Insights From the Retina on Cerebral Microvascular Dysfunction in Haemorrhagic Stroke (NCT04363619) | Clinical Trial Compass
CompletedNot Applicable
Insights From the Retina on Cerebral Microvascular Dysfunction in Haemorrhagic Stroke
Switzerland14 participantsStarted 2021-02-23
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
i. Number of fundus photography, OCT, and OCTA examinations with usable and quantifiable results.