- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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). (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
Status
Conditions
- Cerebral Infarction
- Cerebral Vein Thrombosis
- Vascular Dementia (VaD)
- Intracerebral Haemorrhage (ICH)
- Cerebral Infarction Due to Thrombosis of Cerebral Arteries
- Cerebral Infarction Due to Embolism of Cerebral Arteries
- Stroke, Not Specified as Haemorrhage or Infarction
- Transient Cerebral Ischaemic Attacks and Related Syndromes
- Multi-infarct Dementia
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Peter L. Kolominsky-Rabas, Univ.-Prof. Dr. med.
- Phone Number: +49 9131 85-35855
- Email: peter.kolominsky-rabas@fau.de
Study Locations
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Erlangen, Germany, 91054
- Recruiting
- Universitätsklinikum Erlangen
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Erlangen, Germany, 91054
- Recruiting
- Malteser Waldkrankenhaus St. Marien
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Erlangen, Germany, 91056
- Recruiting
- Klinikum am Europakanal
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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People with stroke
All individuals diagnosed with stroke (both hospitalized and non-hospitalized)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Gender
Time Frame: Baseline
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Baseline
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Education
Time Frame: Baseline
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Baseline
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Postal code
Time Frame: Baseline
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Baseline
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Name
Time Frame: Baseline
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Baseline
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Address
Time Frame: Baseline
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Baseline
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Telephone number
Time Frame: Baseline
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Baseline
|
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Date of birth
Time Frame: Baseline
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as date
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Baseline
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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
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as date
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After 3 months, after 12 months, then annually until the event occurs. Currently there is a follow-up of 32 years-up
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Nationality
Time Frame: Baseline
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Baseline
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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
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Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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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
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Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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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
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Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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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
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Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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Length of residence in the study area
Time Frame: Baseline
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Baseline
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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
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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)
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Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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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
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Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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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
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Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
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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
|
|
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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
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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
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Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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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
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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)
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Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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(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
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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)
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Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
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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
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Total Score Range: 0-30, higher values indicate better cognitive performance
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Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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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
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Name of the drug
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Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
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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
|
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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
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Dose in milligrams per day
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Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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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
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Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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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
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yes/ no
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Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
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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
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yes/ no
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Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
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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
|
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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
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Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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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
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Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
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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
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Physical health and mental health summary scores, Total Score Range: 0-100, norm-based scoring, higher values indicate a better physical/mental health status
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Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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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
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Total Score Range: 0-100, higher values indicate better functional independence (less disability)
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Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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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
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Total Score Range: 15-60, higher values indicate better (greater) frequency/independence in instrumental activities of daily living (IADL)
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Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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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
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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)
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Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
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Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Mental Disorders
- Pathologic Processes
- Neurocognitive Disorders
- Hemorrhage
- Brain Infarction
- Brain Ischemia
- Infarction
- Necrosis
- Dementia
- Embolism and Thrombosis
- Arteriosclerosis
- Arterial Occlusive Diseases
- Ischemia
- Leukoencephalopathies
- Intracranial Arteriosclerosis
- Intracranial Arterial Diseases
- Intracranial Hemorrhages
- Intracranial Embolism and Thrombosis
- Thromboembolism
- Pathological Conditions, Signs and Symptoms
- Stroke
- Cerebral Infarction
- Dementia, Vascular
- Cerebral Hemorrhage
- Dementia, Multi-Infarct
- Intracranial Thrombosis
Other Study ID Numbers
- 249_15 Bc
- ZMV I 1-2520KEU305 (Other Grant/Funding Number: German Federal Ministry of Health)
- DRKS00040516 (Registry Identifier: German Clinical Trials Register)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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