Conjunctival and Retinal Vascularization and Small Vessel Disease (EVACORMA)
Primary Purpose
Cerebral Stroke
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
photography of conjunctival vessels
Sponsored by
About this trial
This is an interventional diagnostic trial for Cerebral Stroke focused on measuring small vessel disease, STRIVE recommendations, artificial intelligence in " deep learning ", bulbar conjunctiva photography, MRI, screening, fundus
Eligibility Criteria
Inclusion Criteria:
- Patients treated for a minor stroke or transient ischemic attack justifying an MRI.
Exclusion Criteria:
- 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.
Sites / Locations
- NASR NathalieRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Photographs
Arm Description
Photographs
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Absence of difference between the 2 eyes
Research for the absence of difference of abnormalities between both eyes
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
Full Information
NCT ID
NCT04447599
First Posted
May 8, 2020
Last Updated
August 30, 2021
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT04447599
Brief Title
Conjunctival and Retinal Vascularization and Small Vessel Disease
Acronym
EVACORMA
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 20, 2020 (Actual)
Primary Completion Date
October 20, 2022 (Anticipated)
Study Completion Date
October 20, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Stroke
Keywords
small vessel disease, STRIVE recommendations, artificial intelligence in " deep learning ", bulbar conjunctiva photography, MRI, screening, fundus
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
850 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Photographs
Arm Type
Experimental
Arm Description
Photographs
Intervention Type
Other
Intervention Name(s)
photography of conjunctival vessels
Intervention Description
patient will have photo of their bulbar conjunctival of each eye and photography of fundus without dilatation
Primary Outcome Measure Information:
Title
Numbers of conjunctival vascular abnormalities
Description
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.
Time Frame
day 1
Secondary Outcome Measure Information:
Title
Classification of different types of vascular abnormalities in different grades of small vessel disease
Description
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
Time Frame
Day 1
Title
Absence of difference between the 2 eyes
Description
Research for the absence of difference of abnormalities between both eyes
Time Frame
Day 1
Title
same stade of vascular abnormalities
Description
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
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients treated for a minor stroke or transient ischemic attack justifying an MRI.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nathalie NASR, MD
Phone
05 61 77 56 02
Ext
33
Email
nasr.n@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie NASR, MD
Organizational Affiliation
Toulouse University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
NASR Nathalie
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
NASR Nathalie
Phone
5 61 77 56 02
Ext
+33
Email
nasr.n@chu-toulouse.fr
12. IPD Sharing Statement
Learn more about this trial
Conjunctival and Retinal Vascularization and Small Vessel Disease
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