Insights From the Retina on Cerebral Microvascular Dysfunction in Haemorrhagic Stroke (RETINA-ICH)

August 3, 2022 updated by: Emanuela Keller, University of Zurich

Insights From the Retina on Cerebral Microvascular Dysfunction in Haemorrhagic Stroke. A Prospective Observational Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, CH-8091
        • University Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Controls
Diagnostic test: OCT and OCTA
Fundoscopy, OCT and OCTA will be performed 4 times in patients
Experimental: ICH
Diagnostic test: OCT and OCTA
Fundoscopy, OCT and OCTA will be performed 4 times in patients
Experimental: aSAH
Diagnostic test: OCT and OCTA
Fundoscopy, OCT and OCTA will be performed 4 times in patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
i. Number of fundus photography, OCT, and OCTA examinations with usable and quantifiable results.
Time Frame: From hospital entry up to 3-6 months
From hospital entry up to 3-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2021

Primary Completion (Actual)

July 28, 2022

Study Completion (Actual)

July 28, 2022

Study Registration Dates

First Submitted

April 23, 2020

First Submitted That Met QC Criteria

April 23, 2020

First Posted (Actual)

April 27, 2020

Study Record Updates

Last Update Posted (Actual)

August 4, 2022

Last Update Submitted That Met QC Criteria

August 3, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-01524

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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