of the MOBILE-AF trial is presented. Methods For this international, multicentre trial, 200 patients with cryptogenic stroke or TIA will be randomised. One hundred patients will receive the ECG device and will be asked to record their ECG twice daily during a period of 1 year. One hundred patients will receive a 7-day Holter monitor. Discussion The primary outcome of this study is the percentage of patients in which AF is detected in the first year after the index ischaemic stroke or TIA. Secondary outcomes include markers for AF prediction, orally administered anticoagulation therapy changes, as well as the incidence of recurrent stroke and major bleeds. First results can be expected in mid-2019. Trial registration ClinicalTrials.gov, ID: NCT02507986 . Registered on 15 July 2015.http://link.springer.com/article/10.1186/s13063-017-2131-0 |
| spellingShingle | Roderick W. Treskes Willem Gielen Marieke J. Wermer Robert W. Grauss Anouk P. van Alem Reza Alizadeh Dehnavi Charles J. Kirchhof Enno T. van der Velde Arie C. Maan Ron Wolterbeek Onno M. Overbeek Martin J. Schalij Serge A. Trines Mobile phones in cryptogenic strOke patients Bringing sIngle Lead ECGs for Atrial Fibrillation detection (MOBILE-AF): study protocol for a randomised controlled trial Trials |
| title | Mobile phones in cryptogenic strOke patients Bringing sIngle Lead ECGs for Atrial Fibrillation detection (MOBILE-AF): study protocol for a randomised controlled trial |
| title_full | Mobile phones in cryptogenic strOke patients Bringing sIngle Lead ECGs for Atrial Fibrillation detection (MOBILE-AF): study protocol for a randomised controlled trial |
| title_fullStr | Mobile phones in cryptogenic strOke patients Bringing sIngle Lead ECGs for Atrial Fibrillation detection (MOBILE-AF): study protocol for a randomised controlled trial |
| title_full_unstemmed | Mobile phones in cryptogenic strOke patients Bringing sIngle Lead ECGs for Atrial Fibrillation detection (MOBILE-AF): study protocol for a randomised controlled trial |
| title_short | Mobile phones in cryptogenic strOke patients Bringing sIngle Lead ECGs for Atrial Fibrillation detection (MOBILE-AF): study protocol for a randomised controlled trial |
| title_sort | mobile phones in cryptogenic stroke patients bringing single lead ecgs for atrial fibrillation detection mobile af study protocol for a randomised controlled trial |
| url | http://link.springer.com/article/10.1186/s13063-017-2131-0 |
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