- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07771335
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.
연구 개요
상태
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Peter L. Kolominsky-Rabas, Univ.-Prof. Dr. med.
- 전화번호: +49 9131 85-35855
- 이메일: peter.kolominsky-rabas@fau.de
연구 장소
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Erlangen, 독일, 91054
- 모병
- Universitätsklinikum Erlangen
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Erlangen, 독일, 91054
- 모병
- Malteser Waldkrankenhaus St. Marien
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Erlangen, 독일, 91056
- 모병
- Klinikum am Europakanal
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
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")
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
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People with stroke
All individuals diagnosed with stroke (both hospitalized and non-hospitalized) |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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성별
기간: 기준선
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기준선
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교육
기간: 기준선
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기준선
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Postal code
기간: Baseline
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Baseline
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Name
기간: Baseline
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Baseline
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Address
기간: Baseline
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Baseline
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Telephone number
기간: Baseline
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Baseline
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Nationality
기간: Baseline
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Baseline
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Employment status
기간: 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
기간: 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
기간: 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
기간: 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
기간: Baseline
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Baseline
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Telephone number of the General practitioner
기간: 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 contact person
기간: 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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Telephone number of the contact person
기간: 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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Relationship between the patient and the contact person
기간: 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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Date of birth
기간: Baseline
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as date |
Baseline
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Date of death
기간: 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 |
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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Living arrangements
기간: 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) |
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
기간: 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 |
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)
기간: 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) |
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
기간: 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) |
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)
기간: 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 |
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
기간: 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 |
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
기간: 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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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
기간: 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 |
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)
기간: 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: 0-33, 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
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Hypertension
기간: 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 |
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
기간: 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 |
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
기간: 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 |
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
기간: 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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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
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Medical Outcomes Study Social Support Survey (MOS-SSS)
기간: 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: 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
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Short Form 36 Health Survey (SF-36)
기간: 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 |
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
기간: 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) |
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)
기간: 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) |
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)
기간: 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) |
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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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 249_15 Bc
- DRKS00040516 (레지스트리 식별자: German Clinical Trials Register)
- ZMV I 1-2520KEU305 (기타 보조금/기금 번호: German Federal Ministry of Health (BMG))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .