xml: <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/NCT06004154</url>
    </required_header>
    <id_info>
      <org_study_id>GCL_2023_3</org_study_id>
      <nct_id>NCT06004154</nct_id>
    </id_info>
    <brief_title>Post-therapeutic Imaging Evaluation of Patients With Horton's Disease (Giant Cell Arteritis) (EvHortim)</brief_title>
    <acronym>EvHortim</acronym>
    <official_title>Post-therapeutic Imaging Evaluation of Patients With Horton's Disease (Giant Cell Arteritis)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fondation Ophtalmologique Adolphe de Rothschild</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fondation Ophtalmologique Adolphe de Rothschild</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Giant cell arteritis (GCA), also known as Horton's disease, is an inflammatory arteritis of&#xD;
        the large and medium-sized arteries, with an estimated incidence of 17.8/100,000 in people&#xD;
        over 50.&#xD;
  &#xD;
        The disease presents potential ophthalmological, neurological, cardiac and aortic vascular&#xD;
        complications, making diagnosis an emergency in cases of suspected Horton's disease.&#xD;
  &#xD;
        only corticosteroid therapy started as early as possible can prevent these complications.&#xD;
  &#xD;
        Diagnosis has historically relied on temporal artery biopsy, but the recent ACR/EULAR 2022&#xD;
        classification criteria propose alternatives to this invasive examination, in particular&#xD;
        imaging tests such as temporal artery ultrasound and PET scans. Although not included in&#xD;
        these latest recommendations, high-definition wall MRI can also provide arguments in favor of&#xD;
        this diagnosis, and avoid the need for a temporal artery biopsy, the sensitivity of which is&#xD;
        only 75%. The investigators recently demonstrated in a prospective cohort that wall MRI,&#xD;
        possibly coupled with temporal artery ultrasound or retinal angiography, was far superior to&#xD;
        temporal artery biopsy in diagnostic performance.&#xD;
  &#xD;
        The main limitation of these imaging tests is the lack of data in the literature on the&#xD;
        evolution of abnormalities over time, and in particular after initiation of oral&#xD;
        corticosteroid therapy. This uncertainty makes it difficult to use these examinations to&#xD;
        monitor disease activity, particularly in cases of suspected relapse, a frequent situation in&#xD;
        which the clinician is regularly put at fault due to an often frustrating symptomatology and&#xD;
        the possible absence of a frank biological inflammatory syndrome.&#xD;
  &#xD;
        The investigators propose to conduct a study aimed at describing the evolution of cranial&#xD;
        vessel wall abnormalities on wall MRI and ultrasound by systematically repeating these&#xD;
        examinations at 1 month, 3 months from the initial MRI performed at diagnosis, in addition to&#xD;
        the follow-up performed as part of care at 6 and 12 months from diagnosis. In the event of a&#xD;
        relapse in the intervening period, a new MRI scan can be performed and compared with the most&#xD;
        recent MRI scan, to look for evidence of disease activity.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">April 2027</completion_date>
    <primary_completion_date type="Anticipated">April 2027</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Describe the evolution over time of angiographic-MRI abnormalities at 1 month, 3 months, 6 and 12 months from the diagnosis of Horton's disease.</measure>
      <time_frame>Day0 to Month12</time_frame>
      <description>thickening (yes/no)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Describe the evolution over time of ultrasound abnormalities at 1 month, 3 months, 6 and 12 months from the diagnosis of Horton's disease.</measure>
      <time_frame>Day0 to Month12</time_frame>
      <description>contrast enhancement (yes/no)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Describe the evolution over time of ultrasound abnormalities at 1 month, 3 months, 6 and 12 months from the diagnosis of Horton's disease.</measure>
      <time_frame>Day0 to Month12</time_frame>
      <description>halo measurement (in mm)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Describe the evolution over time of ultrasound abnormalities at 1 month, 3 months, 6 and 12 months from the diagnosis of Horton's disease.</measure>
      <time_frame>Day0 to Month12</time_frame>
      <description>intima-media thickness measurement (in mm)</description>
    </primary_outcome>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Giant Cell Arteritis</condition>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Injected cerebral MRI angiography and ultrasound of the superior aortic trunks, temporal and axillary arteries</intervention_name>
      <description>Injected cerebral MRI angiography and ultrasound of the superior aortic trunks, temporal and axillary arteries added to the usual follow-up at 1, 3, 6 and 12 months</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients treated at the Fondation A de Rothschild Hospital for Horton's disease.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient aged 50 and over&#xD;
  &#xD;
            -  Having received informed consent to participate in the study&#xD;
  &#xD;
            -  Affiliated or beneficiary of a social insurance scheme&#xD;
  &#xD;
            -  Patients with giant cell arteritis according to ACR/EULAR 2022 criteria&#xD;
  &#xD;
            -  Diagnosed with MRI and ultrasound.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Absolute or relative contraindication to MRI (incompatible implantable device,&#xD;
               claustrophobia, etc.)&#xD;
  &#xD;
            -  Hypersensitivity to gadobutrol&#xD;
  &#xD;
            -  Patient under legal protection&#xD;
  &#xD;
            -  Pregnant or breast-feeding women&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Polymyalgia Rheumatica</mesh_term>
      <mesh_term>Giant Cell Arteritis</mesh_term>
      <mesh_term>Arteritis</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06004154
  org study id: GCL_2023_3
  nct id: NCT06004154
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Giant cell arteritis (GCA), also known as Horton's disease, is an inflammatory arteritis of
        the large and medium-sized arteries, with an estimated incidence of 17.8/100,000 in people
        over 50.
  
