<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/NCT01709045</url>
  </required_header>
  <id_info>
    <org_study_id>10-2-048</org_study_id>
    <nct_id>NCT01709045</nct_id>
  </id_info>
  <brief_title>ParisK: Correlation of Imaging Techniques With Histology</brief_title>
  <acronym>ParisK</acronym>
  <official_title>The Assessment of the Plaque at RISK by Non-invasive (Molecular) Imaging and Modelling (ParisK): Correlation of Imaging Techniques With Histology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Center for Translational Molecular Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dutch Heart Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Maastricht University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The possibility to identify the risk of rupture of a carotid plaque will have tremendous&#xD;
      impact in clinical decision making. A vulnerable plaque is considered to have a large lipid&#xD;
      rich necrotic core (LRNC), a thin fibrous cap, the presence of inflammatory cells,&#xD;
      intraplaque haemorrhage and/or neovascularisation (vasa vasorum). The investigators aim to&#xD;
      validate imaging of plaque vulnerability with histology. Previous studies have evaluated the&#xD;
      use of imaging to assess carotid plaque vulnerability, mostly showing a good correlation&#xD;
      between imaging and histology and/or clinical characteristics. However, they have focused on&#xD;
      single modalities, (magnetic resonance imaging [MRI], multidetector-row computed tomography&#xD;
      (MDCT), ultrasonography (US) or transcranial Doppler (TCD), and have used relatively small&#xD;
      cohorts&#xD;
&#xD;
      The primary goal of this study is to investigate whether there is a correlation between&#xD;
      neovascularisation in the carotid atherosclerotic plaque as observed with 3.0 Tesla dynamic&#xD;
      contrast-enhanced MRI and histology. Moreover, the investigators aim to investigate the&#xD;
      correlation between the volume of the LRNC as determined by dual-energy CT and histology.&#xD;
&#xD;
      Secondly, the investigators will investigate the correlation between the volume of the LRNC,&#xD;
      the fibrous cap status and the volume of the calcifications determined by MRI versus&#xD;
      histology, the correlation between number of microembolisms and fibrous cap status and the&#xD;
      correlation between the deformation pattern seen with ultrasound and the volume of the LRNC.&#xD;
&#xD;
      The imaging parameters showing good correlation with plaque vulnerability characteristics can&#xD;
      be used for further analysis in assessing the vulnerable plaque&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2011</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2014</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>Ktrans on dynamic contrast-enhanced (DCE)-MRI</measure>
    <time_frame>1 day</time_frame>
    <description>The correlation between neovascularisation in carotid atherosclerotic plaque as assessed by dynamic 3.0 Tesla MRI and microvasculature as assessed by histology.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lipid-rich necrotic core on dual-energy CT</measure>
    <time_frame>1 day</time_frame>
    <description>The correlation between the size of lipid-rich-necrotic-core in dual-energy CT and histology.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>deformation pattern on ultrasound</measure>
    <time_frame>1 day</time_frame>
    <description>The correlation between deformation pattern at echo and plaque composition (volume of LRNC) at histology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of recorded micro embolic signals (MES)</measure>
    <time_frame>1 day</time_frame>
    <description>The relation between number of recorded MES and fibrous cap status at histology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of LRNC and calcifications and fibrous cap status on MRI</measure>
    <time_frame>1 day</time_frame>
    <description>The correlation between volume of LRNC, fibrous cap status and volume of calcifications in carotid atherosclerotic plaques visualised by MRI and the same features as determined at histology.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Stroke</condition>
  <condition>Plaque, Atherosclerotic</condition>
  <arm_group>
    <arm_group_label>Patients scheduled for CEA</arm_group_label>
    <description>All patients who are scheduled for carotid endarterectomy (CEA)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Magnetic Resonance Imaging (MRI)</intervention_name>
    <description>Multi-sequence MR protocol</description>
    <arm_group_label>Patients scheduled for CEA</arm_group_label>
    <other_name>3.0 T Philips Achieva</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Dual-Energy Computed Tomography (DECT)</intervention_name>
    <arm_group_label>Patients scheduled for CEA</arm_group_label>
    <other_name>Siemens Flash</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ultrasound</intervention_name>
    <arm_group_label>Patients scheduled for CEA</arm_group_label>
    <other_name>Philips IU22</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Transcranial doppler</intervention_name>
    <arm_group_label>Patients scheduled for CEA</arm_group_label>
    <other_name>Hemodynamics AG</other_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Carotid plaque removed during carotid endarterectomy&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with a carotid artery stenosis, who are scheduled for carotid endarterectomy, will&#xD;
        be included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a carotid artery stenosis, who are scheduled for carotid endarterectomy&#xD;
&#xD;
          -  Age 18 years or older (no maximum age)&#xD;
&#xD;
          -  Informed consent by signing informed consent form regarding this study&#xD;
&#xD;
          -  Inclusion criteria for carotid endarterectomy&#xD;
&#xD;
               1. Symptomatic carotid artery stenosis 70-99% within 3 months of neurological&#xD;
                  symptoms&#xD;
&#xD;
               2. Symptomatic carotid artery stenosis 50-99% in man within 2 weeks of neurological&#xD;
                  symptoms&#xD;
&#xD;
               3. Asymptomatic carotid artery stenosis 70-99% with contralateral occlusion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe co-morbidity, dementia or pregnancy&#xD;
&#xD;
          -  Standard contra-indications for MRI (ferromagnetic implants like pacemakers or other&#xD;
             electronic implants, metallic eye fragments, vascular clips, claustrophobia, etc.)&#xD;
&#xD;
          -  Patients who have a documented allergy to MRI or CT contrast media&#xD;
&#xD;
          -  Patients with a renal clearance &lt;30 ml/min are not eligible to undergo&#xD;
             contrast-enhanced MRI&#xD;
&#xD;
          -  Patients with a renal clearance &lt;60 ml/min are not eligible to undergo CT&#xD;
&#xD;
          -  Surgery planned within 4 days of inclusion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eline Kooi, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Maastricht University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maastricht University Medical Center</name>
      <address>
        <city>Maastricht</city>
        <state>Limburg</state>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eline Kooi, PhD</last_name>
      <email>eline.kooi@mumc.nl</email>
    </contact>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>September 2013</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 17, 2012</study_first_posted>
  <last_update_submitted>September 12, 2013</last_update_submitted>
  <last_update_submitted_qc>September 12, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 13, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Endarterectomy, Carotid</keyword>
  <keyword>Carotid Arteries</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Plaque, Atherosclerotic</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/NCT01709045
org study id: 10-2-048
nct id: NCT01709045
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The possibility to identify the risk of rupture of a carotid plaque will have tremendous
      impact in clinical decision making. A vulnerable plaque is considered to have a large lipid
      rich necrotic core (LRNC), a thin fibrous cap, the presence of inflammatory cells,
      intraplaque haemorrhage and/or neovascularisation (vasa vasorum). The investigators aim to
      validate imaging of plaque vulnerability with histology. Previous studies have evaluated the
      use of imaging to assess carotid plaque vulnerability, mostly showing a good correlation
      between imaging and histology and/or clinical characteristics. However, they have focused on
      single modalities, (magnetic resonance imaging [MRI], multidetector-row computed tomography
      (MDCT), ultrasonography (US) or transcranial Doppler (TCD), and have used relatively small
      cohorts

