Cerebral StrokeEVACORMANCT04447599
Conjunctival and Retinal Vascularization and Small Vessel Disease
A study testing photography of conjunctival vessels in people with Cerebral Stroke, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The purpose of the study is to use a simple photography of conjunctival vessels to search for an association between conjunctival vessels abnormalities and the load of small vessel disease as quantified by MRI in patients with TIA s and minor strokes. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Cerebral Stroke
- What is being tested?
- photography of conjunctival vessels
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 850 participants
- Where
- 1 siteFrance
- Study dates
- 20 Oct 2020to 20 Oct 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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients treated for a minor stroke or transient ischemic attack justifying an MRI.
Who cannot join
- Severe eye dryness with conjunctiva hyperhemia,
- Taking eye treatments for glaucoma
- Inflammatory or infectious eye damage resulting in conjunctiva hyperhemia: conjunctivitis, herpetic keratitis, ulcer, abscess, uveitis, peripheral ulcerative keratitis, interstitial keratitis, scleritis, episcleritis, pingueculitis, scarring eye pemphigoide, acute seizure by closing of the angle,
- History of eye surgery. Among eye surgeries, those that can modify the conjunctiva are strabismus surgeries, glaucoma, conjunctiva resection surgery (pterygial or tumor) or wound surgery or finally recent cataract surgery (2 years).
- Persons under the legal protection of adults (safeguarding justice, guardianship, curatorship, institutionalized, or under mandate of future protection)
- Administrative problems: inability to give about informed information, no coverage by a social security plan, refusal to sign a consent.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
NASR Nathalie
Toulouse
NASR Nathalie, 5 61 77 56 02 ext. +33, nasr.n@chu-toulouse.fr
About this study
Official title: Study of Conjunctival and Retinal Blood Vessels for the Evaluation of the Load of Small Vessel Disease in Patients With Transient Ischemic Attacks (TIAs) and Minor Strokes
The purpose of the study is to use a simple photography of conjunctival vessels to search for an association between conjunctival vessels abnormalities and the load of small vessel disease as quantified by MRI in patients with TIA s and minor strokes.
The artificial intelligence (AI) tools will permit to classify abnormalities of conjunctival vessels that predict the load of small vessel disease in TIAs and strokes.
Read the detailed description
Small vessel disease is a risk factor of ischemic or hemorrhagic stroke and a direct cause of lacunar and hemorrhagic infarcts. Moreover, it is associated of cognitive impairment, like psychomotor retardation, deficits of attention, planning, and set-shifting, and dysexecutive syndrome.
This disease affects the cerebral vessels of small diameters. Magnetic Resonance Imaging (MRI) is the gold standard for the diagnosis and the screening of this pathology. However it is an imaging with limit access and high cost.
Vessels of bulbar conjunctiva have a small caliber like the small cerebral vessels and have the same origin: carotid arteries. They are easy to study with photography. The analysis of these vessels may be a new way of screening the small vessel disease, easier to use than MRI.
Retinal vascularization is also easier to study with photography of fundus without dilatation by retinograph. Several studies already demonstrated an association between retinal abnormalities and load of small vessel disease. However, no relation was established between these modification and impairment of conjunctival vascularization in this cerebral pathology although those have the same arterial origin and vascular diameters.
The strategy is to take a picture of temporal bulbar conjunctiva and fundus for patients with symptoms of TIA and minor stroke with all etiologies. Patients will be classified according to Fazekas staging and presence of lacunar infarcts. First, photography of bulbar conjunctiva will be analyzed by an artificial intelligence in " deep learning " to demonstrate a correlation between abnormalities of conjunctival vessels and staging of small cerebral disease. After that, photography of fundus will be analyzed with the same AI to search a correlation between conjunctival and retinal vascularization in small vessel disease.
The present study will include patients with symptoms of TIAs and minor strokes coming at clinic of TIA in University Hospital Toulouse. A consultation by a neurologist will be done, than MRI will be prescribed for each of them. After a therapeutic care, they will go to the ophthalmologist for a photo of their bulbar conjunctival of each eye and photography of fundus without dilatation. The follow up will be realized the same day.
- Conditions
- Cerebral Stroke
- Being tested
- photography of conjunctival vessels
- Keywords
- small vessel disease, STRIVE recommendations, artificial intelligence in " deep learning ", bulbar conjunctiva photography, MRI, screening, fundus
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photography of conjunctival vesselsOther
patient will have photo of their bulbar conjunctival of each eye and photography of fundus without dilatation
| Study group | Role | What they receive |
|---|---|---|
| Photographs | Experimental | Photographs Receives: Other: photography of conjunctival vessels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of conjunctival vascular abnormalities
Association between numbers of conjunctival vascular abnormalities and the load of small cerebral disease highlighted by neural network in " deep learning ". This outcome is collected after the end of the inclusion of all patients.
