Insights From the Retina on Cerebral Microvascular Dysfunction in Haemorrhagic Stroke

NCT ID: NCT04363619

Last Updated: 2022-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-23

Study Completion Date

2022-07-28

Brief Summary

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Fundoscopy, optical coherence tomography (OCT) and OCT-angiography (OCTA) are established examinations and bear minimal risks. The recognition of retinal microvascular signs will enhance the pathophysiological understanding of the vasculopathy in patients with intracerebral haemorrhage (ICH) and aneurysmatic subarachnoid hemorrhage (aSAH) and might serve as prognostic and diagnostic indicators.

Detailed Description

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The purpose of the study is to

* To evaluate the feasibility of fundoscopy, OCT and OCTA imaging in the environment of a Neurocritical Care Unit (NCCU)
* To detect, quantify and associate microvascular changes in the retina with signs of micro-vessel disease in ICH and DCI in aSAH

Conditions

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Intracerebral Hemorrhage

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Controls

Group Type PLACEBO_COMPARATOR

OCT and OCTA

Intervention Type DIAGNOSTIC_TEST

Fundoscopy, OCT and OCTA will be performed 4 times in patients

ICH

Group Type EXPERIMENTAL

OCT and OCTA

Intervention Type DIAGNOSTIC_TEST

Fundoscopy, OCT and OCTA will be performed 4 times in patients

aSAH

Group Type EXPERIMENTAL

OCT and OCTA

Intervention Type DIAGNOSTIC_TEST

Fundoscopy, OCT and OCTA will be performed 4 times in patients

Interventions

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OCT and OCTA

Fundoscopy, OCT and OCTA will be performed 4 times in patients

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* All groups

* Primary ICH or aSAH with symptoms onset \< 3 days
* 18 to unlimited years of age
* Signed informed consent obtained from legal representative or patient ICH group
* Primary ICH localized either in basal ganglia, thalamus, pons or cerebellum aSAH group
* Ruptured aneurysm visualized in contrast-enhanced computed tomography (angio-CT), MRI or cerebral angiography Control group
* Stroke due to perimesencepahlic subarachnoid hemorrhage, arteriovenous malformation or isolated traumatic brain injury

Exclusion Criteria

* All groups

* Cerebral amyloid angiopathy or other neurodegenerative disease
* History of migraine with aura or ischemic stroke
* Contraindication for pupil dilation (intracranial hypertension, allergy against mydriatics, angle closure glaucoma)
* Any pre-existing or manifest ocular condition affecting either the integrity of retinal vessels, transparency of optical media or the risk of acute angle closure glaucoma
* Concomitant instable critical illness (e.g. sepsis, multi-organ failure)
* Intracranial pressure \> 20mmHg and refractory to cerebrospinal fluid drainage
* Pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Emanuela Keller

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2020-01524

Identifier Type: -

Identifier Source: org_study_id

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