<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/NCT03765424</url>
  </required_header>
  <id_info>
    <org_study_id>ULvsPET GCA cohort</org_study_id>
    <nct_id>NCT03765424</nct_id>
  </id_info>
  <brief_title>Evaluation of Ultrasound and PET/CT in the Diagnosis and Monitoring of Giant Cell Arteritis</brief_title>
  <official_title>Evaluation of Ultrasound and PET/CT in the Diagnosis and Monitoring of Giant Cell Arteritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Danish Rheumatism Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hartmann Fonden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>AP Moeller Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Aase and Ejnar Danielsens Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Aarhus</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 aim of this project is to prospectively evaluate the diagnostic accuracy of different&#xD;
      imaging tools in specific giant cell arteritis disease subsets before and after treatment&#xD;
      initiation. Diagnostic tools with high sensitivity and specificity are a prerequisite for&#xD;
      optimal treatment of GCA patients.&#xD;
&#xD;
      Specifically, the diagnostic accuracy of ultrasound (US) as compared to 18F-FDG PET/CT in&#xD;
      new-onset, treatment naïve large vessel(LV)-GCA patients is investigated. Furthermore,&#xD;
      long-term follow up including US, 18F-FDG PET/CT and cross sectional imaging is performed to&#xD;
      explore the potential of imaging as monitoring and prognostic tools.&#xD;
&#xD;
      In this observational cohort, the diagnostic accuracy of 18F-FDG PET/CT after three and ten&#xD;
      days of glucocorticoid treatment in the subset of LV-GCA patients and the diagnostic accuracy&#xD;
      of 18F-FDG PET/CT in cranial artery inflammation in new-onset, treatment naïve c-GCA patients&#xD;
      as compared to a control group of patients with a previous diagnosis of malignant melanoma&#xD;
      was also evaluated and is registered elsewhere (ClinicalTrials.gov Identifier: NCT03285945&#xD;
      and NCT03409913, respectively)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The diagnosis of GCA is clinical and syndrome-based. Only few years ago, temporal artery&#xD;
      biopsy (TAB) was the standard diagnostic tool to confirm diagnosis, although sensitivity is&#xD;
      moderate[3,4] and its outcome seldom affects treatment management[5]. Today, the European&#xD;
      League Against Rheumatism (EULAR) recommends diagnostic imaging in all patients suspected of&#xD;
      GCA[6]. The imaging of choice is based on the suspected vessel involvement. In patients&#xD;
      suspected of cranial GCA (c-GCA), vascular ultrasound (US) is the recommended first line&#xD;
      imaging test, whereas Fluorine-18-fluorodeoxyglucose (18F-FDG) positron emissions&#xD;
      tomography/computed tomography (PET/CT) is not recommended for the assessment of cranial&#xD;
      arteries.&#xD;
&#xD;
      In patients suspected of large vessel involvement (LV-GCA), 18F-FDG PET/CT, US, magnetic&#xD;
      resonance imaging (MRI) or CT can be used to confirm disease, but no specific priority of the&#xD;
      imaging tests is given. US is an attractive first line imaging in LV-GCA suspected patients&#xD;
      since it is increasingly used in the diagnosis of c-GCA, is readily available and cheap.&#xD;
      18F-FDG PET/CT is an appealing diagnostic tool in LV-GCA suspected patients, since it also&#xD;
      evaluates malignancy and infection, differential diagnoses often considered in this disease&#xD;
      subset. However, 18F-FDG PET/CT is often not readily available, is expensive and exposes&#xD;
      patients to radiation. Moreover, its sensitivity seems to decrease with glucocorticoid (GC)&#xD;
      treatment and the window of opportunity in which sensitivity is unaffected is unknown.&#xD;
&#xD;
      Relapse during glucocorticoid tapering is frequent in GCA. However, the evaluation of&#xD;
      potential GCA disease activity relies on unspecific symptoms and inflammatory biomarkers.&#xD;
      There is a significant overlap between symptoms of GCA disease activity and GC adverse effect&#xD;
      and the same holds for symptoms and biomarkers of disease activity and infection, making the&#xD;
      evaluation difficult. Accurate tools to support treatment decisions, avoid over-treatment&#xD;
      without risk of GCA related complications are lacking.&#xD;
&#xD;
      The aim of this project is to prospectively evaluate the diagnostic accuracy of different&#xD;
      imaging tools in specific giant cell arteritis disease subsets before and after treatment&#xD;
