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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)

2026. szeptember 28. frissítette: University of Erlangen-Nürnberg Medical School

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.

A tanulmány áttekintése

Állapot

Toborzás

Körülmények

Tanulmány típusa

Megfigyelő

Beiratkozás (Becsült)

17000

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányi helyek

  • Németország
      • Erlangen, Németország, 91054
        • Toborzás
        • Universitätsklinikum Erlangen
      • Erlangen, Németország, 91054
        • Toborzás
        • Malteser Waldkrankenhaus St. Marien
      • Erlangen, Németország, 91056
        • Toborzás
        • Klinikum am Europakanal

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

18 év és régebbi (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

Mintavételi módszer

Nem valószínűségi minta

Tanulmányi populáció

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.

Leírás

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")

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Megfigyelési modellek: COHORT
  • Időperspektívák: PROSPECTIVE

Kohorszok és beavatkozások

Csoport / Kohorsz
People with stroke

All individuals diagnosed with stroke (both hospitalized and non-hospitalized)

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Nem
Időkeret: Alapvonal
Alapvonal
Oktatás
Időkeret: Alapvonal
Alapvonal
Postal code
Időkeret: Baseline
Baseline
Name
Időkeret: Baseline
Baseline
Address
Időkeret: Baseline
Baseline
Telephone number
Időkeret: Baseline
Baseline
Nationality
Időkeret: Baseline
Baseline
Employment status
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: Baseline
Baseline
Telephone number of the General practitioner
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: Baseline

as date
Baseline
Date of death
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: 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
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: 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)
Időkeret: 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
Időkeret: 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)
Időkeret: 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)
Időkeret: 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

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

University of Erlangen-Nürnberg Medical School

Publikációk és hasznos linkek

A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.

Hasznos linkek

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

1994. április 1.

Elsődleges befejezés (Becsült)

2094. március 30.

A tanulmány befejezése (Becsült)

2094. március 30.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. július 8.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. augusztus 13.

Első közzététel (Tényleges)

2026. augusztus 18.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. október 2.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. szeptember 28.

Utolsó ellenőrzés

2026. június 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • 249_15 Bc
  • DRKS00040516 (Registry Identifier: German Clinical Trials Register)
  • ZMV I 1-2520KEU305 (Egyéb támogatási/finanszírozási szám: German Federal Ministry of Health (BMG))

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

IGEN

IPD terv leírása

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

Gyógyszer- és eszközinformációk, tanulmányi dokumentumok

Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz

Nem

Egy amerikai FDA által szabályozott eszközterméket tanulmányoz

Nem

Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .

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