<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/NCT03804112</url>
  </required_header>
  <id_info>
    <org_study_id>MOA_2018_2</org_study_id>
    <nct_id>NCT03804112</nct_id>
  </id_info>
  <brief_title>TransIent Perivascular Inflammation of the Carotid Artery (TIPIC) Syndrome: Clinical and Radiological Follow-up</brief_title>
  <acronym>TIPIC-UNV</acronym>
  <official_title>TransIent Perivascular Inflammation of the Carotid Artery (TIPIC) Syndrome: Clinical and Radiological Follow-up</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>
    <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>
      TIPIC syndrome (previously called carotidynia) is a rare entity of unknown cause, where the&#xD;
      patient has a temporary cervical pain associated with a suggestive inflammation around the&#xD;
      carotid artery. Usually considered as a unique and benign episode, some patients have&#xD;
      recurrences and the follow-up is usually short. In this study the investigators aim to&#xD;
      evaluate patients who presented a TIPIC episode at least 3 months before, clinically and with&#xD;
      a cervical doppler ultrasound&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 17, 2018</start_date>
  <completion_date type="Actual">February 18, 2020</completion_date>
  <primary_completion_date type="Actual">February 18, 2020</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>Assess the incidence of recurrence of TIPIC syndrome after a first episode</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <enrollment type="Actual">47</enrollment>
  <condition>Cervical Pain</condition>
  <condition>Vasculitis</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Ultrasound exam with Doppler</intervention_name>
    <description>Ultrasound exam of the neck to search a perivascular inflammation at the level of the carotid bifurcation.</description>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Blood samples</intervention_name>
    <description>blood count , CRP and viral serologies (herpes virus, chlamydia, mycoplasma),</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        all patient previously identified with a TIPC syndrom&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Patients with at least one episode of TIPIC syndrome for more than 12 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU de Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Pitié Salpêtrière</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Saint-Anne</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondation Ophtalmologique A. de Rothschild</name>
      <address>
        <city>Paris</city>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Toulouse</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de TOURS</name>
      <address>
        <city>Tours</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>June 20, 2021</last_update_submitted>
  <last_update_submitted_qc>June 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 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>Vasculitis</mesh_term>
    <mesh_term>Inflammation</mesh_term>
    <mesh_term>Neck Pain</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/NCT03804112
org study id: MOA_2018_2
nct id: NCT03804112
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
TIPIC syndrome (previously called carotidynia) is a rare entity of unknown cause, where the
      patient has a temporary cervical pain associated with a suggestive inflammation around the
      carotid artery. Usually considered as a unique and benign episode, some patients have
      recurrences and the follow-up is usually short. In this study the investigators aim to
      evaluate patients who presented a TIPIC episode at least 3 months before, clinically and with
      a cervical doppler ultrasound
observational model: Cohort
time perspective: Prospective
measure: Assess the incidence of recurrence of TIPIC syndrome after a first episode
time frame: 1 year
intervention type: Diagnostic Test
intervention name: Ultrasound exam with Doppler
description: Ultrasound exam of the neck to search a perivascular inflammation at the level of the carotid bifurcation.
intervention type: Biological
intervention name: Blood samples
description: blood count , CRP and viral serologies (herpes virus, chlamydia, mycoplasma),
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Vasculitis
mesh term: Inflammation
mesh term: Neck Pain