Insights From the Retina on Cerebral Microvascular Dysfunction in Haemorrhagic Stroke

Intracerebral Hemorrhage Clinical Trial

— RETINA-ICH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04363619
• Other study ID #: 2020-01524
• Status: Completed
• Phase: N/A
• Start date: February 23, 2021
• Est. completion date: July 28, 2022

Study information

• Verified date: August 2022
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: July 28, 2022
• Est. primary completion date: July 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Hemorrhagic Stroke
• Intracerebral Hemorrhage

Intervention

Diagnostic Test:
• OCT and OCTA
Fundoscopy, OCT and OCTA will be performed 4 times in patients

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	i. Number of fundus photography, OCT, and OCTA examinations with usable and quantifiable results.		From hospital entry up to 3-6 months