<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/NCT01674257</url>
  </required_header>
  <id_info>
    <org_study_id>MICA-V1.3</org_study_id>
    <secondary_id>PG/12/8/29371</secondary_id>
    <nct_id>NCT01674257</nct_id>
  </id_info>
  <brief_title>Metabolic Imaging in Carotid Atherosclerosis</brief_title>
  <acronym>MICA</acronym>
  <official_title>An Investigation of the Role of 18F-Sodium Fluoride and 18F-Flurodeoxyglucose PET CT and USPIO Enhanced MRI in Imaging Carotid Artery Inflammation and Mineralization.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Edinburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>NHS Lothian</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>British Heart Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Edinburgh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hardening of the arteries (atherosclerosis) is a common disorder that causes heart attacks&#xD;
      and strokes. PET CT and contrast-enhanced MRI scans are two new ways of assessing&#xD;
      atherosclerosis. The investigators propose to perform PET CT and MRI scans on patients with&#xD;
      hardening of the neck arteries due to undergo surgery to remove the hardened areas. The&#xD;
      investigators will then be able to compare the hot spots found on these scans with what the&#xD;
      investigators can see in the removed specimens under the microscope in the laboratory. This&#xD;
      will give investigators insight into the value of PET CT and MRI as tools for assessing&#xD;
      atherosclerosis. It will also provide the investigators with new information relating to the&#xD;
      underlying processes that give rise to atherosclerosis and will pave the way for the future&#xD;
      development of new treatments.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hardening of the arteries (atherosclerosis) is a very common health problem that can lead to&#xD;
      fatal or disabling heart attacks and strokes. On many levels, it remains an incompletely&#xD;
      understood illness.&#xD;
&#xD;
      Until relatively recently, the only way of assessing the severity of, or risk posed by,&#xD;
      atherosclerosis was to measure the degree to which it narrowed a particular blood vessel.&#xD;
      This method only tells part of the story; he investigators now know that frequently the&#xD;
      'culprit area' of atherosclerosis that causes the heart attack or stroke does not necessarily&#xD;
      result in narrowing of the blood vessel - i.e. if the investigators only measure narrowness&#xD;
      the investigators will miss lots of 'bad' atherosclerosis. As such, there is a pressing need&#xD;
      to identify more sophisticated techniques of assessing the disease in order that people who&#xD;
      are at higher risk of heart attack or stroke can be identified early and offered appropriate&#xD;
      preventative treatment.&#xD;
&#xD;
      Techniques that provide this extra information could also significantly shorten the time it&#xD;
      takes to get new treatments and drugs to market by providing a faster and more cost-effective&#xD;
      way of assessing these treatments early in their development. Furthermore, in exploring new&#xD;
      techniques that reflect more accurately what is going on within atherosclerosis in the body,&#xD;
      deeper insight into the condition will be gained. This will in turn lead to the development&#xD;
      of new treatments.&#xD;
&#xD;
      PET/CT scans and USPIO (a kind of tracer) enhanced MRI scans are two such techniques that&#xD;
      demonstrate particular promise. These scanning methods not only provide more information&#xD;
      about the composition and architecture of the atherosclerosis but can provide data about the&#xD;
      processes (at the chemical and cellular level) that underlie the disease.&#xD;
&#xD;
      Inflammation and calcification (deposits of calcium) are two biological processes that are&#xD;
      known to be very important in the genesis of atherosclerosis. PET/CT and USPIO enhanced MRI&#xD;
      can detect these processes.&#xD;
&#xD;
      Most strokes and mini-strokes are caused by a narrowing in the neck artery. If a patient with&#xD;
      mini-stroke or stroke has a narrowing (atherosclerosis) in their carotid artery they are&#xD;
      normally offered an operation to remove the atherosclerosis (endarterectomy), the piece of&#xD;
      atherosclerosis is then normally discarded. This scenario affords a perfect opportunity to&#xD;
      explore new scanning techniques.&#xD;
&#xD;
      The investigators propose to explore the feasibility and value of using PET/CT (using 18F-FDG&#xD;
      and 18F-NaF - two tracers known to highlight inflammation and calcification) and USPIO&#xD;
      enhanced MRI to assess atherosclerosis. The investigators will do this by scanning patients&#xD;
      who have just had a mini-stroke or minor stroke and are due to undergo endarterectomy. The&#xD;
      investigators will then be able to define what is going on at the level of the genes and the&#xD;
      cells that causes 'hot spots' on CT/PET and MRI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2013</start_date>
  <completion_date type="Anticipated">September 2014</completion_date>
