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.
Přehled studie
Postavení
Podmínky
- Mozkový infarkt
- Trombóza mozkových žil
- Vaskulární demence (VaD)
- Intracerebrální krvácení (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
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Peter L. Kolominsky-Rabas, Univ.-Prof. Dr. med.
- Telefonní číslo: +49 9131 85-35855
- E-mail: peter.kolominsky-rabas@fau.de
Studijní místa
-
-
-
Erlangen, Německo, 91054
- Nábor
- Universitätsklinikum Erlangen
-
Erlangen, Německo, 91054
- Nábor
- Malteser Waldkrankenhaus St. Marien
-
Erlangen, Německo, 91056
- Nábor
- Klinikum am Europakanal
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
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.
Popis
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")
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: PROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
|---|
|
People with stroke
All individuals diagnosed with stroke (both hospitalized and non-hospitalized) |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Rod
Časové okno: Základní linie
|
Základní linie
|
|
|
Vzdělání
Časové okno: Základní linie
|
Základní linie
|
|
|
Postal code
Časové okno: Baseline
|
Baseline
|
|
|
Name
Časové okno: Baseline
|
Baseline
|
|
|
Address
Časové okno: Baseline
|
Baseline
|
|
|
Telephone number
Časové okno: Baseline
|
Baseline
|
|
|
Nationality
Časové okno: Baseline
|
Baseline
|
|
|
Employment status
Časové okno: 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
Časové okno: 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
|
|
|
Number of children
Časové okno: 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 health insurance company
Časové okno: 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
|
|
|
Length of residence in the study area
Časové okno: Baseline
|
Baseline
|
|
|
Telephone number of the General practitioner
Časové okno: 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
Časové okno: 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
|
|
|
Telephone number of the contact person
Časové okno: 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
Časové okno: 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
Časové okno: Baseline
|
as date |
Baseline
|
|
Date of death
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
|
National Institutes of Health Stroke Scale (NIHSS)
Časové okno: 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
Časové okno: 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
|
|
Mini-Mental State Examination (MMSE)
Časové okno: 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
Časové okno: 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
|
|
Medication
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
|
|
Diabetes mellitus
Časové okno: 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
|
|
Hypercholesterinemia
Časové okno: 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
|
|
TOAST-Classification
Časové okno: 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
|
|
Medical Outcomes Study Social Support Survey (MOS-SSS)
Časové okno: 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)
Časové okno: 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
|
|
Barthel Index
Časové okno: 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
|
|
Frenchay Activities Index (FAI)
Časové okno: 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
|
|
Functional Independence Measure (FIM)
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Cerebrovaskulární poruchy
- Onemocnění mozku
- Onemocnění centrálního nervového systému
- Nemoci nervového systému
- Cévní onemocnění
- Kardiovaskulární choroby
- Duševní poruchy
- Patologické procesy
- Neurokognitivní poruchy
- Krvácení
- Infarkt mozku
- Ischemie mozku
- Infarkt
- Nekróza
- Demence
- Embolie a trombóza
- Arterioskleróza
- Arteriální okluzivní onemocnění
- Ischemie
- Leukoencefalopatie
- Intrakraniální arterioskleróza
- Intrakraniální arteriální onemocnění
- Intrakraniální krvácení
- Intrakraniální embolie a trombóza
- Tromboembolismus
- Patologické stavy, příznaky a symptomy
- Mrtvice
- Mozkový infarkt
- Demence, Cévní
- Mozkové krvácení
- Demence, multiinfarkt
- Intrakraniální trombóza
Další identifikační čísla studie
- 249_15 Bc
- DRKS00040516 (Identifikátor registru: German Clinical Trials Register)
- ZMV I 1-2520KEU305 (Jiné číslo grantu/financování: German Federal Ministry of Health (BMG))
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu 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
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .