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.
調査の概要
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Gerrit A Schubert, Prof. Dr.
- 電話番号：+492418088480
- メール：gschubert@ukaachen.de
研究場所
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Aachen、ドイツ、52074
- 募集
- Uniklinik RWTH Aachen, Klinik für Neurochirurgie
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コンタクト：
- Gerrit A Schubert, Prof. Dr.
- 電話番号：+49 2418088480
- メール：gschubert@ukaachen.de
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Clinical Progression of Delayed cortical ischemia
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Occurrence of delayed ischemic neurological deficit (DIND)
時間枠：21 days
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21 days
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Angiographic vasospasm
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
捜査官
- 主任研究者：Gerrit A Schubert, Prof. Dr.、Principal Investigator
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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