  <primary_completion_date type="Anticipated">July 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>The Standardized Uptake Value (SUV) for 18F-Fluoride of the ipsilateral carotid artery</measure>
    <time_frame>1-2 days after PET/CT scan</time_frame>
    <description>The mean and maximum SUV (using 18F-NaF) of the ipsilateral carotid artery will be calculated and compared to its contra lateral partner. The SUV is a validated quantitative assessment of PET radiotracer uptake.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The SUV of 18F-Flurodeoxyglucose on PET/CT of the ipsilateral carotid artery</measure>
    <time_frame>1-2 days after PET/CT scan</time_frame>
    <description>The mean and maximum SUV (using 18F-Flurodeoxyglucose) of the ipsilateral carotid artery will be calculated and compared to its contra lateral partner.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>A correlation between the ipsilateral carotid SUV of 18F-Flurodeoxyglucose and tissue markers of inflammation and apoptosis.</measure>
    <time_frame>Approximately 1 month after PET/CT scan</time_frame>
    <description>Sections of excised atheroma that demonstrate uptake of 18F-Flurodeoxyglucose will be subjected to histological examination. A variety of immunohistochemical markers of inflammation and apoptosis will be quantitatively assessed for correlation with the degree of radioligand uptake. Tissue showing no radioligand uptake will be used as control.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>A correlation between ipsilateral carotid SUV of 18F-Fluoride and the gene expression characteristics of excised plaque.</measure>
    <time_frame>Approximately 1 month after the PET/CT scan</time_frame>
    <description>Sections of excised atheroma that demonstrate uptake of 18F-Fluoride will be subjected to gene expression profiling. Sections of plaque that do not show uptake will be used as controls. The resulting data will be analyzed to explore the variation in gene expression between subjects and between areas of differing radioligand uptake. Genes of particular interest (either identified during expression profiling or selected beforehand) will be further studied using quantitative PCR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>A correlation between the ipsilateral carotid SUV of 18F-Fluoride and tissue markers of apoptosis and calcification.</measure>
    <time_frame>Approximately 1 month after the PET/CT scan</time_frame>
    <description>Sections of excised atheroma that demonstrate uptake of 18F-Fluoride will be subjected to histological examination. A variety of immunohistochemical markers of calcification and apoptosis will be quantitatively assessed for correlation with the degree of radioligand uptake. Tissue showing no radioligand uptake will be used as control.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The presence or absence of USPIO (ultra-small superparamagnetic particles of iron oxide) uptake on MRI (magnetic resonance image) within the ipsilateral carotid artery compared to its contralateral partner.</measure>
    <time_frame>1-2 days after MRI scan</time_frame>
    <description>USPIOs are known to accumulate within activated macrophages in inflamed atheroma. This causes a demonstrable drop in T2* signal on MR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>A correlation between the ipsilateral carotid USPIO uptake and tissue markers of inflammation and apoptosis.</measure>
    <time_frame>1 month after MRI scan</time_frame>
    <description>Sections of excised atheroma will be co-stained for USPIO and a variety of immunohistochemical markers of inflammation and apoptosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>A correlation between the ipsilateral carotid USPIO uptake and gene expression characteristics of excised atheroma.</measure>
    <time_frame>1 month after the MRI scan</time_frame>
    <description>Sections of excised atheroma that demonstrate uptake of USPIO will be subjected to gene expression profiling. Sections of plaque that do not show uptake will be used as controls. The resulting data will be analyzed to explore the variation in gene expression between subjects and between areas of differing USPIO uptake. Genes of particular interest (either identified during expression profiling or selected beforehand) will be further studied using quantitative PCR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The ipsilateral carotid radioactivity, arterial blood radioactivity and whole blood fluoride concentration measured over time</measure>
    <time_frame>During the 18F PET/CT scan</time_frame>
    <description>The kinetics of 18F-Fluoride in atherosclerosis have not yet been defined. Using data from the PET scanner in list mode and regular arterial and venous blood sampling in 20 patients (a subset of the total) we will define a model describing the radiopharmacokinetics of 18F-Fluoride in carotid atheroma.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Atherosclerosis</condition>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Carotid Endarterectomy</arm_group_label>
    <description>Patients due to undergo carotid endarterectomy for symptomatic carotid artery stenosis will undergo an 18F-Fluoride PET/CT, an 18F-Flurodeoxyglucose PET/CT and a USPIO (ferumoxytol)-enhanced MRI scan (2 MRI scans).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>USPIO (ferumoxytol)-enhanced MRI scan</intervention_name>
