- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
- Cerebral infarkt
- Cerebral Ven Trombos
- Vaskulär demens (VaD)
- Intracerebral blödning (ICH)
- 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
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Peter L. Kolominsky-Rabas, Univ.-Prof. Dr. med.
- Telefonnummer: +49 9131 85-35855
- E-post: peter.kolominsky-rabas@fau.de
Studieorter
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-
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Erlangen, Tyskland, 91054
- Rekrytering
- Universitätsklinikum Erlangen
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Erlangen, Tyskland, 91054
- Rekrytering
- Malteser Waldkrankenhaus St. Marien
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Erlangen, Tyskland, 91056
- Rekrytering
- Klinikum am Europakanal
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
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.
Beskrivning
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")
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
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People with stroke
All individuals diagnosed with stroke (both hospitalized and non-hospitalized) |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Kön
Tidsram: Baslinje
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Baslinje
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Utbildning
Tidsram: Baslinje
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Baslinje
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Postal code
Tidsram: Baseline
|
Baseline
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Name
Tidsram: Baseline
|
Baseline
|
|
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Address
Tidsram: Baseline
|
Baseline
|
|
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Telephone number
Tidsram: Baseline
|
Baseline
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Nationality
Tidsram: Baseline
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Baseline
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|
Employment status
Tidsram: 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
|
|
|
Marital status
Tidsram: 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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Number of children
Tidsram: 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
Tidsram: 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
Tidsram: Baseline
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Baseline
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Telephone number of the General practitioner
Tidsram: 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
|
|
|
Name of the contact person
Tidsram: 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
Tidsram: 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
|
|
|
Relationship between the patient and the contact person
Tidsram: 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
|
|
|
Date of birth
Tidsram: Baseline
|
as date |
Baseline
|
|
Date of death
Tidsram: After 3 months, after 12 months, then annually until the event occurs. Currently there is a follow-up of 32 years-up
|
as date |
After 3 months, after 12 months, then annually until the event occurs. Currently there is a follow-up of 32 years-up
|
|
Living arrangements
Tidsram: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
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
|
|
Assistance
Tidsram: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
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)
Tidsram: 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: 0-42 (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
|
|
(Modified) Rankin Scale
Tidsram: 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: 0-6 (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)
Tidsram: 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: 0-30, 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
|
|
Medication
Tidsram: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
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
Tidsram: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
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
|
|
Medication
Tidsram: 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
|
|
Charlson Comorbidity Index (CCI)
Tidsram: 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
|
|
Hypertension
Tidsram: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
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
Tidsram: 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
Tidsram: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
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
Tidsram: 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)
Tidsram: 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: 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
|
|
Short Form 36 Health Survey (SF-36)
Tidsram: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
|
Samarbetspartners och utredare
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Cerebrovaskulära störningar
- Hjärnsjukdomar
- Sjukdomar i centrala nervsystemet
- Sjukdomar i nervsystemet
- Kärlsjukdomar
- Hjärt-kärlsjukdomar
- Mentala störningar
- Patologiska processer
- Neurokognitiva störningar
- Blödning
- Hjärninfarkt
- Hjärnischemi
- Infarkt
- Nekros
- Demens
- Embolism och trombos
- Arterioskleros
- Arteriella ocklusiva sjukdomar
- Ischemi
- Leukoencefalopati
- Intrakraniell arterioskleros
- Intrakraniella arteriella sjukdomar
- Intrakraniella blödningar
- Intrakraniell emboli och trombos
- Tromboembolism
- Patologiska tillstånd, tecken och symtom
- Stroke
- Cerebral infarkt
- Demens, Vaskulär
- Hjärnblödning
- Demens, multiinfarkt
- Intrakraniell trombos
Andra studie-ID-nummer
- 249_15 Bc
- DRKS00040516 (Registeridentifierare: German Clinical Trials Register)
- ZMV I 1-2520KEU305 (Annat bidrag/finansieringsnummer: German Federal Ministry of Health (BMG))
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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
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