        The disease presents potential ophthalmological, neurological, cardiac and aortic vascular
        complications, making diagnosis an emergency in cases of suspected Horton's disease.
  
        only corticosteroid therapy started as early as possible can prevent these complications.
  
        Diagnosis has historically relied on temporal artery biopsy, but the recent ACR/EULAR 2022
        classification criteria propose alternatives to this invasive examination, in particular
        imaging tests such as temporal artery ultrasound and PET scans. Although not included in
        these latest recommendations, high-definition wall MRI can also provide arguments in favor of
        this diagnosis, and avoid the need for a temporal artery biopsy, the sensitivity of which is
        only 75%. The investigators recently demonstrated in a prospective cohort that wall MRI,
        possibly coupled with temporal artery ultrasound or retinal angiography, was far superior to
        temporal artery biopsy in diagnostic performance.
  
        The main limitation of these imaging tests is the lack of data in the literature on the
        evolution of abnormalities over time, and in particular after initiation of oral
        corticosteroid therapy. This uncertainty makes it difficult to use these examinations to
        monitor disease activity, particularly in cases of suspected relapse, a frequent situation in
        which the clinician is regularly put at fault due to an often frustrating symptomatology and
        the possible absence of a frank biological inflammatory syndrome.
  
        The investigators propose to conduct a study aimed at describing the evolution of cranial
        vessel wall abnormalities on wall MRI and ultrasound by systematically repeating these
        examinations at 1 month, 3 months from the initial MRI performed at diagnosis, in addition to
        the follow-up performed as part of care at 6 and 12 months from diagnosis. In the event of a
        relapse in the intervening period, a new MRI scan can be performed and compared with the most
        recent MRI scan, to look for evidence of disease activity.
  observational model: Cohort
  time perspective: Prospective
  measure: Describe the evolution over time of angiographic-MRI abnormalities at 1 month, 3 months, 6 and 12 months from the diagnosis of Horton's disease.
  time frame: Day0 to Month12
  description: thickening (yes/no)
  measure: Describe the evolution over time of ultrasound abnormalities at 1 month, 3 months, 6 and 12 months from the diagnosis of Horton's disease.
  time frame: Day0 to Month12
  description: contrast enhancement (yes/no)
  measure: Describe the evolution over time of ultrasound abnormalities at 1 month, 3 months, 6 and 12 months from the diagnosis of Horton's disease.
  time frame: Day0 to Month12
  description: halo measurement (in mm)
  measure: Describe the evolution over time of ultrasound abnormalities at 1 month, 3 months, 6 and 12 months from the diagnosis of Horton's disease.
  time frame: Day0 to Month12
  description: intima-media thickness measurement (in mm)
  intervention type: Diagnostic Test
  intervention name: Injected cerebral MRI angiography and ultrasound of the superior aortic trunks, temporal and axillary arteries
  description: Injected cerebral MRI angiography and ultrasound of the superior aortic trunks, temporal and axillary arteries added to the usual follow-up at 1, 3, 6 and 12 months
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Polymyalgia Rheumatica
  mesh term: Giant Cell Arteritis
  mesh term: Arteritis