- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Susana Ruiz-Bilbao, MD PhD
- Telefonnummer: 9 +34 93 4651200
- E-post: sruizbilbao@gmail.com
Studiesteder
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Barcelona
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Badalona, Barcelona, Spania, 08916
- Germans Trias
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
patients affected of retinal stroke
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: OTHER
- Tidsperspektiver: OTHER
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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national research registry platform
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 2026.12 - 2030.12
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searching OCT biomarkers of retinal viability |
2026.12 - 2030.12
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- GEIR-2026 GrupoEspañolIctusRet
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
undecided
Legemiddel- og utstyrsinformasjon, studiedokumenter
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