Cerebral Small Vessel Disease and OCT AngioNCT05052788
OCT Angio in Cerebral Small Vessel Disease
An observational study of Cerebral Small Vessel Disease and OCT Angio, run by Ain Shams University.
Trial summary
The aim of the study is to: - detect changes in retinal structure and microvasculature in patients with cerebral small vessel disease using optical coherence tomography angiography , correlate these changes with brain imaging markers and determine if ( OCTA ) can be used as a screening tool for cerebral small vessel… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cerebral Small Vessel Disease and OCT Angio
- What is being tested?
- Optical coherence tomography angiography
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2021to 1 Jan 2022
- Phase
- Observational
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Two groups of people, patients (case group) and (control group), both groups are frequency matched in age and sex.
Who may be able to join
- Patients diagnosed clinically with small vessel disease and verified by MRI.
- must be at age of 50 or more.
Who cannot join
- large vessel disease or non-ischemic leukoencephalopathy.
- Patients with any type of cerebral haemorrhage .
- Diabetic patients .
- concurrent retinal diseases as epiretinal memberane and macular degeneration.
- Past history of retinal operation or ocular surgery except for cataract surgery.
- An history of glaucoma or optic neuropathy.
- hematological diseases and coagulopathies.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Optical Coherence Tomography Angiography in Patients With Cerebral Small Vessel Disease.
The aim of the study is to: - detect changes in retinal structure and microvasculature in patients with cerebral small vessel disease using optical coherence tomography angiography , correlate these changes with brain imaging markers and determine if ( OCTA ) can be used as a screening tool for cerebral small vessel disease.
Read the detailed description
Cerebral small vessel disease ( CSVD ) refers to all pathological changes affecting the small vasculature of the brain including; small perforating arterioles,capillaries and venules.
Vascular risk factors that are commonly found in large vessel disease have shown to contribute to CSVD, as well, including hypertension, diabetes mellitus, smoking and dyslipidemia.Also old age is considered to be a risk factor as the prevelance of CSVD increases with age affecting nearly 5 % of people aged 50 years and almost 100% in those older than 90 years .
Cerebral amyloid angiopathy is one of the suggested underlying pathologies in some cases of CSVD.
Clinically, CSVD accounts for 25% of ischemic strokes and 50% of dementias . It may present as acute events (focal neurological deficit ) known as lacunar syndrome or chronic events as mild cognitive dysfunction, dementia, mood disorders, gait disturbance, sleep disorder and urinary incontinence. Also, it may be a symptomatic.
Although CSVD is a common reason for strokes and vascular dementia, pathogenesis is still poorly understood . It is suggested that the endothelial dysfunction in cerebral microvessels may be a key problem. Endothelial failure leads to increased permeability and increased leakage into the vessel wall and the surrounding tissue , damaging of the vessel wall , inflammation, demyelination, glial scar formation , thickening and stiffness of vessels leading to failure of autoregulation, narrowing of the lumen and occlusion , causing featured focal ischemic lesions in the brain parenchyma.
Neuroimaging markers seen on MRI are classified into: Recent small subcortical infarct (DWI), Lacune of presumed vascular origin (FLAIR), White matter hyperintensity of presumed vascular origin (FLAIR), Perivascular space (T1 , T2), cerebral microbleed (T2*-weighted GRE/SWI).
The changes in brain microvasculature are difficult to be visualized in vivo . Because of similarities between brain and retina in anatomy , embryology and physiology , investigating the retinal vessels network may reflect the brain condition.
Optical coherence tomography angiography ( OCTA ) is a novel, real-time and noninvasive technique to detect retinal and choroidal blood flow in vivo.
The retinal capillary network is arranged anatomically into several layers as following ; 3 macular plexuses, 4 plexuses in peripapillary region and one capillary layer in midequatorial and anterior zones where the retina is thinner. OCTA devices are based on (en face) approach to get information of the superficial and deep plexuses. 4 en face zones are detected ; superfacial plexus in ganglion cell layer, deep plexus, photoreceptors(outer retina) and choroiocapillaries. For each en face zone , the indices of perfusion could be reached.
