此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

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. (ESPro)

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.

研究概览

研究类型

观察性的

注册 (估计的)

17000

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Erlangen、德国、91054
        • 招聘中
        • Universitätsklinikum Erlangen
      • Erlangen、德国、91054
        • 招聘中
        • Malteser Waldkrankenhaus St. Marien
      • Erlangen、德国、91056
        • 招聘中
        • Klinikum am Europakanal

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

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.

描述

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")

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:COHORT
  • 时间观点:PROSPECTIVE

队列和干预

团体/队列
People with stroke

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

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
性别
大体时间:基线
基线
教育
大体时间:基线
基线
Postal code
大体时间:Baseline
Baseline
Name
大体时间:Baseline
Baseline
Address
大体时间:Baseline
Baseline
Telephone number
大体时间:Baseline
Baseline
Nationality
大体时间:Baseline
Baseline
Employment status
大体时间: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
Marital status
大体时间: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
Number of children
大体时间: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
Name of the health insurance company
大体时间: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
Length of residence in the study area
大体时间:Baseline
Baseline
Telephone number of the General practitioner
大体时间: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
Name of the contact person
大体时间: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
Telephone number of the contact person
大体时间: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
Relationship between the patient and the contact person
大体时间: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
Date of birth
大体时间:Baseline

as date

Baseline
Date of death
大体时间:After 3 months, after 12 months, then annually until the event occurs. Currently there is a follow-up of 32 years-up

as date

After 3 months, after 12 months, then annually until the event occurs. Currently there is a follow-up of 32 years-up
Living arrangements
大体时间: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)

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
大体时间: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
National Institutes of Health Stroke Scale (NIHSS)
大体时间: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)

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
大体时间: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)

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)
大体时间: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

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
大体时间: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

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
大体时间: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
Medication
大体时间: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

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)
大体时间: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

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
大体时间: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
Diabetes mellitus
大体时间: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
Hypercholesterinemia
大体时间: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
TOAST-Classification
大体时间: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

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)
大体时间: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

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)
大体时间: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

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
大体时间: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)

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)
大体时间: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)

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)
大体时间: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)

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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

1994年4月1日

初级完成 (估计的)

2094年3月30日

研究完成 (估计的)

2094年3月30日

研究注册日期

首次提交

2026年7月8日

首先提交符合 QC 标准的

2026年8月13日

首次发布 (实际的)

2026年8月18日

研究记录更新

最后更新发布 (实际的)

2026年10月2日

上次提交的符合 QC 标准的更新

2026年9月28日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

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

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