The Erlanger Stroke Project is an Ongoing Prospective Population-based Stroke Registry in Germany, Including All Hospitalized and Nonhospitalized Patients With Stroke in the City of Erlangen (120.000 Inhabitants). (ESPro)

The Erlangen Stroke Project (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.

Study Overview

Study Type

Observational

Enrollment (Estimated)

17000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Erlangen, Germany, 91054
        • Recruiting
        • Universitätsklinikum Erlangen
      • Erlangen, Germany, 91054
        • Recruiting
        • Malteser Waldkrankenhaus St. Marien
      • Erlangen, Germany, 91056
        • Recruiting
        • Klinikum am Europakanal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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")

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
People with stroke
All individuals diagnosed with stroke (both hospitalized and non-hospitalized)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gender
Time Frame: Baseline
Baseline
Education
Time Frame: Baseline
Baseline
Postal code
Time Frame: Baseline
Baseline
Name
Time Frame: Baseline
Baseline
Address
Time Frame: Baseline
Baseline
Telephone number
Time Frame: Baseline
Baseline
Date of birth
Time Frame: Baseline
as date
Baseline
Date of death
Time Frame: 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
Nationality
Time Frame: Baseline
Baseline
Employment status
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Baseline
Baseline
Living arrangements
Time Frame: 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
Telephone number of the General practitioner
Time Frame: 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
Assistance
Time Frame: 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
Name of the contact person
Time Frame: 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
Time Frame: 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
Time Frame: 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
National Institutes of Health Stroke Scale (NIHSS)
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 1994

Primary Completion (Estimated)

March 30, 2094

Study Completion (Estimated)

March 30, 2094

Study Registration Dates

First Submitted

July 8, 2026

First Submitted That Met QC Criteria

August 13, 2026

First Posted (Actual)

August 18, 2026

Study Record Updates

Last Update Posted (Actual)

August 18, 2026

Last Update Submitted That Met QC Criteria

August 13, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe