Back to resultsInsights From the Retina on Cerebral Microvascular Dysfunction in Haemorrhagic Stroke (RETINA-ICH)
Primary Purpose
Intracerebral Hemorrhage
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
OCT and OCTA
Sponsored by
About this trial
This is an interventional diagnostic trial for Intracerebral Hemorrhage
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
Sites / Locations
- University Hospital Zurich
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Controls
ICH
aSAH
Arm Description
Outcomes
Primary Outcome Measures
i. Number of fundus photography, OCT, and OCTA examinations with usable and quantifiable results.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04363619
Brief Title
Insights From the Retina on Cerebral Microvascular Dysfunction in Haemorrhagic Stroke
Acronym
RETINA-ICH
Official Title
Insights From the Retina on Cerebral Microvascular Dysfunction in Haemorrhagic Stroke. A Prospective Observational Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
February 23, 2021 (Actual)
Primary Completion Date
July 28, 2022 (Actual)
Study Completion Date
July 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Zurich
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracerebral Hemorrhage
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Controls
Arm Type
Placebo Comparator
Arm Title
ICH
Arm Type
Experimental
Arm Title
aSAH
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
OCT and OCTA
Intervention Description
Fundoscopy, OCT and OCTA will be performed 4 times in patients
Primary Outcome Measure Information:
Title
i. Number of fundus photography, OCT, and OCTA examinations with usable and quantifiable results.
Time Frame
From hospital entry up to 3-6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University Hospital Zurich
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Insights From the Retina on Cerebral Microvascular Dysfunction in Haemorrhagic Stroke
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