      The primary goal of this study is to investigate whether there is a correlation between
      neovascularisation in the carotid atherosclerotic plaque as observed with 3.0 Tesla dynamic
      contrast-enhanced MRI and histology. Moreover, the investigators aim to investigate the
      correlation between the volume of the LRNC as determined by dual-energy CT and histology.

      Secondly, the investigators will investigate the correlation between the volume of the LRNC,
      the fibrous cap status and the volume of the calcifications determined by MRI versus
      histology, the correlation between number of microembolisms and fibrous cap status and the
      correlation between the deformation pattern seen with ultrasound and the volume of the LRNC.

      The imaging parameters showing good correlation with plaque vulnerability characteristics can
      be used for further analysis in assessing the vulnerable plaque
observational model: Cohort
time perspective: Prospective
measure: Ktrans on dynamic contrast-enhanced (DCE)-MRI
time frame: 1 day
description: The correlation between neovascularisation in carotid atherosclerotic plaque as assessed by dynamic 3.0 Tesla MRI and microvasculature as assessed by histology.
measure: Lipid-rich necrotic core on dual-energy CT
time frame: 1 day
description: The correlation between the size of lipid-rich-necrotic-core in dual-energy CT and histology.
measure: deformation pattern on ultrasound
time frame: 1 day
description: The correlation between deformation pattern at echo and plaque composition (volume of LRNC) at histology.
measure: number of recorded micro embolic signals (MES)
time frame: 1 day
description: The relation between number of recorded MES and fibrous cap status at histology.
measure: Volume of LRNC and calcifications and fibrous cap status on MRI
time frame: 1 day
description: The correlation between volume of LRNC, fibrous cap status and volume of calcifications in carotid atherosclerotic plaques visualised by MRI and the same features as determined at histology.
arm group label: Patients scheduled for CEA
description: All patients who are scheduled for carotid endarterectomy (CEA)
intervention type: Other
intervention name: Magnetic Resonance Imaging (MRI)
description: Multi-sequence MR protocol
arm group label: Patients scheduled for CEA
other name: 3.0 T Philips Achieva
intervention type: Radiation
intervention name: Dual-Energy Computed Tomography (DECT)
arm group label: Patients scheduled for CEA
other name: Siemens Flash
intervention type: Other
intervention name: Ultrasound
arm group label: Patients scheduled for CEA
other name: Philips IU22
intervention type: Other
intervention name: Transcranial doppler
arm group label: Patients scheduled for CEA
other name: Hemodynamics AG
Carotid plaque removed during carotid endarterectomy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eline Kooi, PhD
role: Study Chair
affiliation: Maastricht University Medical Center
facility: 
status: Recruiting
contact: 
country: Netherlands
responsible party type: Sponsor
mesh term: Plaque, Atherosclerotic