- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02310282
Telemedicine for Optimized Collection of CLinical datA in Patients With Suspicion of Acute Stroke (TeleCLASS)
Descripción general del estudio
Descripción detallada
Assessment of stroke severity and differentiation between large-artery and small-artery stroke is pivotal for adequate treatment decision taking. Patients with small vessel stroke tend have a better prognosis than those with large artery disease. Further, patients with small artery infarction (lacunar stroke) have shown to respond well to treatment with intravenous recombinant tissue plasminogen activator (IV rt-PA), but are poor candidates for endovascular recanalization. Conversely, IV rt-PA may be less effective at restoring perfusion of large artery occlusion, a stroke subtype that may benefit from intra-arterial thrombolysis or embolectomy. Similarly, patients with large intracerebral hemorrhage or cerebellar hemorrhage may require neurosurgical interventions, such as intracranial pressure monitoring, ventricular drainage, surgical evacuation, or hemicraniectomy.
The purpose of TeleCLASS is to evaluate the discriminatory value of the Unassisted TeleStroke Scale (UTSS) obtained through in-hospital telemedicine for differentiation between patients with lacunar stroke and those with other acute stroke syndromes (nonLACS).
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Brussels, Bélgica, 1090
- Universitair Ziekenhuis Brussel
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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
Descripción
Inclusion criteria:
- Age > 18 years
- Suspicion of acute stroke with symptom onset < 72 h before teleconsultation
- NIHSS score > 0
- Informed consent
Exclusion criterion:
- Patients for whom telestroke consultation would delay any diagnostic or therapeutic intervention
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Telemedicine
In-hospital telemedicine by a stroke expert aiming to assess stroke severity using the Unassisted TeleStroke Scale.
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In-hospital telemedicine
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Predictive validity of the UTSS for patient classification between lacunar syndromes and other stroke syndromes based on the Oxfordshire Community Stroke Project classification.
Periodo de tiempo: within 3 days
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Receiver operating curves, c-statistics, optimal thresholds, likelihood ratios and accuracy measures (sensitivity, specificity, positive predictive value, negative predictive value and overall accuracy) will be calculated to evaluate the predictive ability of the UTSS for discrimination between lacunar syndrome (LACS) and other stroke syndromes (nonLACS)
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within 3 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Predictive validity of the UTSS for vessel status, classifying patients with acute ischemic stroke between those with large-artery occlusion and those without large-artery occlusion on imaging.
Periodo de tiempo: within 3 days
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Receiver operating curves, c-statistics, optimal thresholds, likelihood ratios and accuracy measures (sensitivity, specificity, positive predictive value, negative predictive value and overall accuracy) will be calculated to evaluate the predictive ability of the UTSS for discrimination between patients with large-artery occlusion and those without large-artery occlusion on imaging.
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within 3 days
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Predictive validity of the total UTSS score with cutoff value 6 for patient classification between lacunar syndromes and other stroke syndromes based on the Oxfordshire Community Stroke Project classification.
Periodo de tiempo: within 3 days
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Likelihood ratios and accuracy measures (sensitivity, specificity, positive predictive value, negative predictive value and overall accuracy) will be calculated to evaluate the predictive ability of the UTSS for discrimination between lacunar syndrome (LACS) and other stroke syndromes (nonLACS)
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within 3 days
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Jacques De Keyser, MD PhD, Universitair Ziekenhuis Brussel
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
- B.U.N. 143201010021
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