      initiation. Diagnostic tools with high sensitivity and specificity are a prerequisite for&#xD;
      optimal treatment of GCA patients.&#xD;
&#xD;
      Specifically, the diagnostic accuracy of ultrasound (US) as compared to 18F-FDG PET/CT in&#xD;
      new-onset, treatment naïve large vessel(LV)-GCA patients is investigated. Furthermore,&#xD;
      long-term follow up including US, 18F-FDG PET/CT and cross sectional imaging is performed to&#xD;
      explore the potential of imaging as monitoring and prognostic tools.&#xD;
&#xD;
      In this observational cohort, the diagnostic accuracy of 18F-FDG PET/CT after three and ten&#xD;
      days of glucocorticoid treatment in the subset of LV-GCA patients and the diagnostic accuracy&#xD;
      of 18F-FDG PET/CT in cranial artery inflammation in new-onset, treatment naïve c-GCA patients&#xD;
      as compared to a control group of patients with a previous diagnosis of malignant melanoma&#xD;
      was also evaluated and is registered elsewhere (ClinicalTrials.gov Identifier: NCT03285945&#xD;
      and NCT03409913, respectively)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2014</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">July 1, 2018</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>Diagnostic accuracy of large vessel ultrasound with PET/CT as reference</measure>
    <time_frame>Time of diagnosis/pre-treatment</time_frame>
    <description>Large vessel ultrasound for LV-GCA diagnosis is considered positive in the presence of a halo in carotid and/or axillary arteries.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Large vessel intima-media thickness (IMT) cut off for LV-GCA diagnosis with PET/CT as reference</measure>
    <time_frame>Time of diagnosis/pre-treatment</time_frame>
    <description>IMT measurement performed on the distal vessel wall in carotid and axillary arteries</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic accuracy vascular ultrasound (overall)</measure>
    <time_frame>Time of diagnosis/pre-treatment</time_frame>
    <description>Vascular ultrasound for GCA diagnosis is considered positive in the presence of a halo in temporal, carotid and/or axillary arteries.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic accuracy of vascular ultrasound after treatment (day 3, 10 and week 8)</measure>
    <time_frame>3 days, 10 days and 8 weeks after initiated treatment</time_frame>
    <description>Vascular ultrasound for GCA diagnosis is considered positive in the presence of a halo in temporal, carotid and/or axillary arteries.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic accuracy of PET/CT of cranial arteries for c-GCA diagnosis (reference: American College of Rheumatology 1990 criteria)</measure>
    <time_frame>Time of diagnosis/pre-treatment</time_frame>
    <description>cranial artery (vertebral, maxillary and temporal) FDG uptake above surrounding tissue FDG uptake is considered consistent with vasculitis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Temporal artery biopsy</measure>
    <time_frame>Time of diagnosis</time_frame>
    <description>Temporal artery biopsy considered positive in the presence of an inflammatory infiltrate in any vessel wall layer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Halo sign for monitoring disease activity (week 8, 24 and 15 months)</measure>
    <time_frame>week 8, 24 and 15 months after initiated treatment</time_frame>
    <description>Presence or absence of halos on US</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composite halo score for monitoring disease activity (week 8, 24 and 15 months)</measure>
    <time_frame>week 8, 24 and 15 months after initiated treatment</time_frame>
    <description>Composite halo score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intima media thickness for monitoring disease activity (week 8, 24 and 15 months)</measure>
    <time_frame>week 8, 24 and 15 months after initiated treatment</time_frame>
    <description>Maximum intima media thickness (IMT) measurement on US</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PETVAS for monitoring disease activity (15 months)</measure>
    <time_frame>15 months after treatment is initiated</time_frame>
    <description>Composite PET scores (e.g.PETVAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Semiquantitative FDG measure for monitoring disease activity (15 months)</measure>
    <time_frame>15 months after treatment is initiated</time_frame>
    <description>Maximum semiquantitative FDG measures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FDG burden for monitoring disease activity (15 months)</measure>
