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Intracerebral Haemorrhage (ICH)ESProNCT07771335

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.

An observational study of Intracerebral Haemorrhage (ICH) and Cerebral Infarction, run by University of Erlangen-Nürnberg Medical School at 3 sites in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
How many people
17,000 participants
Where
3 sitesGermany
Study dates
1 Apr 1994to 30 Mar 2094
How long will I take part?
30 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

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

+49 9131 85-35855

peter.kolominsky-rabas@fau.de

Germany3 sites, 3 recruiting
  • Malteser Waldkrankenhaus St. Marien

    Erlangen, 91054

    Recruiting
  • Universitätsklinikum Erlangen

    Erlangen, 91054

    Recruiting
  • Klinikum am Europakanal

    Erlangen, 91056

    Recruiting

Other trials in Germany

About this study

Official title: 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.

Keywords
Stroke, Erlangen, Germany, Registry
Medical subject headings
Cerebral Hemorrhage, Cerebral Infarction, Stroke, Dementia, Vascular, Dementia, Multi-Infarct, Intracranial Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07771335
Study groupRoleWhat they receive
People with strokeAll individuals diagnosed with stroke (both hospitalized and non-hospitalized)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Name

    Measured: Baseline

  2. Address

    Measured: Baseline

  3. Postal code

    Measured: Baseline

  4. Telephone number

    Measured: Baseline

  5. Gender

    Measured: Baseline

  6. Date of birth

    as date

    Measured: Baseline

  7. Date of death

    as date

    Measured: After 3 months, after 12 months, then annually until the event occurs. Currently there is a follow-up of 32 years-up

  8. Nationality

    Measured: Baseline

  9. Education

    Measured: Baseline

  10. Employment status

    Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years

  11. Marital status

    Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years

  12. Number of children

    Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years

  13. Name of the health insurance company

    Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years

  14. Length of residence in the study area

    Measured: Baseline

  15. 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)

    Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years

  16. Telephone number of the General practitioner

    Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years

  17. Assistance

    yes/ no

    Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years

  18. Name of the contact person

    Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years

  19. Telephone number of the contact person

    Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years

  20. Relationship between the patient and the contact person

    Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years

  21. 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)

    Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years

  22. (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)

    Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years

  23. Mini-Mental State Examination (MMSE)

    Total Score Range: 0-30, higher values indicate better cognitive performance

    Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years

  24. Medication

    Name of the drug

    Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years

  25. Medication

    Quantity

    Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years

  26. Medication

    Dose in milligrams per day

    Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years

  27. Charlson Comorbidity Index (CCI)

    Total Score Range: 0-33, higher values indicate a worse (greater) comorbid disease burden

    Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years

  28. Hypertension

    yes/ no

    Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years

  29. Diabetes mellitus

    yes/ no

    Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years

  30. Hypercholesterinemia

    yes/ no

    Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years

  31. 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

    Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years

  32. 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

    Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years

  33. 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

    Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years

  34. Barthel Index

    Total Score Range: 0-100, higher values indicate better functional independence (less disability)

    Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years

  35. Frenchay Activities Index (FAI)

    Total Score Range: 15-60, higher values indicate better (greater) frequency/independence in instrumental activities of daily living (IADL)

    Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years

  36. 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)

    Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2026
  2. Study start1 Apr 1994
  3. Primary completion30 Mar 2094 (estimated)
  4. Study completion30 Mar 2094 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
17,000 participants (estimated)
Target duration
30 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07771335
Sponsor's protocol ID
249_15 Bc
Other IDs
ZMV I 1-2520KEU305, DRKS00040516
Acronym
ESPro
Status last verified
Jun 2026
First submitted
8 Jul 2026
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

An observational study of Intracerebral Haemorrhage (ICH) and Cerebral Infarction, run by University of Erlangen-Nürnberg Medical School at 3 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Peter L. Kolominsky-Rabas, Univ.-Prof. Dr. med. (+49 9131 85-35855, peter.kolominsky-rabas@fau.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Name (time frame: Baseline). The study lists 36 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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