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NCT Number: NCT07771335

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).

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.

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Key information

Conditions

Intracerebral Haemorrhage (ICH) Arterial Occlusive Diseases Arteriosclerosis Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebral Infarction Cerebral Infarction Due to Embolism of Cerebral Arteries Cerebral Infarction Due to Thrombosis of Cerebral Arteries Cerebral Vein Thrombosis Cerebrovascular Disorders Dementia Dementia, Multi-Infarct Dementia, Vascular Embolism and Thrombosis Hemorrhage Infarction Intracranial Arterial Diseases Intracranial Arteriosclerosis Intracranial Embolism and Thrombosis Intracranial Hemorrhages Intracranial Thrombosis Ischemia Leukoencephalopathies Mental Disorders Multi-Infarct Dementia Necrosis Nervous System Diseases Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Stroke, Not Specified as Haemorrhage or Infarction Thromboembolism Transient Cerebral Ischaemic Attacks and Related Syndromes Vascular Dementia (VaD) Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum am Europakanal, Erlangen, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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")

Treatment and study plan

Primary outcomes

  1. Name

    Time frame: Baseline

  2. Address

    Time frame: Baseline

  3. Postal code

    Time frame: Baseline

  4. Telephone number

    Time frame: Baseline

  5. Gender

    Time frame: Baseline

  6. Date of birth

    Time frame: Baseline

    as date

  7. 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

  8. Nationality

    Time frame: Baseline

  9. Education

    Time frame: Baseline

  10. 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

  11. 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

  12. 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

  13. 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

  14. Length of residence in the study area

    Time frame: Baseline

  15. 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)

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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)

  22. (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)

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. 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

  32. 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

  33. 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

  34. 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)

  35. 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)

  36. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+49 9131 85-35855

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study title

The Erlangen Stroke Project (ESPro)

Acronym: ESPro

Important dates

Study start
1994
Primary completion
2094
Study completion
2094
First posted
Aug 18, 2026
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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