throMboembolic Risk Associated To High atrIal Fibrillation riSk
MATHIAS
Economic, Clinical, and Societal Impact of Early Thromboembolic -Risk Detection in High-Risk Atrial Fibrillation: A Model -Based Evaluation of the MATHIAS Strategy.
2 other identifiers
observational
1,000
1 country
1
Brief Summary
Cardiovascular diseases are the leading cause of mortality from treatable conditions in the European Union and the second from preventable causes, with a standardized mortality rate of 257.8 deaths per 100,000 inhabitants. In 2022, more than 1.11 million deaths in individuals under 75 years could have been avoided. Atrial fibrillation (AF) and major adverse cardiovascular events (MACE) are highly prevalent in the elderly and generate substantial healthcare costs. AF significantly increases the risk of MACE and is projected to rise markedly in the coming decades. In Europe, AF prevalence is expected to increase 2.5-fold over the next 50 years, with a lifetime risk of 1 in 3-5 individuals after age 55. AF-related strokes are projected to increase by 34%, and ischemic strokes in individuals over 80 are expected to triple between 2016 and 2060. Additionally, a 27% increase is anticipated among stroke survivors who subsequently develop AF or related conditions. AF substantially impacts morbidity, mortality, and disease progression, and early detection and treatment are crucial to prevent severe outcomes. European action plans (2018-2030) and the 2024 ESC/ESO guidelines emphasize early detection and management of AF in primary care. Although several AF prediction models exist, their integration into clinical practice remains challenging. AF represents a clinical continuum, with thrombotic risk present even before arrhythmia onset. High-risk patients for AF also show a high incidence of MACE, defined as a composite of myocardial infarction, stroke, systemic embolic events, and cardiovascular death. The proposed strategy involves developing and clinically validating an Artificial Intelligence (AI) model to improve early thrombotic risk prediction in patients at high risk of AF, using MACE as the primary outcome. This model aims to outperform the traditional CHA₂DS₂-VASc score by incorporating both classical and emerging clinical factors. The estimated timeline from clinical validation to commercialization is approximately 48 months. AI-based prediction is expected to enable personalized treatment, reduce the incidence of MACE, hospitalizations, and disability, and improve cost-effectiveness, ultimately decreasing the social and economic burden of AF and stroke in Europe.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2026
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2026
CompletedFirst Posted
Study publicly available on registry
March 2, 2026
CompletedStudy Start
First participant enrolled
July 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 29, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
March 2, 2026
February 1, 2026
1.3 years
February 20, 2026
February 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Primary Outcome Measures 1. Incidence of First-Ever and Recurrent Stroke
Annual rate of first-ever and recurrent stroke events per 100,000 inhabitants, measured using population-based registries and clinical records.
Through study completion, an average of 1 year
Major Adverse Cardiovascular Events (MACE)
Incidence of composite cardiovascular endpoint comprising myocardial infarction, stroke, extracranial systemic embolic events (SEEs), or cardiovascular death
Through study completion, an average of 1 year
Secondary Outcomes (3)
Early Detection of Atrial Fibrillation
Baseline and through study completion, an average of 1 year.
Systematic Bleeding Risk Assessment in Complex Chronic Patients
through study completion, an average of 1 year
Sex-Based Differences in Cardiovascular Care and Outcomes
Through study completion, an average of 1 year
Other Outcomes (2)
Post-Stroke Healthcare and Socio-Healthcare Costs
From the index stroke to 12 months post-event
Preventable Cardiovascular Hospitalizations
Through study completion, an average of 1 year
Study Arms (1)
control
Usual care (comparator): Opportunistic AF detection during routine clinical encounters and anticoagulation guided by the CHA₂DS₂VA score in patients with documented AF, without any AI-based pre-AF risk assessment. This approach reflects current guideline-concordant practice in many European primary care settings, where AF digital screening has not yet been implemented.
Interventions
MATHIAS-guided strategy (intervention): This approach was applied to the high-risk cohort (Q4) \[10,24\] to estimate individual thromboembolic risk. The process included a subsequent clinical evaluation and device-based photoplethysmography screening \[5,11\], followed by AI-driven thromboembolic risk stratification using the MATHIAS AI prototype \[35,36\] with initiation of oral anticoagulation according to the predicted risk profile, regardless of whether atrial fibrillation was confirmed or not.
