DEDEMASDeterminants of Dementia After Stroke
Colección de datos
Recopilados desde hoy en adelante - ProspectivoEnfermedades Oclusivas Arteriales+16
+ Isquemia cerebral
+ Trastornos Cerebrovasculares
Cohorte
Seguimiento de la incidencia de una enfermedad para identificar factores de riesgo y comprender su progresión a lo largo del tiempo.Resumen
Fecha de inicio: 1 de abril de 2011
Fecha en la que se inscribió al primer participante.Risk of dementia is high after stroke but the mechanisms of post stroke dementia (PSD) are insufficiently understood. Specifically, there are few data on how vascular and neurodegenerative mechanisms interact in determining cognitive decline after stroke. The primary aim of the DEDEMAS/DEMDAS (Determinants of Dementia After Stroke) study is to identify predictors of PSD. A particular focus will be on biological markers (neuroimaging, biochemical markers derived from blood) and on interactions between vascular and neurodegenerative mechanisms. Patients with an acute stroke and without prior dementia will be followed for 5 years with assessments at baseline (< 72 h after onset of stroke), and at 3, 6, 12, 24, 36, 48, and 60 months. In addition, DEDEMAS patients will have an annual telephone follow-up from year 6 to 10. Baseline assessments will include variables previously demonstrated to be associated with PSD as well as novel variables. Brain MRI (structural MRI and resting state fMRI) in combination with detailed neuropsychological testing and blood draws will be done at 6, 12, 36, and 60 months. Patients developing cognitive impairment (with or without dementia) and a subgroup of matched individuals without cognitive decline will be examined by brain FDG-PET and Amyloid-PET scanning. Lumbar puncture will be done on patients who develop cognitive impairment and thus have a clinical indication for the procedure. Efforts will be made to classify demented patients into diagnostic categories (Vascular Dementia, Mixed Dementia, Alzheimer's disease, other categories). Predictive factors for PSD will be identified using multiple Cox-proportional hazards models. Apart from providing insights into the mechanisms of PSD this study holds the potential to identify novel diagnostic markers and novel targets for preventive therapies.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 736 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Cohorte
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: * Age ≥ 18 years * Language: German * Acute stroke that occurred within the last 5 days as defined by: acute focal neurological deficit in combination with one of the following: * An acute ischemic infarct as documented by either a DWI positive lesion on MR imaging or a new lesion on a delayed CT scan * An intracerebral hemorrhage as documented on CT or MRI * An informant of the patient is available * Written informed consent by patient prior to study participation * Willingness to participate in follow-up Exclusion Criteria: * IQCODE \> 64 or diagnosis of dementia * Patients transferred from an outside stroke unit (to avoid possible selection bias) * Patients presenting a stroke going back more than 120 hours * Patients presenting one of the following diseases: cerebral venous thrombosis, traumatic cerebral haemorrhage, intracerebral haemorrhage because of a known or image-guided assumed vascular malformation, pure meningeal or intraventricular haemorrhage * Patients presenting a malignant disease with life expectancy \< 3years * Contraindication for MRI * Participation in an intervention/AMG-study at baseline
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Objetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 5 ubicaciones
DZNE/Munich-Interdisciplinary Stroke Center Munich, Klinikum der Universität München, Campus Großhadern
Munich, GermanyAbrir DZNE/Munich-Interdisciplinary Stroke Center Munich, Klinikum der Universität München, Campus Großhadern en Google MapsDZNE/Berlin - Neuroscience Research Center - Campus Mitte Charité
Berlin, GermanyDZNE/Bonn - Klinik und Poliklinik für Neurologie, Universitätsklinikum Bonn
Bonn, GermanyDZNE/Göttingen - University Medical Center Göttingen
Göttingen, Germany