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Clinical Trials/NCT04363619
NCT04363619
Completed
Not Applicable

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

University of Zurich1 site in 1 country14 target enrollmentFebruary 23, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intracerebral Hemorrhage
Sponsor
University of Zurich
Enrollment
14
Locations
1
Primary Endpoint
i. Number of fundus photography, OCT, and OCTA examinations with usable and quantifiable results.
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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

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

Registry
clinicaltrials.gov
Start Date
February 23, 2021
End Date
July 28, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Emanuela Keller

Prof. Dr.

University of Zurich

Eligibility Criteria

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

Outcomes

Primary Outcomes

i. Number of fundus photography, OCT, and OCTA examinations with usable and quantifiable results.

Time Frame: From hospital entry up to 3-6 months

Study Sites (1)

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