NCT07771335

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17,000

participants targeted

Target at P75+ for all trials

Timeline
821mo left

Started Apr 1994

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Apr 1994Mar 2094

Study Start

First participant enrolled

April 1, 1994

Completed
32.3 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 18, 2026

Completed
67.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2094

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2094

Last Updated

October 2, 2026

Status Verified

June 1, 2026

Enrollment Period

100.1 years

First QC Date

July 8, 2026

Last Update Submit

September 28, 2026

Conditions

Keywords

StrokeErlangenGermanyRegistry

Outcome Measures

Primary Outcomes (36)

  • Name

    Baseline

  • Address

    Baseline

  • Postal code

    Baseline

  • Telephone number

    Baseline

  • Gender

    Baseline

  • Date of birth

    as date

    Baseline

  • Date of death

    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

    Baseline

  • Education

    Baseline

  • Employment 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

  • Marital 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

  • Number of children

    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

    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

    Baseline

  • Living arrangements

    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

    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

    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

    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

    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

    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)

    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

    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)

    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

    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

    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

    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)

    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

    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

    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

    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

    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)

    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)

    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

    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)

    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)

    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

Study Arms (1)

People with stroke

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Patients with transient episodes lasting less than 24 hours and those with asymptomatic lesions detected by brain imaging ("silent infarcts")

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Malteser Waldkrankenhaus St. Marien

Erlangen, 91054, Germany

RECRUITING

Universitätsklinikum Erlangen

Erlangen, 91054, Germany

RECRUITING

Klinikum am Europakanal

Erlangen, 91056, Germany

RECRUITING

Related Links

MeSH Terms

Conditions

Cerebral HemorrhageCerebral InfarctionStrokeDementia, VascularDementia, Multi-InfarctIntracranial Thrombosis

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsBrain InfarctionBrain IschemiaInfarctionIschemiaNecrosisIntracranial ArteriosclerosisIntracranial Arterial DiseasesDementiaLeukoencephalopathiesArteriosclerosisArterial Occlusive DiseasesNeurocognitive DisordersMental DisordersIntracranial Embolism and ThrombosisThromboembolismEmbolism and Thrombosis

Central Study Contacts

Peter L. Kolominsky-Rabas, Univ.-Prof. Dr. med.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2026

First Posted

August 18, 2026

Study Start

April 1, 1994

Primary Completion (Estimated)

March 30, 2094

Study Completion (Estimated)

March 30, 2094

Last Updated

October 2, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

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

Locations