Retinal Vessel Analysis (rGA) at the Patient Bed in the Context of Non-traumatic Subarachnoid Haemorrhage

NCT ID: NCT04094155

Last Updated: 2019-09-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-01
• Study Completion Date: 2021-01-01

Brief Summary

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.

Conditions

Non-traumatic Subarachnoid Haemorrhage

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Retinal fundoscopy

Retinal vascular analysis by retinal fundoscopy over a 3 week period in stationary patients after aneurysmatic subarachnoid hemorrhage

Group Type: EXPERIMENTAL

retinal vascular analysis

Intervention Type: DIAGNOSTIC_TEST

Retinal fundoscopy over a 3 week period in stationary patients after aneurysmatic subarachnoid hemorrhage

Interventions

retinal vascular analysis

Retinal fundoscopy over a 3 week period in stationary patients after aneurysmatic subarachnoid hemorrhage

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RWTH Aachen University

OTHER

Sponsor Role: lead

Responsible Party

Gerrit Alexander Schubert

Head of Vascular Neurosurgery and Neurovascular Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gerrit A Schubert, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Locations

Uniklinik RWTH Aachen, Klinik für Neurochirurgie

Aachen, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Gerrit A Schubert, Prof. Dr.

Role: CONTACT

gschubert@ukaachen.de

+492418088480

Facility Contacts

Gerrit A Schubert, Prof. Dr.

Role: primary

gschubert@ukaachen.de

+49 2418088480

References

Albanna W, Conzen C, Weiss M, Seyfried K, Kotliar K, Schmidt TP, Kuerten D, Hescheler J, Bruecken A, Schmidt-Trucksass A, Neumaier F, Wiesmann M, Clusmann H, Schubert GA. Non-invasive Assessment of Neurovascular Coupling After Aneurysmal Subarachnoid Hemorrhage: A Prospective Observational Trial Using Retinal Vessel Analysis. Front Neurol. 2021 Jun 14;12:690183. doi: 10.3389/fneur.2021.690183. eCollection 2021.

Reference Type: DERIVED

PMID: 34194387 (View on PubMed)

Other Identifiers

14-061

Identifier Type: -

Identifier Source: org_study_id