    <time_frame>15 months after treatment is initiated</time_frame>
    <description>Composite scores of FDG inflammatory burden (summarising FDG uptake in voxels of interest)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PETVAS for GCA prognosis (baseline)</measure>
    <time_frame>4-5 years after diagnosis</time_frame>
    <description>PETVAS score (summarising graded (1-4) FDG uptake in arterial vessel segments)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Semiquantitative FDG measure for GCA prognosis (baseline)</measure>
    <time_frame>4-5 years after diagnosis</time_frame>
    <description>Maximum semiquantitative FDG measures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FDG burden for GCA prognosis (baseline)</measure>
    <time_frame>4-5 years after diagnosis</time_frame>
    <description>Composite scores of arterial FDG uptake (summarising FDG uptake in voxels of interest)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aortic diameter 4-5 years after diagnosis</measure>
    <time_frame>4-5 years after diagnosis</time_frame>
    <description>Aortic diameter on cross sectional imaging</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vessel wall thickening 4-5 years after diagnosis</measure>
    <time_frame>4-5 years after diagnosis</time_frame>
    <description>Vessel wall thickening</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Patient global NRS</measure>
    <time_frame>Baseline, day 10, week 8, 24 and 15 months</time_frame>
    <description>Patients global experience of disease activity on a numerical range scale (0-10)</description>
  </other_outcome>
  <other_outcome>
    <measure>Physician NRS</measure>
    <time_frame>Baseline, day 10, week 8, 24 and 15 months</time_frame>
    <description>Physicians global judgement of disease activity on a numerical range scale (0-10)</description>
  </other_outcome>
  <other_outcome>
    <measure>CRP</measure>
    <time_frame>Baseline, day 3 and 10, week 8, 24 and 15 months</time_frame>
    <description>c-reactive protein (mg/l)</description>
  </other_outcome>
  <other_outcome>
    <measure>Physicians judgement of disease activity</measure>
    <time_frame>Baseline, day 10, week 8, 24 and 15 months</time_frame>
    <description>Overall judgement of disease activity (remission, possible activity not requiring treatment, activity/relapse)</description>
  </other_outcome>
  <other_outcome>
    <measure>Cumulated glucocorticoid dose</measure>
    <time_frame>Baseline, day 10, week 8, 24 and 15 months</time_frame>
    <description>Cumulated glucocorticoid dose (mg)</description>
  </other_outcome>
  <other_outcome>
    <measure>Glucocorticoid dose</measure>
    <time_frame>Baseline, day 10, week 8, 24 and 15 months</time_frame>
    <description>Glucocorticoid dose (mg)</description>
  </other_outcome>
  <other_outcome>
    <measure>Cardiovascular events</measure>
    <time_frame>4-5 years</time_frame>
    <description>Cardiovascular events (number)</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">101</enrollment>
  <condition>Giant Cell Arteritis</condition>
  <condition>Vasculitis</condition>
  <arm_group>
    <arm_group_label>GCA cases</arm_group_label>
    <description>GCA cases were patients with a clinical diagnosis of GCA based on a rheumatologists evaluation of history taking, physical examination, laboratory screening and initial PET report (reporting potential large vessel inflammation but not considering cranial artery inflammation).&#xD;
GCA was considered large vessel (LV) and/or cranial (c) GCA cases:&#xD;
LV-GCA cases were patients with a clinical diagnosis of GCA and verified LV inflammation by 18F-FDG PET/CT with or without concomitant c-GCA.&#xD;
C-GCA cases, for the exploratory analysis of the performance of US and PET in c-GCA, were patients with a clinical diagnosis of GCA fulfilling the 1990 American College of Rheumatology (ACR) criteria, with or without concomitant LV-GCA.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>controls</arm_group_label>
    <description>Controls were GCA suspected patients in whom GCA diagnosis was dismissed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Ultrasound</intervention_name>
    <description>Ultraosund of temporal, carotid and axillary arteries</description>
    <arm_group_label>GCA cases</arm_group_label>
    <arm_group_label>controls</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Full blood EDTA plasma Lithium-heparin plasma serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        For the GCA suspect cohort, patients referred to Department of Rheumatology, Aarhus&#xD;
        University Hospital due to suspicion of GCA are considered for inclusion. Patients in whom&#xD;