Eligibility Criteria
This study will use routinely collected data from the SAP Terres de l'Ebre primary-care database (Catalonia, Spain) covering 178,112 inhabitants (49.6% women) managed in 11 primary-care health centers. The region is characterized by advanced population aging \[19\] (aging index 159.5 vs 131.3 in Catalonia and 118.4 in Spain) and lower average per-capita income \[20\] (77.4% of the Catalan mean). Adults aged 65-95 years without prior AF and with active records in the HCC3/CMBD systems at baseline. This cohort is characterized by multimorbidity and high-predicted risk of AF and related complications reflecting patients typically managed in primary care in European health systems, providing a real-world setting with high cardiovascular burden and constrained resources.
You may qualify if:
- Adults aged 65-95 years without prior AF and at High risk of AF, according to the risk score validated in the AFRICAT (Atrial Fibrilation Research in CATalonia) study. This scale considers the following variables for risk calculation: sex, age, weight, cardiac rate and CHA2DS2-VASc (congestive heart failure, hypertension, age ≥75 (doubled), diabetes mellitus, prior stroke or transient ischemic attack (doubled), vascular disease, age 65-74, female) score.
- with active records in the HCC3/CMBD systems
- CHA2DS2-VASc score≥2.
- Ability to use a smart phone (or at least the caregiver).
You may not qualify if:
- Previous diagnosis of AF.
- Previous diagnosis of stroke.
- Severe cognitive impairment, with a score on the Global Deterioration Scale (GDS)≥3.
- Severe functional impairment, with a Barthel score ≤60, or modified Rankin score≥4.
- Vital prognosis less than 1 year.
- Pacemaker carriers.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
EAP Tortose est. Servei d'Atencio Primaria i Comunitària. Institut Catala de la Salit
Tortosa, Tarragona, 43500, Spain
Related Publications (4)
Lorman-Carbo B, Clua-Espuny JL, Muria-Subirats E, Ballesta-Ors J, Gonzalez-Henares MA, Fernandez-Saez J, Martin-Lujan FM; on behalf Ebrictus Research Group. Complex chronic patients as an emergent group with high risk of intracerebral haemorrhage: an observational cohort study. BMC Geriatr. 2021 Feb 5;21(1):106. doi: 10.1186/s12877-021-02004-4.
PMID: 33546615RESULTPala E, Bustamante A, Clua-Espuny JL, Acosta J, Gonzalez-Loyola F, Santos SD, Ribas-Segui D, Ballesta-Ors J, Penalba A, Giralt M, Lechuga-Duran I, Gentille-Lorente D, Pedrote A, Munoz MA, Montaner J. Blood-biomarkers and devices for atrial fibrillation screening: Lessons learned from the AFRICAT (Atrial Fibrillation Research In CATalonia) study. PLoS One. 2022 Aug 23;17(8):e0273571. doi: 10.1371/journal.pone.0273571. eCollection 2022.
PMID: 35998199RESULTHernandez-Pinilla A, Clua-Espuny JL, Satue-Gracia EM, Palleja-Millan M, Martin-Lujan FM; PREFA-TE Study-Group. Protocol for a multicentre and prospective follow-up cohort study of early detection of atrial fibrillation, silent stroke and cognitive impairment in high-risk primary care patients: the PREFA-TE study. BMJ Open. 2024 Feb 19;14(2):e080736. doi: 10.1136/bmjopen-2023-080736.
PMID: 38373864RESULTClua-Espuny JL, Hernandez-Pinilla A, Gentille-Lorente D, Muria-Subirats E, Forcadell-Arenas T, de Diego-Cabanes C, Ribas-Segui D, Diaz-Vilarasau A, Molins-Rojas C, Palleja-Millan M, Satue-Gracia EM, Martin-Lujan F; PREFATE Project-Group. Evidence Gaps and Lessons in the Early Detection of Atrial Fibrillation: A Prospective Study in a Primary Care Setting (PREFATE Study). Biomedicines. 2025 Jan 7;13(1):119. doi: 10.3390/biomedicines13010119.
PMID: 39857703RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Josep Clua-Espuny, PhD
FUNDACIO INSTITUT UNIVERSITARI PERA LA RECERCA A L'ATENCIO PRIMARIA DE SALUT JORDI GOL I GURINA
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
February 20, 2026
First Posted
March 2, 2026
Study Start
July 6, 2026
Primary Completion (Estimated)
October 29, 2027
Study Completion (Estimated)
December 31, 2028
Last Updated
March 2, 2026
Record last verified: 2026-02