Multicentre, national, investigator-initiated, randomised, parallel-group, register-based superiority trial to compare extended ECG monitoring versus standard ECG monitoring in elderly patients with ischaemic stroke or transient ischaemic attack and the effect on stroke, death and intracerebral bleeding: the AF SPICE protocol
Introduction Atrial fibrillation (AF) is a major risk factor for ischaemic stroke and transient ischaemic attack (TIA), and AF detection can be challenged by asymptomatic and paroxysmal presentation. Long-term ECG monitoring after ischaemic stroke or TIA is recommended by all major societies in card...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2023-11-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/11/e073470.full |
| _version_ | 1797431034379239424 |
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| author | Emma Svennberg Johan Engdahl Bo Norrving Mia von Euler Marie Eriksson Per Wester Sara Själander Kajsa Straat Eva Isaksson Elisabeth Rooth Kjersti Hellqvist Weigang Gu Jakob O Ström Signild Åsberg |
| author_facet | Emma Svennberg Johan Engdahl Bo Norrving Mia von Euler Marie Eriksson Per Wester Sara Själander Kajsa Straat Eva Isaksson Elisabeth Rooth Kjersti Hellqvist Weigang Gu Jakob O Ström Signild Åsberg |
| author_sort | Emma Svennberg |
| collection | DOAJ |
| description | Introduction Atrial fibrillation (AF) is a major risk factor for ischaemic stroke and transient ischaemic attack (TIA), and AF detection can be challenged by asymptomatic and paroxysmal presentation. Long-term ECG monitoring after ischaemic stroke or TIA is recommended by all major societies in cardiology and cerebrovascular medicine as a secondary prophylactic measure. However, data on stroke reduction are lacking, and the recommendations show significant diversity.Methods and analysis AF SPICE is a multicentre, national, investigator-initiated, randomised, parallel-group, register-based trial comparing extended ECG monitoring versus standard ECG monitoring in patients admitted with ischaemic stroke or TIA, with a composite endpoint of stroke, all-cause-mortality and intracerebral bleeding. Patients aged ≥70 years without previous AF will be randomised 1:1 to control (standard ECG monitoring) or intervention (extended ECG monitoring). In the control arm, patients will undergo 48±24 hours (ie, a range of 24–72 hours) of continuous ECG monitoring according to national recommendations. In the intervention arm, patients will undergo 14+14 days of continuous ECG monitoring 3 months apart using an ECG patch device, which will provide an easy-accessed, well-tolerated 14-day continuous ECG recording. All ECG patch recordings will be read in a core facility. In cases of AF detection, oral anticoagulation will be recommended if not contraindicated. A pilot phase has been concluded in 2022, which will transcend into the main trial during 2023–2026, including approximately 30 stroke units. The sample size was calculated to be 3262 patients. The primary outcome will be collected from register data during a 36-month follow-up.Ethics and dissemination Ethical approval has been provided by the Swedish Ethical Review Authority, reference 2021–02770. The trial will be conducted according to the ethical principles of the Declaration of Helsinki and national regulatory standards. Positive results from the study have the potential for rapid dissemination in clinical practice.Trial registration number NCT05134454. |
| first_indexed | 2024-03-09T09:37:06Z |
| format | Article |
| id | doaj.art-b4c0409bab2e4b2a9a0775b5336eea6b |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-09T09:37:06Z |
| publishDate | 2023-11-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-b4c0409bab2e4b2a9a0775b5336eea6b2023-12-02T01:35:08ZengBMJ Publishing GroupBMJ Open2044-60552023-11-01131110.1136/bmjopen-2023-073470Multicentre, national, investigator-initiated, randomised, parallel-group, register-based superiority trial to compare extended ECG monitoring versus standard ECG monitoring in elderly patients with ischaemic stroke or transient ischaemic attack and the effect on stroke, death and intracerebral bleeding: the AF SPICE protocolEmma Svennberg0Johan Engdahl1Bo Norrving2Mia von Euler3Marie Eriksson4Per Wester5Sara Själander6Kajsa Straat7Eva Isaksson8Elisabeth Rooth9Kjersti Hellqvist10Weigang Gu11Jakob O Ström12Signild Åsberg13Department of Medicine, Huddinge, Karolinska University Hospital, Karolinska Institutet, Stockholm, Stockholm, SwedenDepartment of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Stockholm, SwedenSection of Neurology, Department of Clinical Sciences, Lund University, Lund, SwedenSchool of Medicine, Department of Neurology, Orebro universitet, Orebro, Örebro, SwedenDepartment of Statistics, USBE, Umeå University, Umea, SwedenDepartment of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Stockholm, SwedenDepartment of Public Health and Clinical Medicine, Umeå University, Umea, SwedenDepartment of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Stockholm, SwedenDepartment of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Stockholm, SwedenDepartment of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Stockholm, SwedenDepartment