Measured: day 1
Secondary outcomes (3)
Classification of different types of vascular abnormalities in different grades of small vessel disease
Classification of different types of vascular abnormalities found in different grades of small vessel disease using the same neural network and also their association with cerebral macroangiopathy
Measured: Day 1
Absence of difference between the 2 eyes
Research for the absence of difference of abnormalities between both eyes
Measured: Day 1
same stade of vascular abnormalities
Association between abnormalities detected in fundus with retinograph and conjunctival vessels morphology in assessment of load of small vessel disease.Same sensitivity and specificity as conjunctiva photographs for each stage of vascular abnormalities
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start20 Oct 2020
- Primary completion20 Oct 2022 (estimated)
- Study completion20 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie NASR, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04447599
- Sponsor's protocol ID
- RC31/20/0001
- Acronym
- EVACORMA
- Status last verified
- Aug 2021
- First submitted
- 8 May 2020
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Conjunctival and Retinal Blood Vessels for the Evaluation of the Load of Small Vessel Disease in Patients With Transient Ischemic Attacks (TIAs) and Minor Strokes
- ClinicalTrials.gov ID
- NCT04447599
- Acronym / sponsor ID
- EVACORMA / RC31/20/0001
- Conditions
- Cerebral Stroke
- Keywords
- small vessel disease, STRIVE recommendations, artificial intelligence in " deep learning ", bulbar conjunctiva photography, MRI, screening, fundus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 20 Oct 2022 (estimated)
- Study completion
- 20 Oct 2022 (estimated)
- First posted
- 25 Jun 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.
The purpose of the study is to use a simple photography of conjunctival vessels to search for an association between conjunctival vessels abnormalities and the load of small vessel disease as quantified by MRI in patients with TIA s and minor strokes.
The artificial intelligence (AI) tools will permit to classify abnormalities of conjunctival vessels that predict the load of small vessel disease in TIAs and strokes.
Detailed description
Small vessel disease is a risk factor of ischemic or hemorrhagic stroke and a direct cause of lacunar and hemorrhagic infarcts. Moreover, it is associated of cognitive impairment, like psychomotor retardation, deficits of attention, planning, and set-shifting, and dysexecutive syndrome.
This disease affects the cerebral vessels of small diameters. Magnetic Resonance Imaging (MRI) is the gold standard for the diagnosis and the screening of this pathology. However it is an imaging with limit access and high cost.
Vessels of bulbar conjunctiva have a small caliber like the small cerebral vessels and have the same origin: carotid arteries. They are easy to study with photography. The analysis of these vessels may be a new way of screening the small vessel disease, easier to use than MRI.
Retinal vascularization is also easier to study with photography of fundus without dilatation by retinograph. Several studies already demonstrated an association between retinal abnormalities and load of small vessel disease. However, no relation was established between these modification and impairment of conjunctival vascularization in this cerebral pathology although those have the same arterial origin and vascular diameters.
The strategy is to take a picture of temporal bulbar conjunctiva and fundus for patients with symptoms of TIA and minor stroke with all etiologies. Patients will be classified according to Fazekas staging and presence of lacunar infarcts. First, photography of bulbar conjunctiva will be analyzed by an artificial intelligence in " deep learning " to demonstrate a correlation between abnormalities of conjunctival vessels and staging of small cerebral disease. After that, photography of fundus will be analyzed with the same AI to search a correlation between conjunctival and retinal vascularization in small vessel disease.
The present study will include patients with symptoms of TIAs and minor strokes coming at clinic of TIA in University Hospital Toulouse. A consultation by a neurologist will be done, than MRI will be prescribed for each of them. After a therapeutic care, they will go to the ophthalmologist for a photo of their bulbar conjunctival of each eye and photography of fundus without dilatation. The follow up will be realized the same day.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Photographs | Experimental | Other: photography of conjunctival vesselsPhotographs |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients treated for a minor stroke or transient ischemic attack justifying an MRI.
Key exclusion criteria (6 listed)
- Severe eye dryness with conjunctiva hyperhemia,
- Taking eye treatments for glaucoma
- Inflammatory or infectious eye damage resulting in conjunctiva hyperhemia: conjunctivitis, herpetic keratitis, ulcer, abscess, uveitis, peripheral ulcerative keratitis, interstitial keratitis, scleritis, episcleritis, pingueculitis, scarring eye pemphigoide, acute seizure by closing of the angle,
- History of eye surgery. Among eye surgeries, those that can modify the conjunctiva are strabismus surgeries, glaucoma, conjunctiva resection surgery (pterygial or tumor) or wound surgery or finally recent cataract surgery (2 years).
- Persons under the legal protection of adults (safeguarding justice, guardianship, curatorship, institutionalized, or under mandate of future protection)
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 |
|---|---|---|
| photography of conjunctival vesselspatient will have photo of their bulbar conjunctival of each eye and photography of fundus without dilatation | Other | Photographs |
Primary outcome
Numbers of conjunctival vascular abnormalities
Time frame: day 1
Association between numbers of conjunctival vascular abnormalities and the load of small cerebral disease highlighted by neural network in " deep learning ". This outcome is collected after the end of the inclusion of all patients.
3 secondary outcomes
Classification of different types of vascular abnormalities in different grades of small vessel disease
Time frame: Day 1
Absence of difference between the 2 eyes
Time frame: Day 1
same stade of vascular abnormalities
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
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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.
Nathalie NASR, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing photography of conjunctival vessels in people with Cerebral Stroke, run by University Hospital, Toulouse at 1 site in France.
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 1 inclusion and 6 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 31 Aug 2021. 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 France. 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. 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 Nathalie NASR, MD (05 61 77 56 02 ext. 33, nasr.n@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers of conjunctival vascular abnormalities (time frame: day 1). 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 31 Aug 2021.