- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Susana Ruiz-Bilbao, MD PhD
- Número de teléfono: 9 +34 93 4651200
- Correo electrónico: sruizbilbao@gmail.com
Ubicaciones de estudio
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Barcelona
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Badalona, Barcelona, España, 08916
- Germans Trias
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
patients affected of retinal stroke
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: OTHER
- Perspectivas temporales: OTHER
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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national research registry platform
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: 2026.12 - 2030.12
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searching OCT biomarkers of retinal viability |
2026.12 - 2030.12
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GEIR-2026 GrupoEspañolIctusRet
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
undecided
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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