- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07900230
The GEIR (Grupo español de Ictus Retina) Registry: Rationale and Design of the First Nationwide Multicentre Retinal Stroke Registry in Spain (GEIR)
Rationale and Design of the GEIR Registry: a Nationwide Multicentre Study of the Natural History, Epidemiological, Neurovascular, Imaging and Therapeutic Aspects of Retinal Stroke in Spain
Retinal stroke is a time-dependent neurovascular emergency associated with severe visual loss, increased risk of cerebrovascular events and substantial variability in clinical management.
The GEIR Registry is a nationwide, multicentre, ambispective observational registry comprising retrospective and prospective data collected from participating hospitals throughout Spain.
Aperçu de l'étude
Statut
Description détaillée
Despite growing recognition of retinal artery occlusion as the ocular equivalent of acute ischaemic stroke, important uncertainties remain regarding its epidemiology, pathophysiology, healthcare delivery, retinal viability and optimal treatment strategies. Current evidence is largely derived from retrospective cohorts, single-centre studies and a limited number of randomised clinical trials. Furthermore, no nationwide multicentre retinal stroke registry currently exists in Spain. The GEIR Registry was established to address these knowledge gaps through the creation of a national clinical and translational research platform dedicated to retinal stroke.
Methods and analysis The GEIR Registry is a nationwide, multicentre, ambispective observational registry comprising retrospective and prospective data collected from participating hospitals throughout Spain.
Consecutive patients presenting with retinal stroke, including central retinal artery occlusion, branch retinal artery occlusion, cilioretinal artery occlusion and paracentral acute middle maculopathy, are eligible for inclusion.
Clinical information is collected using a the institution's REDCap electronic data base specifically designed for the registry and includes demographic characteristics, vascular risk factors, acute stroke pathway metrics, neurovascular investigations, reperfusion therapies, laboratory biomarkers, secondary prevention strategies, neurological outcomes, ophthalmological assessments and longitudinal optical coherence tomography (OCT) biomarkers.
The registry aims to characterise retinal stroke epidemiology, healthcare delivery and long-term outcomes, while providing a unique platform for investigating retinal ischaemia, imaging biomarkers of retinal viability and predictors of visual recovery. Statistical analyses include descriptive epidemiological analyses, multivariable regression models and longitudinal outcome assessments.
Ethics and dissemination The registry will be conducted in accordance with the Declaration of Helsinki, applicable European and Spanish data protection regulations and local ethics committee approvals. Written informed consent will be obtained for prospective participants. Data will be pseudonymised and stored within a secure REDCap infrastructure.
Results generated from the registry will be disseminated through peer-reviewed publications, scientific conferences and collaborative multicentre research initiatives. The GEIR Registry is intended to serve as a long-term national infrastructure supporting clinical, epidemiological and translational research in retinal stroke.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Susana Ruiz-Bilbao, MD PhD
- Numéro de téléphone: 9 +34 93 4651200
- E-mail: sruizbilbao@gmail.com
Lieux d'étude
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Barcelona
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Badalona, Barcelona, Espagne, 08916
- Germans Trias
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
patients affected of retinal stroke
La description
Inclusion Criteria:
Age >18 years.
Clinical diagnosis of retinal stroke.
Symptom onset or last known normal vision within the previous 24 hours.
Absence of pre-existing ocular pathology severely limiting visual acuity in the affected eye.
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Exclusion Criteria:
- Patient with others diseases affecting retinal examination or retinal behaviour
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: OTHER
- Perspectives temporelles: OTHER
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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national research registry platform
Délai: 2026.12 - 2030.12
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To establish the first nationwide retinal stroke registry in Spain. |
2026.12 - 2030.12
|
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To estimate the epidemiological burden of retinal stroke.
Délai: 2026.12 - 2030.12
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To estimate the national epidemiological burden of retinal stroke in Spain. |
2026.12 - 2030.12
|
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To characterise healthcare pathways and access to reperfusion therapies.
Délai: 2026.12 - 2030.12
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To characterise national healthcare pathways and access to reperfusion therapies in Spain |
2026.12 - 2030.12
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To describe the natural history of retinal stroke.
Délai: 2026.12 - 2030.12
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Retinal stroke natural history in Spain |
2026.12 - 2030.12
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To identify clinical, neurovascular and imaging predictors of visual recovery.
Délai: 2026.12 - 2030.12
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searching imaging predictors of visual recovery |
2026.12 - 2030.12
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To investigate OCT biomarkers associated with retinal viability and treatment response. [CEIC GEIR HUGTiP | Word] and precise the time of retinal ischemia
Délai: 2026.12 - 2030.12
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searching OCT biomarkers of retinal viability |
2026.12 - 2030.12
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- Carnota-Mendez P, Remoli-Sargues L, Copete S, Fernandez-Vega-Gonzalezd A, Montero-Hernandez J, Zarranz-Ventura J, Alforja-Castiella MS, Renu-Jornet A, Doncel-Moriano A, Gomez-Ulla F, Ruiz-Bilbao S, Vieitez-Vazquez J, Mendez-Vazquez C, Blanco-Marchite C, Moreno-Martinez A, Sanchez-Maluf N, Olivier-Pascual N. Clinical Guidelines for the Diagnosis and Management of Retinal Artery Occlusions by the Spanish Society of Retina and Vitreous. Ophthalmologica. 2026;249(3):288-312. doi: 10.1159/000551309. Epub 2026 Mar 12.
- Bouchikh-El Jarroudi R, Valentin-Bravo FJ, Calatayud-Riera M, Ruiz-Bilbao S. Retinal stroke: A call to action for awareness and treatment of ocular vascular emergencies. Arch Soc Esp Oftalmol (Engl Ed). 2024 Sep;99(9):363-364. doi: 10.1016/j.oftale.2024.03.006. Epub 2024 Apr 24. No abstract available.
- Ruiz-Bilbao S, Bustamante A. Retina Stroke Code. A reality. Med Clin (Barc). 2024 Nov 15;163(9):458-460. doi: 10.1016/j.medcli.2024.05.024. Epub 2024 Aug 14. No abstract available. English, Spanish.
- Bustamante A, Balboa M, Ezcurra G, Sanchez-Fortun A, Ruiz J, Castellvi J, Castillo-Acedo S, Matas E, Bouchikh R, Martinez-Sanchez M, Castano C, Remollo S, Werner M, Salgado MC, Villodres S, Gea M, Millan M, Perez de la Ossa N, Ruiz-Bilbao S. Implementation of a retinal stroke-code protocol results in visual recovery in patients receiving reperfusion therapies. Eur Stroke J. 2024 Jun;9(2):486-493. doi: 10.1177/23969873231221366. Epub 2024 Jan 8.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- GEIR-2026 GrupoEspañolIctusRet
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
undecided
Informations sur les médicaments et les dispositifs, documents d'étude
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