Insights From the Retina on Cerebral Microvascular Dysfunction in Haemorrhagic Stroke

NCT04363619 | Completed

• 1 other identifier: 2020-01524
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracerebral Hemorrhage

Outcome Measures

Primary Outcomes (1)

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

  From hospital entry up to 3-6 months

Study Arms (3)

Controls

PLACEBO COMPARATOR

Diagnostic Test: OCT and OCTA

ICH

EXPERIMENTAL

Diagnostic Test: OCT and OCTA

aSAH

EXPERIMENTAL

Diagnostic Test: OCT and OCTA

Interventions

OCT and OCTA DIAGNOSTIC_TEST

Fundoscopy, OCT and OCTA will be performed 4 times in patients

Controls; ICH; aSAH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All groups
• Primary ICH or aSAH with symptoms onset \< 3 days
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, CH-8091, Switzerland

Location

MeSH Terms

Conditions

Cerebral Hemorrhage

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 27, 2020
• Study Start: February 23, 2021
• Primary Completion: July 28, 2022
• Study Completion: July 28, 2022
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)