- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07771335
The Erlanger Stroke Registry (ESPro) is the Only Ongoing Prospective Population-based Stroke Registry in Germany, Started in 1994. ESPro Includes All Hospitalized and Non-hospitalized Patients With Stroke in the Community of Erlangen (120.000 Inhabitants), With a Long-life Follow-up. (ESPro)
The Erlangen Stroke Registry (ESPro)
Stroke is a disease that primarily affects older adults and, with an estimated 64,000 deaths in 2024, is one of the leading causes of death in Germany. Estimates of its prevalence and the burden of disease within the German population are therefore essential for calculating future healthcare needs and guide health policy planning. When the first stroke units (SU) began to emerge in Germany in 1994, health insurers raised the question of the total number of stroke patients requiring care. Unfortunately, at that time there were no reliable figures available to determine the nationwide need for stroke units. This marked the birth of the Erlangen Stroke Registry (ESPro).
For 32 years (1994-2026), ESPro has been continuously collecting data on the epidemiology, clinical course, and care of stroke and dementia, two of the most common diseases. The ESPro is designed as a regional, population-based registry that includes, as far as possible, all diagnosed strokes-that is, both hospitalized and non-hospitalized patients-regardless of age group or severity of the condition. Patients enrolled in the city of Erlangen undergo close monitoring of their clinical course and are followed up at intervals of 3 and 12 months, and then annually for the rest of their lives. This long-term follow-up enables comprehensive health services research on stroke, a widespread disease. Direct information on the course of the disease, its treatment, and care can be gleaned from registry data and incorporated into preventive medicine, treatment, and care planning.
Descripción general del estudio
Estado
Condiciones
- Infarto cerebral
- Trombosis de la vena cerebral
- Demencia Vascular (VaD)
- Hemorragia Intracerebral (HIC)
- Cerebral Infarction Due to Thrombosis of Cerebral Arteries
- Cerebral Infarction Due to Embolism of Cerebral Arteries
- Stroke, Not Specified as Haemorrhage or Infarction
- Transient Cerebral Ischaemic Attacks and Related Syndromes
- Multi-infarct Dementia
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Peter L. Kolominsky-Rabas, Univ.-Prof. Dr. med.
- Número de teléfono: +49 9131 85-35855
- Correo electrónico: peter.kolominsky-rabas@fau.de
Ubicaciones de estudio
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Erlangen, Alemania, 91054
- Reclutamiento
- Universitätsklinikum Erlangen
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Erlangen, Alemania, 91054
- Reclutamiento
- Malteser Waldkrankenhaus St. Marien
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Erlangen, Alemania, 91056
- Reclutamiento
- Klinikum am Europakanal
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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
The Erlangen Stroke Project (ESPro) is a community-based survey of all cases of stroke occurring in a university town, located in Bavaria in Southeast Germany. Several overlapping sources of information were used to ensure complete case ascertainment: (1) hospital admission and discharge lists and computer-linked records systems; (2) regular checks of all relevant hospital wards and residential and nursing homes; (3) records of ambulance and emergency services; (4) GPs; and (5) death certificates.
Descripción
Inclusion Criteria:
- All cases of stroke defined according to WHO criteria, as "rapidly developing clinical symptoms and/or signs of focal, and at times global, loss of cerebral function, with symptoms lasting more than 24 hours or leading to death, with no apparent cause other than that of vascular origin occurring in Erlangen, Bavaria
- No restrictions regarding age (provided they are of legal age), socioeconomic circumstance, stroke severity, or prior health status
Exclusion Criteria:
- Patients with transient episodes lasting less than 24 hours and those with asymptomatic lesions detected by brain imaging ("silent infarcts")
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
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People with stroke
All individuals diagnosed with stroke (both hospitalized and non-hospitalized) |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Género
Periodo de tiempo: Base
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Base
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Educación
Periodo de tiempo: Base
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Base
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Postal code
Periodo de tiempo: Baseline
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Baseline
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Name
Periodo de tiempo: Baseline
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Baseline
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Address
Periodo de tiempo: Baseline
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Baseline
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Telephone number
Periodo de tiempo: Baseline
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Baseline
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Nationality
Periodo de tiempo: Baseline
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Baseline
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Employment status
Periodo de tiempo: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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Marital status
Periodo de tiempo: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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Number of children
Periodo de tiempo: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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Name of the health insurance company
Periodo de tiempo: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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Length of residence in the study area
Periodo de tiempo: Baseline
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Baseline
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Telephone number of the General practitioner
Periodo de tiempo: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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Name of the contact person
Periodo de tiempo: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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Telephone number of the contact person
Periodo de tiempo: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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Relationship between the patient and the contact person
Periodo de tiempo: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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Date of birth
Periodo de tiempo: Baseline
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as date |
Baseline
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Date of death
Periodo de tiempo: After 3 months, after 12 months, then annually until the event occurs. Currently there is a follow-up of 32 years-up
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as date |
After 3 months, after 12 months, then annually until the event occurs. Currently there is a follow-up of 32 years-up
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Living arrangements
