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

Sponsor

University of Zurich (Other)

Overall Status

Completed

CT.gov ID

NCT04363619

Collaborator

(none)

Enrollment

Location

Arms

17.1

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intracerebral Hemorrhage	Diagnostic Test: OCT and OCTA	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Feb 23, 2021

Actual Primary Completion Date :

Jul 28, 2022

Actual Study Completion Date :

Jul 28, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Zurich	Zurich		Switzerland	CH-8091

Sponsors and Collaborators

University of Zurich

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Emanuela Keller, Prof. Dr., University of Zurich

ClinicalTrials.gov Identifier:

NCT04363619

Other Study ID Numbers:

2020-01524

First Posted:

Apr 27, 2020

Last Update Posted:

Aug 4, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Cerebral Hemorrhage

Hemorrhagic Stroke

Hemorrhage

Study Results

No Results Posted as of Aug 4, 2022