        a 18F-FDG PET/CT is not performed by the time of referral and who presents with unequivocal&#xD;
        cranial symptoms of GCA requiring acute initiation of GC treatment are not considered for&#xD;
        inclusion.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age more than 50 years&#xD;
&#xD;
          2. C-reactive protein (CRP)&gt;15 mg/L or erythrocyte sedimentation rate (ESR)&gt;40 mm/h&#xD;
&#xD;
          3. Either&#xD;
&#xD;
               1. cranial symptoms such as new-onset headache or scalp tenderness, jaw or tongue&#xD;
                  claudication, visual disturbances&#xD;
&#xD;
               2. new-onset limb claudication&#xD;
&#xD;
               3. protracted constitutional symptoms, defined as weight loss&gt;5 kilograms or&#xD;
                  fever&gt;38 degrees Celcius for &gt;3 weeks&#xD;
&#xD;
               4. Bilateral shoulder pain and morning stiffness.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. oral glucocorticoid treatment within the past month;&#xD;
&#xD;
          2. subcutaneous, intramuscular, intra-articular or intravenous glucocorticoid within the&#xD;
             past 2 months;&#xD;
&#xD;
          3. DMARD treatment or other immunosuppressive therapy within the past 3 months;&#xD;
&#xD;
          4. ongoing treatment with interleukin2;&#xD;
&#xD;
          5. previous diagnosis of GCA or polymyalgia rheumatica;&#xD;
&#xD;
          6. any disease potentially causing large vessel inflammation, that is autoimmune&#xD;
             diseases; rheumatoid arthritis, Cogans syndrome, relapsing polychondritis, ankylosing&#xD;
             spondylitis, systemic lupus erythematosus, Buerger's disease, Bechet's disease,&#xD;
             inflammatory bowel disease, infections; syphilis, known active current or history of&#xD;
             recurrent tuberculosis, hepatitis or HIV, or other large vessel disease; sarcoidosis,&#xD;
             neurofibromatosis, congenital coarctation, Marfans syndrome, Ehlers-Danlos syndrome,&#xD;
             retroperitoneal fibrosis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Berit Nielsen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Rheumatology</affiliation>
  </overall_official>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>October 1, 2021</last_update_submitted>
  <last_update_submitted_qc>October 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2021</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>Vasculitis</mesh_term>
    <mesh_term>Arteritis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03765424
org study id: ULvsPET GCA cohort
nct id: NCT03765424
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this project is to prospectively evaluate the diagnostic accuracy of different
      imaging tools in specific giant cell arteritis disease subsets before and after treatment
      initiation. Diagnostic tools with high sensitivity and specificity are a prerequisite for
      optimal treatment of GCA patients.

      Specifically, the diagnostic accuracy of ultrasound (US) as compared to 18F-FDG PET/CT in
      new-onset, treatment naïve large vessel(LV)-GCA patients is investigated. Furthermore,
      long-term follow up including US, 18F-FDG PET/CT and cross sectional imaging is performed to
      explore the potential of imaging as monitoring and prognostic tools.

      In this observational cohort, the diagnostic accuracy of 18F-FDG PET/CT after three and ten
      days of glucocorticoid treatment in the subset of LV-GCA patients and the diagnostic accuracy
      of 18F-FDG PET/CT in cranial artery inflammation in new-onset, treatment naïve c-GCA patients
      as compared to a control group of patients with a previous diagnosis of malignant melanoma
      was also evaluated and is registered elsewhere (ClinicalTrials.gov Identifier: NCT03285945
      and NCT03409913, respectively)
The diagnosis of GCA is clinical and syndrome-based. Only few years ago, temporal artery
      biopsy (TAB) was the standard diagnostic tool to confirm diagnosis, although sensitivity is
      moderate[3,4] and its outcome seldom affects treatment management[5]. Today, the European
      League Against Rheumatism (EULAR) recommends diagnostic imaging in all patients suspected of
      GCA[6]. The imaging of choice is based on the suspected vessel involvement. In patients
      suspected of cranial GCA (c-GCA), vascular ultrasound (US) is the recommended first line
      imaging test, whereas Fluorine-18-fluorodeoxyglucose (18F-FDG) positron emissions
      tomography/computed tomography (PET/CT) is not recommended for the assessment of cranial
      arteries.

