BMJ open · 2025
Using virtual twin-based AI models to detect atrial fibrillation and improve stroke outcomes [TAILOR]: a multicentre prospective cohort study.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод пока не подготовлен
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van Kempen Evi J, Jiménez-Balado Joan, Jiménez-Conde Jordi, Meijer Frederick Jan Anton, Ten Cate Tim Jf, Palacio-Gili Abel, Ortega-Martorell Sandra, Beltran Marmol Brigitte, Tuladhar Anil, Giralt-Steinhauer Eva, TARGET Consortium
Аннотация
INTRODUCTION: Atrial fibrillation (AF) is the leading cause of cardioembolic stroke and is associated with increased stroke severity and fatality. Early identification of AF is essential for adequate secondary prevention but remains challenging due to its often asymptomatic or paroxysmal occurrence. Artificial intelligence (AI) offers new possibilities by integrating biomarkers, clinical phenotypes, established risk factors and imaging features to define a personalised 'digital twin' model. The TAILOR study aims to (1) examine prospective detection of AF using monitoring devices, (2) investigate novel prognostic MRI markers in patients with an AF-related stroke (AFRS) and (3) validate AI-based models for outcome prediction in AFRS.
METHODS AND ANALYSIS: This prospective multicentre observational cohort study includes patients aged 40 years and above, with neuroimaging-confirmed diagnosis of ischaemic stroke, recruited from two sites: Hospital del Mar Barcelona (Spain) and Radboud University Medical Centre (The Netherlands). For the first sub-study (n=300), patients will undergo clinical assessment at baseline, 3 months and 12 months, and patch-based or Holter cardiac monitoring. The second sub-study (n=200) involves repeated brain MRI and cognitive examination after AFRS. Finally, AI-driven 'digital twin' models developed on retrospective TARGET datasets will be prospectively evaluated in TAILOR using temporal and centre-stratified analyses for advanced predictive tools for AF and AFRS outcomes.
ETHICS AND DISSEMINATION: The TAILOR study was approved by local ethics boards in Barcelona (CPMP/ICH/135/95) and Medical Research Ethics Committee Oost-Nederland (NL86346.091.24). Patients will be included after providing informed consent. Study results will be presented in peer-reviewed journals and at global conferences.
METHODS AND ANALYSIS: This prospective multicentre observational cohort study includes patients aged 40 years and above, with neuroimaging-confirmed diagnosis of ischaemic stroke, recruited from two sites: Hospital del Mar Barcelona (Spain) and Radboud University Medical Centre (The Netherlands). For the first sub-study (n=300), patients will undergo clinical assessment at baseline, 3 months and 12 months, and patch-based or Holter cardiac monitoring. The second sub-study (n=200) involves repeated brain MRI and cognitive examination after AFRS. Finally, AI-driven 'digital twin' models developed on retrospective TARGET datasets will be prospectively evaluated in TAILOR using temporal and centre-stratified analyses for advanced predictive tools for AF and AFRS outcomes.
ETHICS AND DISSEMINATION: The TAILOR study was approved by local ethics boards in Barcelona (CPMP/ICH/135/95) and Medical Research Ethics Committee Oost-Nederland (NL86346.091.24). Patients will be included after providing informed consent. Study results will be presented in peer-reviewed journals and at global conferences.