{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,11]],"date-time":"2026-07-11T05:08:51Z","timestamp":1783746531455,"version":"3.55.0"},"reference-count":30,"publisher":"MDPI AG","issue":"10","license":[{"start":{"date-parts":[[2019,9,23]],"date-time":"2019-09-23T00:00:00Z","timestamp":1569196800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Tuscany region and Italian Ministry of Health","award":["Grant Aimed Research Call \u201cBando Ricerca Finalizzata 2013\u201d GR-2013-02355523"],"award-info":[{"award-number":["Grant Aimed Research Call \u201cBando Ricerca Finalizzata 2013\u201d GR-2013-02355523"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Medicina"],"abstract":"<jats:p>Background and Objectives: In anticoagulated atrial fibrillation (AF) patients, the validity of models recommended for the stratification of the risk ratio between benefits and hemorrhage risk is limited. Cerebral small vessel disease (SVD) represents the pathologic substrate for primary intracerebral hemorrhage and ischemic stroke. We hypothesize that biological markers\u2014both circulating and imaging-based\u2014and their possible interaction, might improve the prediction of bleeding risk in AF patients under treatment with any type of oral anticoagulant. Materials and Methods: The Strat-AF study is an observational, prospective, single-center hospital-based study enrolling patients with AF, aged 65 years or older, and with no contraindications to magnetic resonance imaging (MRI), referring to Center of Thrombosis outpatient clinic of our University Hospital for the management of oral anticoagulation therapy. Recruited patients are evaluated by means of a comprehensive protocol, with clinical, cerebral MRI, and circulating biomarkers assessment at baseline and after 18 months. The main outcome is SVD progression\u2014particularly microbleeds\u2014as a selective surrogate marker of hemorrhagic complication. Stroke occurrence (ischemic or hemorrhagic) and the progression of functional, cognitive, and motor status will be evaluated as secondary outcomes. Circulating biomarkers may further improve predictive potentials. Results: Starting from September 2017, 194 patients (mean age 78.1 \u00b1 6.7, range 65\u201397; 61% males) were enrolled. The type of AF was paroxysmal in 93 patients (48%), and persistent or permanent in the remaining patients. Concerning the type of oral anticoagulant, 57 patients (29%) were on vitamin K antagonists, and 137 (71%) were on direct oral anticoagulants. Follow-up clinical evaluation and brain MRI are ongoing. Conclusions: The Strat-AF study may be an essential step towards the exploration of the role of a combined clinical biomarker or multiple biomarker models in predicting stroke risk in AF, and might sustain the incorporation of such new markers in the existing stroke prediction schemes by the demonstration of a greater incremental value in predicting stroke risk and improvement in clinical outcomes in a cost-effective fashion.<\/jats:p>","DOI":"10.3390\/medicina55100626","type":"journal-article","created":{"date-parts":[[2019,9,23]],"date-time":"2019-09-23T11:02:00Z","timestamp":1569236520000},"page":"626","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Role of Biological Markers for Cerebral Bleeding Risk STRATification in Patients with Atrial Fibrillation on Oral Anticoagulants for Primary or Secondary Prevention of Ischemic Stroke (Strat-AF Study): Study Design and Methodology"],"prefix":"10.3390","volume":"55","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8694-0129","authenticated-orcid":false,"given":"Anna","family":"Poggesi","sequence":"first","affiliation":[{"name":"Stroke Unit, Careggi University Hospital, 50134 Florence, Italy"},{"name":"NEUROFARBA Department, Neuroscience Section, University of Florence, 50134 Florence, Italy"},{"name":"IRCCS Don Carlo Gnocchi, 50143 Florence, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4900-5008","authenticated-orcid":false,"given":"Carmen","family":"Barbato","sequence":"additional","affiliation":[{"name":"NEUROFARBA Department, Neuroscience Section, University of Florence, 50134 Florence, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1810-4222","authenticated-orcid":false,"given":"Francesco","family":"Galmozzi","sequence":"additional","affiliation":[{"name":"NEUROFARBA Department, Neuroscience Section, University of Florence, 50134 Florence, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eleonora","family":"Camilleri","sequence":"additional","affiliation":[{"name":"Department of Experimental and Clinical Medicine, University of Florence, 50134 Florence, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesca","family":"Cesari","sequence":"additional","affiliation":[{"name":"Central Laboratory, Careggi University Hospital, 50134 Florence, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefano","family":"Chiti","sequence":"additional","affiliation":[{"name":"Department Health Professions, U.O.c Research and Development, 50134 Careggi University Hospital, 50134 Florence, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefano","family":"Diciotti","sequence":"additional","affiliation":[{"name":"Department of Electrical, Electronic, and Information Engineering \u201cGuglielmo Marconi\u201d, University of Bologna, 40136 Bologna, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Silvia","family":"Galora","sequence":"additional","affiliation":[{"name":"Department of Experimental and Clinical Medicine, University of Florence, 50134 Florence, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Betti","family":"Giusti","sequence":"additional","affiliation":[{"name":"Department of Experimental and Clinical Medicine, University of Florence, 50134 Florence, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna Maria","family":"Gori","sequence":"additional","affiliation":[{"name":"Department of Experimental and Clinical Medicine, University of Florence, 50134 Florence, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1791-3573","authenticated-orcid":false,"given":"Chiara","family":"Marzi","sequence":"additional","affiliation":[{"name":"Department of Electrical, Electronic, and Information Engineering \u201cGuglielmo Marconi\u201d, University of Bologna, 40136 Bologna, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Melone","sequence":"additional","affiliation":[{"name":"NEUROFARBA Department, Neuroscience Section, University of Florence, 50134 Florence, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Damiano","family":"Mistri","sequence":"additional","affiliation":[{"name":"NEUROFARBA Department, Neuroscience Section, University of Florence, 50134 Florence, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesca","family":"Pescini","sequence":"additional","affiliation":[{"name":"Stroke Unit, Careggi University Hospital, 50134 Florence, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giovanni","family":"Pracucci","sequence":"additional","affiliation":[{"name":"NEUROFARBA Department, Neuroscience Section, University of Florence, 50134 Florence, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Valentina","family":"Rinnoci","sequence":"additional","affiliation":[{"name":"Stroke Unit, Careggi University Hospital, 50134 Florence, Italy"},{"name":"NEUROFARBA Department, Neuroscience Section, University of Florence, 50134 Florence, Italy"},{"name":"IRCCS Don Carlo Gnocchi, 50143 Florence, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cristina","family":"Sarti","sequence":"additional","affiliation":[{"name":"Stroke Unit, Careggi University Hospital, 50134 Florence, Italy"},{"name":"NEUROFARBA Department, Neuroscience Section, University of Florence, 50134 Florence, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Enrico","family":"Fainardi","sequence":"additional","affiliation":[{"name":"Neuroradiology Unit, Department of Experimental and Clinical Biomedical Sciences, University of Florence, Careggi University Hospital, 50134 Florence, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rossella","family":"Marcucci","sequence":"additional","affiliation":[{"name":"Department of Experimental and Clinical Medicine, University of Florence, 50134 Florence, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emilia","family":"Salvadori","sequence":"additional","affiliation":[{"name":"Stroke Unit, Careggi University Hospital, 50134 Florence, Italy"},{"name":"NEUROFARBA Department, Neuroscience Section, University of Florence, 50134 Florence, Italy"},{"name":"IRCCS Don Carlo Gnocchi, 50143 Florence, 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