Intracerebral HemorrhageRETINA-ICHNCT04363619
Insights From the Retina on Cerebral Microvascular Dysfunction in Haemorrhagic Stroke
A study testing OCT and OCTA in people with Intracerebral Hemorrhage, run by University of Zurich at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- OCT and OCTA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteSwitzerland
- Study dates
- 23 Feb 2021to 28 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Insights From the Retina on Cerebral Microvascular Dysfunction in Haemorrhagic Stroke. A Prospective Observational Study
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.
Read the 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
- Conditions
- Intracerebral Hemorrhage
- Being tested
- OCT and OCTA
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT and OCTADiagnostic test
Fundoscopy, OCT and OCTA will be performed 4 times in patients
| Study group | Role | What they receive |
|---|---|---|
| Controls | Placebo comparator | Not described Receives: Diagnostic Test: OCT and OCTA |
| ICH | Experimental | Not described Receives: Diagnostic Test: OCT and OCTA |
| aSAH | Experimental | Not described Receives: Diagnostic Test: OCT and OCTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
i. Number of fundus photography, OCT, and OCTA examinations with usable and quantifiable results.
Measured: From hospital entry up to 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start23 Feb 2021
- Primary completion28 Jul 2022
- Study completion28 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emanuela Keller, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363619
- Sponsor's protocol ID
- 2020-01524
- Acronym
- RETINA-ICH
- Status last verified
- Aug 2022
- First submitted
- 23 Apr 2020
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insights From the Retina on Cerebral Microvascular Dysfunction in Haemorrhagic Stroke. A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04363619
- Acronym / sponsor ID
- RETINA-ICH / 2020-01524
- Conditions
- Intracerebral Hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 28 Jul 2022 (actual)
- Study completion
- 28 Jul 2022 (actual)
- First posted
- 27 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Controls | Placebo comparator | Diagnostic Test: OCT and OCTA |
| ICH | Experimental | Diagnostic Test: OCT and OCTA |
| aSAH | Experimental | Diagnostic Test: OCT and OCTA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- All groups
Key exclusion criteria (8 listed)
- All groups
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCT and OCTAFundoscopy, OCT and OCTA will be performed 4 times in patients | Diagnostic test | Controls, ICH, aSAH |
Primary outcome
i. Number of fundus photography, OCT, and OCTA examinations with usable and quantifiable results.
Time frame: From hospital entry up to 3-6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCT and OCTA in people with Intracerebral Hemorrhage, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
i. Number of fundus photography, OCT, and OCTA examinations with usable and quantifiable results. (time frame: From hospital entry up to 3-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.