Insights From the Retina on Cerebral Microvascular Dysfunction in Haemorrhagic Stroke

Not Applicable

Completed

• Conditions: Intracerebral Hemorrhage
• Interventions: Diagnostic Test: OCT and OCTA

• Registration Number: NCT04363619
• Lead Sponsor: University of Zurich

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

Study Timeline

• Study First Submitted: 2020-04-23
• Study First Submitted QC: 2020-04-23
• Study First Posted: 2020-04-27
• Study Start: 2021-02-23
• Primary Completion: 2022-07-28
• Study Completion: 2022-07-28
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-03
• Last Update Posted: 2022-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ICH	OCT and OCTA	-
aSAH	OCT and OCTA	-
Controls	OCT and OCTA	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Zurich; 🇨🇭 Zurich, Switzerland