      In patients suspected of large vessel involvement (LV-GCA), 18F-FDG PET/CT, US, magnetic
      resonance imaging (MRI) or CT can be used to confirm disease, but no specific priority of the
      imaging tests is given. US is an attractive first line imaging in LV-GCA suspected patients
      since it is increasingly used in the diagnosis of c-GCA, is readily available and cheap.
      18F-FDG PET/CT is an appealing diagnostic tool in LV-GCA suspected patients, since it also
      evaluates malignancy and infection, differential diagnoses often considered in this disease
      subset. However, 18F-FDG PET/CT is often not readily available, is expensive and exposes
      patients to radiation. Moreover, its sensitivity seems to decrease with glucocorticoid (GC)
      treatment and the window of opportunity in which sensitivity is unaffected is unknown.

      Relapse during glucocorticoid tapering is frequent in GCA. However, the evaluation of
      potential GCA disease activity relies on unspecific symptoms and inflammatory biomarkers.
      There is a significant overlap between symptoms of GCA disease activity and GC adverse effect
      and the same holds for symptoms and biomarkers of disease activity and infection, making the
      evaluation difficult. Accurate tools to support treatment decisions, avoid over-treatment
      without risk of GCA related complications are lacking.

      The aim of this project is to prospectively evaluate the diagnostic accuracy of different
      imaging tools in specific giant cell arteritis disease subsets before and after treatment
      initiation. Diagnostic tools with high sensitivity and specificity are a prerequisite for
      optimal treatment of GCA patients.

      Specifically, the diagnostic accuracy of ultrasound (US) as compared to 18F-FDG PET/CT in
      new-onset, treatment naïve large vessel(LV)-GCA patients is investigated. Furthermore,
      long-term follow up including US, 18F-FDG PET/CT and cross sectional imaging is performed to
      explore the potential of imaging as monitoring and prognostic tools.

      In this observational cohort, the diagnostic accuracy of 18F-FDG PET/CT after three and ten
      days of glucocorticoid treatment in the subset of LV-GCA patients and the diagnostic accuracy
      of 18F-FDG PET/CT in cranial artery inflammation in new-onset, treatment naïve c-GCA patients
      as compared to a control group of patients with a previous diagnosis of malignant melanoma
      was also evaluated and is registered elsewhere (ClinicalTrials.gov Identifier: NCT03285945
      and NCT03409913, respectively)
observational model: Cohort
time perspective: Prospective
measure: Diagnostic accuracy of large vessel ultrasound with PET/CT as reference
time frame: Time of diagnosis/pre-treatment
description: Large vessel ultrasound for LV-GCA diagnosis is considered positive in the presence of a halo in carotid and/or axillary arteries.
measure: Large vessel intima-media thickness (IMT) cut off for LV-GCA diagnosis with PET/CT as reference
time frame: Time of diagnosis/pre-treatment
description: IMT measurement performed on the distal vessel wall in carotid and axillary arteries
measure: Diagnostic accuracy vascular ultrasound (overall)
time frame: Time of diagnosis/pre-treatment
description: Vascular ultrasound for GCA diagnosis is considered positive in the presence of a halo in temporal, carotid and/or axillary arteries.
measure: Diagnostic accuracy of vascular ultrasound after treatment (day 3, 10 and week 8)
time frame: 3 days, 10 days and 8 weeks after initiated treatment
description: Vascular ultrasound for GCA diagnosis is considered positive in the presence of a halo in temporal, carotid and/or axillary arteries.