OCTA has a big advantage over classic methods as retinal microvasculature are segmented into layers and can be visualized and quantified more accurately . It is a safe and rapid technique giving a vascular map of retinal blood flow without using intravenous dye.
- Being tested
- Optical coherence tomography angiography
- Medical subject headings
- Cerebral Small Vessel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherence tomography angiographyDevice
Also called MRI
OCT-A detects the motion of blood using intrinsic signals to capture the location of blood vessels. Despite its insensitivity to leakage and the relatively small field of view, the development of OCT-A has the potential to improve our knowledge of the physiology and pathophysiology of the eye.
MRI as a stroke protocol, including T1 and T2 weighted images, diffusion weighted images (DWI), fluid attenuated inversion recovery (FLAIR), magnetic resonance angiography (MRA), and gradient recalled echo (GRE) T2* weighted images, using a machine 1.5 tesla General Electric machine .
| Study group | Role | What they receive |
|---|---|---|
| Case group | 40 patients according to inclusion criteria . Receives: Device: Optical coherence tomography angiography | |
| Control group | 20 normal people with no history of previous brain insult and with free neurological examination . Receives: Device: Optical coherence tomography angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of retinal microvasculature changes using OCT angio (OCTA).
OCTA can detect five parameters:
( macular vessel density, macular thickness, ganglion cell layer thickness, pericapillary nerve fiber layer thickness and pericapillary vessel density ).
Compare between case and control group using OCTA parameters then correlate OCTA parameters with clinical and neurological imaging parameters.
Measured: Anticipated 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start1 Oct 2021 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebral Small Vessel Disease and OCT AngioStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052788
- Sponsor's protocol ID
- 930107130
- Status last verified
- Sep 2021
- First submitted
- 13 Sep 2021
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cannistraro RJ, Badi M, Eidelman BH, Dickson DW, Middlebrooks EH, Meschia JF. CNS small vessel disease: A clinical review. Neurology. 2019 Jun 11;92(24):1146-1156. doi: 10.1212/WNL.0000000000007654. Epub 2019 May 29.
PubMed 31142635Chen X, Wang J, Shan Y, Cai W, Liu S, Hu M, Liao S, Huang X, Zhang B, Wang Y, Lu Z. Cerebral small vessel disease: neuroimaging markers and clinical implication. J Neurol. 2019 Oct;266(10):2347-2362. doi: 10.1007/s00415-018-9077-3. Epub 2018 Oct 5.
PubMed 30291424
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography Angiography in Patients With Cerebral Small Vessel Disease.
- ClinicalTrials.gov ID
- NCT05052788
- Acronym / sponsor ID
- 930107130
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 22 Sep 2021 (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.
The aim of the study is to: - detect changes in retinal structure and microvasculature in patients with cerebral small vessel disease using optical coherence tomography angiography , correlate these changes with brain imaging markers and determine if ( OCTA ) can be used as a screening tool for cerebral small vessel disease.
Detailed description
Cerebral small vessel disease ( CSVD ) refers to all pathological changes affecting the small vasculature of the brain including; small perforating arterioles,capillaries and venules.
Vascular risk factors that are commonly found in large vessel disease have shown to contribute to CSVD, as well, including hypertension, diabetes mellitus, smoking and dyslipidemia.Also old age is considered to be a risk factor as the prevelance of CSVD increases with age affecting nearly 5 % of people aged 50 years and almost 100% in those older than 90 years .
Cerebral amyloid angiopathy is one of the suggested underlying pathologies in some cases of CSVD.
Clinically, CSVD accounts for 25% of ischemic strokes and 50% of dementias . It may present as acute events (focal neurological deficit ) known as lacunar syndrome or chronic events as mild cognitive dysfunction, dementia, mood disorders, gait disturbance, sleep disorder and urinary incontinence. Also, it may be a symptomatic.
Although CSVD is a common reason for strokes and vascular dementia, pathogenesis is still poorly understood . It is suggested that the endothelial dysfunction in cerebral microvessels may be a key problem. Endothelial failure leads to increased permeability and increased leakage into the vessel wall and the surrounding tissue , damaging of the vessel wall , inflammation, demyelination, glial scar formation , thickening and stiffness of vessels leading to failure of autoregulation, narrowing of the lumen and occlusion , causing featured focal ischemic lesions in the brain parenchyma.
