<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04447599</url>
  </required_header>
  <id_info>
    <org_study_id>RC31/20/0001</org_study_id>
    <nct_id>NCT04447599</nct_id>
  </id_info>
  <brief_title>Conjunctival and Retinal Vascularization and Small Vessel Disease</brief_title>
  <acronym>EVACORMA</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Toulouse</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to use a simple photography of conjunctival vessels to search for&#xD;
      an association between conjunctival vessels abnormalities and the load of small vessel&#xD;
      disease as quantified by MRI in patients with TIA s and minor strokes.&#xD;
&#xD;
      The artificial intelligence (AI) tools will permit to classify abnormalities of conjunctival&#xD;
      vessels that predict the load of small vessel disease in TIAs and strokes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Small vessel disease is a risk factor of ischemic or hemorrhagic stroke and a direct cause of&#xD;
      lacunar and hemorrhagic infarcts. Moreover, it is associated of cognitive impairment, like&#xD;
      psychomotor retardation, deficits of attention, planning, and set-shifting, and dysexecutive&#xD;
      syndrome.&#xD;
&#xD;
      This disease affects the cerebral vessels of small diameters. Magnetic Resonance Imaging&#xD;
      (MRI) is the gold standard for the diagnosis and the screening of this pathology. However it&#xD;
      is an imaging with limit access and high cost.&#xD;
&#xD;
      Vessels of bulbar conjunctiva have a small caliber like the small cerebral vessels and have&#xD;
      the same origin: carotid arteries. They are easy to study with photography. The analysis of&#xD;
      these vessels may be a new way of screening the small vessel disease, easier to use than MRI.&#xD;
&#xD;
      Retinal vascularization is also easier to study with photography of fundus without dilatation&#xD;
      by retinograph. Several studies already demonstrated an association between retinal&#xD;
      abnormalities and load of small vessel disease. However, no relation was established between&#xD;
      these modification and impairment of conjunctival vascularization in this cerebral pathology&#xD;
      although those have the same arterial origin and vascular diameters.&#xD;
&#xD;
      The strategy is to take a picture of temporal bulbar conjunctiva and fundus for patients with&#xD;
      symptoms of TIA and minor stroke with all etiologies. Patients will be classified according&#xD;
      to Fazekas staging and presence of lacunar infarcts. First, photography of bulbar conjunctiva&#xD;
      will be analyzed by an artificial intelligence in &quot; deep learning &quot; to demonstrate a&#xD;
      correlation between abnormalities of conjunctival vessels and staging of small cerebral&#xD;
      disease. After that, photography of fundus will be analyzed with the same AI to search a&#xD;
      correlation between conjunctival and retinal vascularization in small vessel disease.&#xD;
&#xD;
      The present study will include patients with symptoms of TIAs and minor strokes coming at&#xD;
      clinic of TIA in University Hospital Toulouse. A consultation by a neurologist will be done,&#xD;
      than MRI will be prescribed for each of them. After a therapeutic care, they will go to the&#xD;
      ophthalmologist for a photo of their bulbar conjunctival of each eye and photography of&#xD;
      fundus without dilatation. The follow up will be realized the same day.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 20, 2020</start_date>
  <completion_date type="Anticipated">October 20, 2022</completion_date>
  <primary_completion_date type="Anticipated">October 20, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Numbers of conjunctival vascular abnormalities</measure>
    <time_frame>day 1</time_frame>
    <description>Association between numbers of conjunctival vascular abnormalities and the load of small cerebral disease highlighted by neural network in &quot; deep learning &quot;. This outcome is collected after the end of the inclusion of all patients.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Classification of different types of vascular abnormalities in different grades of small vessel disease</measure>
    <time_frame>Day 1</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absence of difference between the 2 eyes</measure>
    <time_frame>Day 1</time_frame>
    <description>Research for the absence of difference of abnormalities between both eyes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>same stade of vascular abnormalities</measure>
    <time_frame>Day 1</time_frame>
    <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</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">850</enrollment>
  <condition>Cerebral Stroke</condition>
  <arm_group>
    <arm_group_label>Photographs</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Photographs</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>photography of conjunctival vessels</intervention_name>
    <description>patient will have photo of their bulbar conjunctival of each eye and photography of fundus without dilatation</description>
    <arm_group_label>Photographs</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients treated for a minor stroke or transient ischemic attack justifying an MRI.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe eye dryness with conjunctiva hyperhemia,&#xD;
&#xD;
          -  Taking eye treatments for glaucoma&#xD;
&#xD;
          -  Inflammatory or infectious eye damage resulting in conjunctiva hyperhemia:&#xD;
             conjunctivitis, herpetic keratitis, ulcer, abscess, uveitis, peripheral ulcerative&#xD;
             keratitis, interstitial keratitis, scleritis, episcleritis, pingueculitis, scarring&#xD;
             eye pemphigoide, acute seizure by closing of the angle,&#xD;
&#xD;
          -  History of eye surgery. Among eye surgeries, those that can modify the conjunctiva are&#xD;
             strabismus surgeries, glaucoma, conjunctiva resection surgery (pterygial or tumor) or&#xD;
             wound surgery or finally recent cataract surgery (2 years).&#xD;
&#xD;
          -  Persons under the legal protection of adults (safeguarding justice, guardianship,&#xD;
             curatorship, institutionalized, or under mandate of future protection)&#xD;
&#xD;
          -  Administrative problems: inability to give about informed information, no coverage by&#xD;
             a social security plan, refusal to sign a consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nathalie NASR, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Toulouse University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nathalie NASR, MD</last_name>
    <phone>05 61 77 56 02</phone>
    <phone_ext>33</phone_ext>
    <email>nasr.n@chu-toulouse.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>NASR Nathalie</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>NASR Nathalie</last_name>
      <phone>5 61 77 56 02</phone>
      <phone_ext>+33</phone_ext>
      <email>nasr.n@chu-toulouse.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>May 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>August 30, 2021</last_update_submitted>
  <last_update_submitted_qc>August 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>small vessel disease</keyword>
  <keyword>STRIVE recommendations</keyword>
  <keyword>artificial intelligence in &quot; deep learning &quot;</keyword>
  <keyword>bulbar conjunctiva photography</keyword>
  <keyword>MRI</keyword>
  <keyword>screening</keyword>
  <keyword>fundus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04447599
org study id: RC31/20/0001
nct id: NCT04447599
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Numbers of conjunctival vascular abnormalities
time frame: day 1
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.
measure: Classification of different types of vascular abnormalities in different grades of small vessel disease
time frame: Day 1
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
measure: Absence of difference between the 2 eyes
time frame: Day 1
description: Research for the absence of difference of abnormalities between both eyes
measure: same stade of vascular abnormalities
time frame: Day 1
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
arm group label: Photographs
arm group type: Experimental
description: Photographs
intervention type: Other
intervention name: photography of conjunctival vessels
description: patient will have photo of their bulbar conjunctival of each eye and photography of fundus without dilatation
arm group label: Photographs
criteria: 
gender: All
minimum age: 55 Years
maximum age: 80 Years
healthy volunteers: No
last name: Nathalie NASR, MD
role: Principal Investigator
affiliation: Toulouse University Hospital
last name: Nathalie NASR, MD
phone: 05 61 77 56 02
phone ext: 33
email: nasr.n@chu-toulouse.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Stroke