of Medicine, Alingsas lasarett, Alingsas, SwedenDepartment of Clinical Sciences, South Hospital, Karolinska Institutet, Stockholm, Stockholm, SwedenSchool of Medicine, Department of Neurology, Orebro universitet, Orebro, Örebro, SwedenDepartment of Medical Sciences, Uppsala University, Uppsala, SwedenIntroduction Atrial fibrillation (AF) is a major risk factor for ischaemic stroke and transient ischaemic attack (TIA), and AF detection can be challenged by asymptomatic and paroxysmal presentation. Long-term ECG monitoring after ischaemic stroke or TIA is recommended by all major societies in cardiology and cerebrovascular medicine as a secondary prophylactic measure. However, data on stroke reduction are lacking, and the recommendations show significant diversity.Methods and analysis AF SPICE is a multicentre, national, investigator-initiated, randomised, parallel-group, register-based trial comparing extended ECG monitoring versus standard ECG monitoring in patients admitted with ischaemic stroke or TIA, with a composite endpoint of stroke, all-cause-mortality and intracerebral bleeding. Patients aged ≥70 years without previous AF will be randomised 1:1 to control (standard ECG monitoring) or intervention (extended ECG monitoring). In the control arm, patients will undergo 48±24 hours (ie, a range of 24–72 hours) of continuous ECG monitoring according to national recommendations. In the intervention arm, patients will undergo 14+14 days of continuous ECG monitoring 3 months apart using an ECG patch device, which will provide an easy-accessed, well-tolerated 14-day continuous ECG recording. All ECG patch recordings will be read in a core facility. In cases of AF detection, oral anticoagulation will be recommended if not contraindicated. A pilot phase has been concluded in 2022, which will transcend into the main trial during 2023–2026, including approximately 30 stroke units. The sample size was calculated to be 3262 patients. The primary outcome will be collected from register data during a 36-month follow-up.Ethics and dissemination Ethical approval has been provided by the Swedish Ethical Review Authority, reference 2021–02770. The trial will be conducted according to the ethical principles of the Declaration of Helsinki and national regulatory standards. Positive results from the study have the potential for rapid dissemination in clinical practice.Trial registration number NCT05134454.https://bmjopen.bmj.com/content/13/11/e073470.full |
| spellingShingle | Emma Svennberg Johan Engdahl Bo Norrving Mia von Euler Marie Eriksson Per Wester Sara Själander Kajsa Straat Eva Isaksson Elisabeth Rooth Kjersti Hellqvist Weigang Gu Jakob O Ström Signild Åsberg Multicentre, national, investigator-initiated, randomised, parallel-group, register-based superiority trial to compare extended ECG monitoring versus standard ECG monitoring in elderly patients with ischaemic stroke or transient ischaemic attack and the effect on stroke, death and intracerebral bleeding: the AF SPICE protocol BMJ Open |
| title | Multicentre, national, investigator-initiated, randomised, parallel-group, register-based superiority trial to compare extended ECG monitoring versus standard ECG monitoring in elderly patients with ischaemic stroke or transient ischaemic attack and the effect on stroke, death and intracerebral bleeding: the AF SPICE protocol |
| title_full | Multicentre, national, investigator-initiated, randomised, parallel-group, register-based superiority trial to compare extended ECG monitoring versus standard ECG monitoring in elderly patients with ischaemic stroke or transient ischaemic attack and the effect on stroke, death and intracerebral bleeding: the AF SPICE protocol |
| title_fullStr | Multicentre, national, investigator-initiated, randomised, parallel-group, register-based superiority trial to compare extended ECG monitoring versus standard ECG monitoring in elderly patients with ischaemic stroke or transient ischaemic attack and the effect on stroke, death and intracerebral bleeding: the AF SPICE protocol |
| title_full_unstemmed | Multicentre, national, investigator-initiated, randomised, parallel-group, register-based superiority trial to compare extended ECG monitoring versus standard ECG monitoring in elderly patients with ischaemic stroke or transient ischaemic attack and the effect on stroke, death and intracerebral bleeding: the AF SPICE protocol |
| title_short | Multicentre, national, investigator-initiated, randomised, parallel-group, register-based superiority trial to compare extended ECG monitoring versus standard ECG monitoring in elderly patients with ischaemic stroke or transient ischaemic attack and the effect on stroke, death and intracerebral bleeding: the AF SPICE protocol |
| title_sort | multicentre national investigator initiated randomised parallel group register based superiority trial to compare extended ecg monitoring versus standard ecg monitoring in elderly patients with ischaemic stroke or transient ischaemic attack and the effect on stroke death and intracerebral bleeding the af spice protocol |
| url | https://bmjopen.bmj.com/content/13/11/e073470.full |
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