measure: Diagnostic accuracy of PET/CT of cranial arteries for c-GCA diagnosis (reference: American College of Rheumatology 1990 criteria)
time frame: Time of diagnosis/pre-treatment
description: cranial artery (vertebral, maxillary and temporal) FDG uptake above surrounding tissue FDG uptake is considered consistent with vasculitis
measure: Temporal artery biopsy
time frame: Time of diagnosis
description: Temporal artery biopsy considered positive in the presence of an inflammatory infiltrate in any vessel wall layer
measure: Halo sign for monitoring disease activity (week 8, 24 and 15 months)
time frame: week 8, 24 and 15 months after initiated treatment
description: Presence or absence of halos on US
measure: Composite halo score for monitoring disease activity (week 8, 24 and 15 months)
time frame: week 8, 24 and 15 months after initiated treatment
description: Composite halo score
measure: Intima media thickness for monitoring disease activity (week 8, 24 and 15 months)
time frame: week 8, 24 and 15 months after initiated treatment
description: Maximum intima media thickness (IMT) measurement on US
measure: PETVAS for monitoring disease activity (15 months)
time frame: 15 months after treatment is initiated
description: Composite PET scores (e.g.PETVAS)
measure: Semiquantitative FDG measure for monitoring disease activity (15 months)
time frame: 15 months after treatment is initiated
description: Maximum semiquantitative FDG measures
measure: FDG burden for monitoring disease activity (15 months)
time frame: 15 months after treatment is initiated
description: Composite scores of FDG inflammatory burden (summarising FDG uptake in voxels of interest)
measure: PETVAS for GCA prognosis (baseline)
time frame: 4-5 years after diagnosis
description: PETVAS score (summarising graded (1-4) FDG uptake in arterial vessel segments)
measure: Semiquantitative FDG measure for GCA prognosis (baseline)
time frame: 4-5 years after diagnosis
description: Maximum semiquantitative FDG measures
measure: FDG burden for GCA prognosis (baseline)
time frame: 4-5 years after diagnosis
description: Composite scores of arterial FDG uptake (summarising FDG uptake in voxels of interest)
measure: Aortic diameter 4-5 years after diagnosis
time frame: 4-5 years after diagnosis
description: Aortic diameter on cross sectional imaging
measure: Vessel wall thickening 4-5 years after diagnosis
time frame: 4-5 years after diagnosis
description: Vessel wall thickening
measure: Patient global NRS
time frame: Baseline, day 10, week 8, 24 and 15 months
description: Patients global experience of disease activity on a numerical range scale (0-10)
measure: Physician NRS
time frame: Baseline, day 10, week 8, 24 and 15 months
description: Physicians global judgement of disease activity on a numerical range scale (0-10)
measure: CRP
time frame: Baseline, day 3 and 10, week 8, 24 and 15 months
description: c-reactive protein (mg/l)
measure: Physicians judgement of disease activity
time frame: Baseline, day 10, week 8, 24 and 15 months
description: Overall judgement of disease activity (remission, possible activity not requiring treatment, activity/relapse)
measure: Cumulated glucocorticoid dose
time frame: Baseline, day 10, week 8, 24 and 15 months
description: Cumulated glucocorticoid dose (mg)
measure: Glucocorticoid dose
time frame: Baseline, day 10, week 8, 24 and 15 months
description: Glucocorticoid dose (mg)
measure: Cardiovascular events
time frame: 4-5 years
description: Cardiovascular events (number)
arm group label: GCA cases
description: GCA cases were patients with a clinical diagnosis of GCA based on a rheumatologists evaluation of history taking, physical examination, laboratory screening and initial PET report (reporting potential large vessel inflammation but not considering cranial artery inflammation).
GCA was considered large vessel (LV) and/or cranial (c) GCA cases:
LV-GCA cases were patients with a clinical diagnosis of GCA and verified LV inflammation by 18F-FDG PET/CT with or without concomitant c-GCA.
C-GCA cases, for the exploratory analysis of the performance of US and PET in c-GCA, were patients with a clinical diagnosis of GCA fulfilling the 1990 American College of Rheumatology (ACR) criteria, with or without concomitant LV-GCA.
arm group label: controls
description: Controls were GCA suspected patients in whom GCA diagnosis was dismissed.
intervention type: Diagnostic Test
intervention name: Ultrasound
description: Ultraosund of temporal, carotid and axillary arteries
arm group label: GCA cases
arm group label: controls
Full blood EDTA plasma Lithium-heparin plasma serum
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Berit Nielsen, MD
role: Principal Investigator
affiliation: Department of Rheumatology
responsible party type: Sponsor
mesh term: Polymyalgia Rheumatica
mesh term: Giant Cell Arteritis
mesh term: Vasculitis
mesh term: Arteritis
sharing ipd: No