The Erlangen Stroke Project (ESPro)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 17,000
- 试验地点
- 3
- 主要终点
- Name
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients with transient episodes lasting less than 24 hours and those with asymptomatic lesions detected by brain imaging ("silent infarcts")
结局指标
主要结局
Name
时间窗: Baseline
Address
时间窗: Baseline
Postal code
时间窗: Baseline
Telephone number
时间窗: Baseline
Gender
时间窗: Baseline
Date of birth
时间窗: Baseline
as date
Date of death
时间窗: After 3 months, after 12 months, then annually until the event occurs. Currently there is a follow-up of 32 years-up
as date
Nationality
时间窗: Baseline
Education
时间窗: Baseline
Employment status
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Baseline
Living arrangements
时间窗: 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)
Telephone number of the General practitioner
时间窗: 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
时间窗: 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
Name of the contact person
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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)
(Modified) Rankin Scale
时间窗: 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)
Mini-Mental State Examination (MMSE)
时间窗: 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
Medication
时间窗: 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
Charlson Comorbidity Index (CCI)
时间窗: 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
Hypertension
时间窗: 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
Diabetes mellitus
时间窗: 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
Hypercholesterinemia
时间窗: 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
TOAST-Classification
时间窗: 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
Medical Outcomes Study Social Support Survey (MOS-SSS)
时间窗: 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
Short Form 36 Health Survey (SF-36)
时间窗: 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
Barthel Index
时间窗: 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)
Frenchay Activities Index (FAI)
时间窗: 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)
Functional Independence Measure (FIM)
时间窗: 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)
次要结局
未报告次要终点