Neuroimaging markers seen on MRI are classified into: Recent small subcortical infarct (DWI), Lacune of presumed vascular origin (FLAIR), White matter hyperintensity of presumed vascular origin (FLAIR), Perivascular space (T1 , T2), cerebral microbleed (T2*-weighted GRE/SWI).
The changes in brain microvasculature are difficult to be visualized in vivo . Because of similarities between brain and retina in anatomy , embryology and physiology , investigating the retinal vessels network may reflect the brain condition.
Optical coherence tomography angiography ( OCTA ) is a novel, real-time and noninvasive technique to detect retinal and choroidal blood flow in vivo.
The retinal capillary network is arranged anatomically into several layers as following ; 3 macular plexuses, 4 plexuses in peripapillary region and one capillary layer in midequatorial and anterior zones where the retina is thinner. OCTA devices are based on (en face) approach to get information of the superficial and deep plexuses. 4 en face zones are detected ; superfacial plexus in ganglion cell layer, deep plexus, photoreceptors(outer retina) and choroiocapillaries. For each en face zone , the indices of perfusion could be reached.
OCTA has a big advantage over classic methods as retinal microvasculature are segmented into layers and can be visualized and quantified more accurately . It is a safe and rapid technique giving a vascular map of retinal blood flow without using intravenous dye.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | – | Device: Optical coherence tomography angiography40 patients according to inclusion criteria . |
| Control group | – | Device: Optical coherence tomography angiography20 normal people with no history of previous brain insult and with free neurological examination . |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Two groups of people, patients (case group) and (control group), both groups are frequency matched in age and sex.
Key inclusion criteria (2 listed)
- Patients diagnosed clinically with small vessel disease and verified by MRI.
- must be at age of 50 or more.
Key exclusion criteria (7 listed)
- large vessel disease or non-ischemic leukoencephalopathy.
- Patients with any type of cerebral haemorrhage .
- Diabetic patients .
- concurrent retinal diseases as epiretinal memberane and macular degeneration.
- Past history of retinal operation or ocular surgery except for cataract surgery.
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 |
|---|---|---|
| Optical coherence tomography angiographyAlso: MRIOCT-A detects the motion of blood using intrinsic signals to capture the location of blood vessels. Despite its insensitivity to leakage and the relatively small field of view, the development of OCT-A has the potential to improve our knowledge of the physiology and pathophysiology of the eye. MRI as a stroke protocol, including T1 and T2 weighted images, diffusion weighted images (DWI), fluid attenuated inversion recovery (FLAIR), magnetic resonance angiography (MRA), and gradient recalled echo (GRE) T2* weighted images, using a machine 1.5 tesla General Electric machine . | Device | Case group, Control group |
Primary outcome
Detection of retinal microvasculature changes using OCT angio (OCTA).
Time frame: Anticipated 2 months
OCTA can detect five parameters: ( macular vessel density, macular thickness, ganglion cell layer thickness, pericapillary nerve fiber layer thickness and pericapillary vessel density ). Compare between case and control group using OCTA parameters then correlate OCTA parameters with clinical and neurological imaging parameters.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Background: PubMed 31142635Cannistraro RJ, Badi M, Eidelman BH, Dickson DW, Middlebrooks EH, Meschia JF. CNS small vessel disease: A clinical review. Neurology. 2019 Jun 11;92(24):1146-1156. doi: 10.1212/WNL.0000000000007654. Epub 2019 May 29.
- Background: PubMed 30291424Chen X, Wang J, Shan Y, Cai W, Liu S, Hu M, Liao S, Huang X, Zhang B, Wang Y, Lu Z. Cerebral small vessel disease: neuroimaging markers and clinical implication. J Neurol. 2019 Oct;266(10):2347-2362. doi: 10.1007/s00415-018-9077-3. Epub 2018 Oct 5.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Small Vessel Disease and OCT Angio, run by Ain Shams University.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Mohammad Gaber Mahmoud (01122240327, Drsaramohammad33@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of retinal microvasculature changes using OCT angio (OCTA). (time frame: Anticipated 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05052788, which also lists 2 linked publications.
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 29 Sep 2021.