Periodo de tiempo: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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Which kind of living arrangement (own home environment, assisted living, nursing home) and who are the people, who live in this arrangement (alone, spouse, children, relatives, others) |
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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Assistance
Periodo de tiempo: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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yes/ no |
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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National Institutes of Health Stroke Scale (NIHSS)
Periodo de tiempo: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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Total Score Range: 0-42 (15 items, each scored on 3-5 point ordinal grades, 0 = normal), higher values indicate greater stroke severity (0 = no stroke symptoms, 1-4 minor, 5-15 moderate, 16-20 moderate-to-severe, 21-42 severe) |
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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(Modified) Rankin Scale
Periodo de tiempo: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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Total Score Range: 0-6 (7-point ordinal disability scale), higher values indicate worse (higher) disability (0 = no symptoms, 1 = no significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability, 6 = death) |
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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Mini-Mental State Examination (MMSE)
Periodo de tiempo: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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Total Score Range: 0-30, higher values indicate better cognitive performance |
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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Medication
Periodo de tiempo: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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Name of the drug |
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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Medication
Periodo de tiempo: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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Quantity |
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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Medication
Periodo de tiempo: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
Dose in milligrams per day |
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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Charlson Comorbidity Index (CCI)
Periodo de tiempo: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
Total Score Range: 0-33, higher values indicate a worse (greater) comorbid disease burden |
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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Hypertension
Periodo de tiempo: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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yes/ no |
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
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Diabetes mellitus
Periodo de tiempo: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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yes/ no |
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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Hypercholesterinemia
Periodo de tiempo: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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yes/ no |
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
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TOAST-Classification
Periodo de tiempo: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
Categorical etiologic classification system; it sorts ischemic stroke into 5 mutually exclusive subtype categories: (1) large-artery atherosclerosis, (2) cardioembolism, (3) small-vessel occlusion (lacunar), (4) stroke of other determined etiology, and (5) stroke of undetermined etiology |
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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Medical Outcomes Study Social Support Survey (MOS-SSS)
Periodo de tiempo: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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Total Score Range: Raw sum score: 19-95 (19 items, each rated on the 5-point frequency scale: 1 = none of the time … 5 = all of the time), Transformed index (0-100 scale), higher values indicate better (greater) perceived/available social support |
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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Short Form 36 Health Survey (SF-36)
Periodo de tiempo: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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Physical health and mental health summary scores, Total Score Range: 0-100, norm-based scoring, higher values indicate a better physical/mental health status |
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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Barthel Index
Periodo de tiempo: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
Total Score Range: 0-100, higher values indicate better functional independence (less disability) |
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
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Frenchay Activities Index (FAI)
Periodo de tiempo: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
Total Score Range: 15-60, higher values indicate better (greater) frequency/independence in instrumental activities of daily living (IADL) |
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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Functional Independence Measure (FIM)
Periodo de tiempo: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
Total Score Range: 18-126, Subscales: FIM-motor 13-91, FIM-cognitive 5-35, higher values indicate better (greater) functional independence (18 = total dependence, 126 = total independence) |
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
Términos MeSH relevantes adicionales
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Desordenes mentales
- Procesos Patológicos
- Trastornos neurocognitivos
- Hemorragia
- Infarto cerebral
- Isquemia cerebral
- Infarto
- Necrosis
- Demencia
- Embolia y Trombosis
- Arteriosclerosis
- Enfermedades arteriales oclusivas
- Isquemia
- Leucoencefalopatías
- Arteriosclerosis intracraneal
- Enfermedades Arteriales Intracraneales
- Hemorragias intracraneales
- Embolia intracraneal y trombosis
- Tromboembolismo
- Condiciones Patológicas, Signos y Síntomas
- Carrera
- Infarto cerebral
- Demencia Vascular
- Hemorragia cerebral
- Demencia Multiinfarto
- Trombosis intracraneal
Otros números de identificación del estudio
- 249_15 Bc
- DRKS00040516 (Identificador de registro: German Clinical Trials Register)
- ZMV I 1-2520KEU305 (Otro número de subvención/financiamiento: German Federal Ministry of Health (BMG))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Information on the use of research data from the Erlangen Stroke Registry can be found on the website at the following link: https://www.izph.fau.de/projekte/erlanger-schlaganfallregister/#angebot-zur-nutzung-von-forschungsdaten-aus-dem-erlanger-schlaganfallregister
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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