Retinal Vessel Analysis (rGA) at the Patient Bed in the Context of Non-traumatic Subarachnoid Haemorrhage
A subarachnoid hemorrhage occurs in about 10 out of 100,000 people each year. This bleeding leads to irritation and constriction of blood vessels in the brain (vasospasm) in two out of three people affected within four to 21 days and thus to reduced blood flow. This can lead to a stroke and serious damage. In order to be able to diagnose and treat a constriction of the blood vessels at an early stage, there are various examination methods which, however, have various disadvantages such as radiation exposure of the patient, low sensitivity or high effort. Therefore, the prediction and timely therapy of vascular constrictions is currently only successful in a few cases before the reduced blood flow has already led to irreversible damage.
The aim of this study is to investigate whether the so-called retinal vascular analysis can be used in addition to previous standard examinations for the early detection of diseases of the cerebral blood circulation. This method has few side effects and has been successfully used for 50 years to examine the blood circulation in the eye.
연구 개요
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Gerrit A Schubert, Prof. Dr.
- 전화번호: +492418088480
- 이메일: gschubert@ukaachen.de
연구 장소
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Aachen, 독일, 52074
- 모병
- Uniklinik RWTH Aachen, Klinik für Neurochirurgie
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연락하다:
- Gerrit A Schubert, Prof. Dr.
- 전화번호: +49 2418088480
- 이메일: gschubert@ukaachen.de
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Female or male patient, age ≥ 18 years
- Inpatient stay in the clinic
- Written informed consent for participation in the study prior to beginning of treatment
- Written consent for further evaluation of the images and for the scientific publication of the study results
- Non-traumatic subarachnoid haemorrhage confirmed by computer tomography or magnetic resonance tomography or cerebrospinal fluid puncture (collection of nerve water from the lower part of the lumbar spine
Exclusion Criteria:
- Female or male patient < 18 years
- Pregnancy, Lactation
- Lack of written consent to participate in the study and to further evaluate the image material collected
- Known allergy to MS eye drops (active substance: phenylephrine/tropicamide
- Narrow chamber angle, narrow angle glaucoma, Terson syndrome (if it makes retinal vascular imaging impossible
- Persons in a dependency or employment relationship with the investigator
- Persons who are accommodated in a facility by judicial or administrative order
- Receipt and intake of a study drug within the last 30 days
- Supine position in bed
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Retinal fundoscopy
Retinal vascular analysis by retinal fundoscopy over a 3 week period in stationary patients after aneurysmatic subarachnoid hemorrhage
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Retinal fundoscopy over a 3 week period in stationary patients after aneurysmatic subarachnoid hemorrhage
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Clinical Progression of Delayed cortical ischemia
기간: 21 days
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Delayed cortical ischemia as ischemia in cranial computer tomography or cranial magnetic resonance tomography that occurred later than 24 hours after admission to hospital
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21 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Occurrence of delayed ischemic neurological deficit (DIND)
기간: 21 days
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21 days
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Angiographic vasospasm
기간: 7 days
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Occurence of an angiographic vasospasm measured by:
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7 days
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Metabolic deficiency supply
기간: 21 days
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Measured as change in lactate-pyruvate ratio in microdialysis
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21 days
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Metabolic deficiency supply
기간: 21 days
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Measured as change in reduction in parenchymal oxygen partial pressure measurement
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21 days
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Relative underperfusion
기간: 21 days
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Measured by Perfusion-Computer-Tomography
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21 days
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Objective degree of recovery
기간: 3 Month
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Measured by Glasgow-Outcome-Scale; Scale by which patients who have experienced brain damage can be divided into 5 groups that allow to describe the degree of recovery in a standardized and objective manner (1: death; 2: vegetative condition, the patient is unresponsive.
The higher cognitive functions are extinguished; 3: severe disability, the patient is conscious, but cannot cope with normal everyday activities without help; 4: moderate disability, the patient can live largely independently, but is not able to pursue a normal working life; 5: light to no handicap, the neurological, physical, and psychological deficits are so low that the patient can participate normally in social and economic activities)
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3 Month
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공동 작업자 및 조사자
수사관
- 수석 연구원: Gerrit A Schubert, Prof. Dr., Principal Investigator
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
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 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. .
retinal vascular analysis에 대한 임상 시험
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Nano RetinaMedPass International종료됨
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Hvidovre University HospitalElsassFonden종료됨
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Spaarne GasthuisLeiden University Medical Center모집하지 않고 적극적으로
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Belfast Health and Social Care TrustBristol Royal Infirmary; Royal Infirmary of Edinburgh; Golden Jubilee National Hospital알려지지 않은