{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T20:27:50Z","timestamp":1792787270884,"version":"4.5.0"},"reference-count":26,"publisher":"BMJ","issue":"11","license":[{"start":{"date-parts":[[2023,11,23]],"date-time":"2023-11-23T00:00:00Z","timestamp":1700697600000},"content-version":"unspecified","delay-in-days":22,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"the Swedish Heart & Lung Foundation","award":["20210229"],"award-info":[{"award-number":["20210229"]}]},{"name":"the Swedish Stroke Foundation","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]},{"DOI":"10.13039\/501100001862","name":"the Swedish Research Council","doi-asserted-by":"crossref","award":["2021-06576"],"award-info":[{"award-number":["2021-06576"]}],"id":[{"id":"10.13039\/501100001862","id-type":"DOI","asserted-by":"crossref"}]},{"name":"ALF","award":["RS2021-0855"],"award-info":[{"award-number":["RS2021-0855"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2023,11,7]]},"published-print":{"date-parts":[[2023,11]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>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 \u226570 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\u00b124 hours (ie, a range of 24\u201372\u2009hours) of continuous ECG monitoring according to national recommendations. In the intervention arm, patients will undergo 14+14 days of continuous ECG monitoring 3\u2009months 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\u20132026, 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Ethical approval has been provided by the Swedish Ethical Review Authority, reference 2021\u201302770. 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT05134454\">NCT05134454<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2023-073470","type":"journal-article","created":{"date-parts":[[2023,11,23]],"date-time":"2023-11-23T12:52:18Z","timestamp":1700743938000},"page":"e073470","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":8,"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"],"prefix":"10.1136","volume":"13","clinical-trial-number":[{"clinical-trial-number":"nct05134454","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1677-7215","authenticated-orcid":false,"given":"Johan","family":"Engdahl","sequence":"first","affiliation":[{"name":"Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kajsa","family":"Straat","sequence":"additional","affiliation":[{"name":"Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0289-8750","authenticated-orcid":false,"given":"Eva","family":"Isaksson","sequence":"additional","affiliation":[{"name":"Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisabeth","family":"Rooth","sequence":"additional","affiliation":[{"name":"Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emma","family":"Svennberg","sequence":"additional","affiliation":[{"name":"Department of Medicine, Huddinge, Karolinska University Hospital, Karolinska Institutet, Stockholm, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bo","family":"Norrving","sequence":"additional","affiliation":[{"name":"Section of Neurology, Department of Clinical Sciences, Lund University, Lund, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mia von","family":"Euler","sequence":"additional","affiliation":[{"name":"School of Medicine, Department of Neurology, Orebro universitet, Orebro, \u00d6rebro, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kjersti","family":"Hellqvist","sequence":"additional","affiliation":[{"name":"Department of Medicine, Alingsas lasarett, Alingsas, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Weigang","family":"Gu","sequence":"additional","affiliation":[{"name":"Department of Clinical Sciences, South Hospital, Karolinska Institutet, Stockholm, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jakob O","family":"Str\u00f6m","sequence":"additional","affiliation":[{"name":"School of Medicine, Department of Neurology, Orebro universitet, Orebro, \u00d6rebro, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara","family":"Sj\u00e4lander","sequence":"additional","affiliation":[{"name":"Department of Public Health and Clinical Medicine, Ume\u00e5 University, Umea, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marie","family":"Eriksson","sequence":"additional","affiliation":[{"name":"Department of Statistics, USBE, Ume\u00e5 University, Umea, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Signild","family":"\u00c5sberg","sequence":"additional","affiliation":[{"name":"Department of Medical Sciences, Uppsala University, Uppsala, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Per","family":"Wester","sequence":"additional","affiliation":[{"name":"Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Stockholm, Sweden"},{"name":"Department of Public Health and Clinical Medicine, Ume\u00e5 University, Umea, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2023,11,23]]},"reference":[{"key":"2025121220420115000_13.11.e073470.1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(21)00252-0"},{"key":"2025121220420115000_13.11.e073470.2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(16)30962-X"},{"key":"2025121220420115000_13.11.e073470.3","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(16)30506-2"},{"key":"2025121220420115000_13.11.e073470.4","doi-asserted-by":"crossref","first-page":"3233","DOI":"10.1161\/STROKEAHA.120.033893","article-title":"Sex differences in stroke care and outcome 2005-2018: observations from the Swedish stroke register","volume":"52","author":"Eriksson","year":"2021","journal-title":"Stroke"},{"key":"2025121220420115000_13.11.e073470.5","unstructured":"Riksstroke . Riksstroke english summary 2021, . 2023 Available: https:\/\/www.riksstroke.org\/annual-reports-and-graphs\/"},{"key":"2025121220420115000_13.11.e073470.6","doi-asserted-by":"publisher","DOI":"10.1161\/STROKEAHA.115.009912"},{"key":"2025121220420115000_13.11.e073470.7","doi-asserted-by":"crossref","first-page":"3","DOI":"10.1111\/ane.13168","article-title":"Recurrent ischemic stroke: incidence, predictors, and impact on mortality","volume":"141","author":"Khanevski","year":"2020","journal-title":"Acta Neurol Scand"},{"key":"2025121220420115000_13.11.e073470.8","doi-asserted-by":"crossref","first-page":"683","DOI":"10.1016\/j.nic.2018.06.009","article-title":"Economic and societal aspects of stroke management","volume":"28","author":"Mukundan","year":"2018","journal-title":"Neuroimaging Clin N Am"},{"key":"2025121220420115000_13.11.e073470.9","doi-asserted-by":"publisher","DOI":"10.1161\/STROKEAHA.116.012865"},{"key":"2025121220420115000_13.11.e073470.10","doi-asserted-by":"publisher","DOI":"10.1161\/STROKEAHA.113.002329"},{"key":"2025121220420115000_13.11.e073470.11","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-146-12-200706190-00007"},{"key":"2025121220420115000_13.11.e073470.12","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1311376"},{"key":"2025121220420115000_13.11.e073470.13","doi-asserted-by":"publisher","DOI":"10.1161\/STROKEAHA.113.001884"},{"key":"2025121220420115000_13.11.e073470.14","article-title":"Cryptogenic stroke and atrial fibrillation","volume":"371","author":"Sanna","year":"2014","journal-title":"N Engl J Med"},{"key":"2025121220420115000_13.11.e073470.15","doi-asserted-by":"crossref","first-page":"282","DOI":"10.1016\/S1474-4422(17)30002-9","article-title":"Holter-electrocardiogram-monitoring in patients with acute ischaemic stroke (find-AFRANDOMISED): an open-label randomised controlled trial","volume":"16","author":"Wachter","year":"2017","journal-title":"The Lancet Neurology"},{"key":"2025121220420115000_13.11.e073470.16","doi-asserted-by":"crossref","first-page":"426","DOI":"10.1016\/S1474-4422(21)00067-3","article-title":"Systematic monitoring for detection of atrial fibrillation in patients with acute ischaemic stroke (Mondafis): a randomised, open-label, Multicentre study","volume":"20","author":"Haeusler","year":"2021","journal-title":"Lancet Neurol"},{"key":"2025121220420115000_13.11.e073470.17","unstructured":"NICE AF post stroke guidelines. 2023. Available: https:\/\/www.nice.org.uk\/guidance\/dg41\/"},{"key":"2025121220420115000_13.11.e073470.18","doi-asserted-by":"publisher","DOI":"10.1016\/j.cjca.2020.09.001"},{"key":"2025121220420115000_13.11.e073470.19","doi-asserted-by":"publisher","DOI":"10.1016\/j.hlc.2018.06.1043"},{"key":"2025121220420115000_13.11.e073470.20","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehaa612"},{"key":"2025121220420115000_13.11.e073470.21","doi-asserted-by":"publisher","DOI":"10.1161\/STR.0000000000000375"},{"key":"2025121220420115000_13.11.e073470.22","unstructured":"Physicians Rco . National guideline for stroke London 2016, Fifth edition, Available: https:\/\/www.strokeaudit.org\/Guideline\/Full-Guideline.aspx"},{"key":"2025121220420115000_13.11.e073470.23","doi-asserted-by":"crossref","DOI":"10.1177\/23969873221099478","article-title":"European stroke Organisation (ESO) guideline on screening for Subclinical atrial fibrillation after stroke or transient ischaemic attack of undetermined origin","volume":"7","author":"Rubiera","year":"2022","journal-title":"Eur Stroke J"},{"key":"2025121220420115000_13.11.e073470.24","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.119.040267"},{"key":"2025121220420115000_13.11.e073470.25","first-page":"113","article-title":"Cerebrovascular disease in the community: results of a WHO collaborative study","volume":"58","author":"Aho","year":"1980","journal-title":"Bull World Health Organ"},{"key":"2025121220420115000_13.11.e073470.26","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2013.281053"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2023-073470","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,13]],"date-time":"2025-12-13T04:42:12Z","timestamp":1765600932000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2023-073470"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,11]]},"references-count":26,"journal-issue":{"issue":"11","published-online":{"date-parts":[[2023,11,23]]},"published-print":{"date-parts":[[2023,11]]}},"alternative-id":["10.1136\/bmjopen-2023-073470"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2023-073470","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,11]]}}}