    <description>Two separate MRI scans will form this intervention. A baseline scan followed by an infusion of USPIO (ferumoxytol), followed by another MRI scan.</description>
    <arm_group_label>Carotid Endarterectomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>18f-Fluoride PET/CT scan</intervention_name>
    <arm_group_label>Carotid Endarterectomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>18F-Flurodeoxyglucose PET/CT scan</intervention_name>
    <arm_group_label>Carotid Endarterectomy</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood and excised carotid atheroma&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients referred for carotid endarterectomy for symptomatic carotid artery stenosis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with carotid stenosis due to undergo carotid endarterectomy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with new stroke and a modified Rankin score &gt;3&#xD;
&#xD;
          -  Chronic Kidney Disease with eGFR of &lt;30 mL/min/1.73m2&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Poorly controlled diabetes mellitus (HbA1c &gt; 8.5%) or diabetes mellitus requiring&#xD;
             insulin&#xD;
&#xD;
          -  Prior ipsilateral carotid intervention&#xD;
&#xD;
          -  Prior neck irradiation&#xD;
&#xD;
          -  Inability to tolerate the supine position&#xD;
&#xD;
          -  Participation in the study would result in delay to surgery&#xD;
&#xD;
          -  Psychiatric illness/social situations that would limit compliance with study&#xD;
             requirements&#xD;
&#xD;
          -  Specific contraindications to MRI (e.g. pacemaker)&#xD;
&#xD;
          -  History of allergic reaction attributed to ferumoxytol or similar&#xD;
&#xD;
          -  Known or suspected iron overload (genetic haemochromatosis or history of multiple&#xD;
             transfusions)&#xD;
&#xD;
          -  History of allergic reaction attributed to 18F-FDG or 18F-NaF or similar&#xD;
&#xD;
          -  History of allergic reaction to iodine or iodine-based contrast media&#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>David E Newby, DSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Edinburgh</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Alex T Vesey, MB/ChB</last_name>
    <phone>00447795634522</phone>
    <email>avesey@staffmail.ed.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>David E Newby, DSc</last_name>
    <email>D.E.Newby@ed.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Clinical Research Imaging Centre</name>
      <address>
        <city>Edinburgh</city>
        <zip>EH16 4TJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alex T Vesey, MB/ChB</last_name>
      <phone>00447795634522</phone>
      <email>avesey@staffmail.ed.ac.uk</email>
    </contact>
    <investigator>
      <last_name>Alex T Vesey, MB/ChB</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2013</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>March 5, 2013</last_update_submitted>
  <last_update_submitted_qc>March 5, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 6, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Atherosclerosis</keyword>
  <keyword>Stroke</keyword>
  <keyword>Positron-emission tomography</keyword>
  <keyword>Ferumoxytol</keyword>
  <keyword>Magnetic resonance imaging</keyword>
  <keyword>Genetics</keyword>
  <keyword>Calcification</keyword>
  <keyword>Inflammation</keyword>
  <keyword>Flurodeoxyglucose F18</keyword>
  <keyword>Radiopharmaceuticals</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atherosclerosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ferrosoferric Oxide</mesh_term>
    <mesh_term>Fluorides</mesh_term>
  </intervention_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/NCT01674257
org study id: MICA-V1.3
secondary id: PG/12/8/29371
nct id: NCT01674257
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Hardening of the arteries (atherosclerosis) is a common disorder that causes heart attacks
      and strokes. PET CT and contrast-enhanced MRI scans are two new ways of assessing
      atherosclerosis. The investigators propose to perform PET CT and MRI scans on patients with
      hardening of the neck arteries due to undergo surgery to remove the hardened areas. The
      investigators will then be able to compare the hot spots found on these scans with what the
      investigators can see in the removed specimens under the microscope in the laboratory. This
      will give investigators insight into the value of PET CT and MRI as tools for assessing
      atherosclerosis. It will also provide the investigators with new information relating to the
      underlying processes that give rise to atherosclerosis and will pave the way for the future
      development of new treatments.
Hardening of the arteries (atherosclerosis) is a very common health problem that can lead to
      fatal or disabling heart attacks and strokes. On many levels, it remains an incompletely
      understood illness.

      Until relatively recently, the only way of assessing the severity of, or risk posed by,
      atherosclerosis was to measure the degree to which it narrowed a particular blood vessel.
      This method only tells part of the story; he investigators now know that frequently the
      'culprit area' of atherosclerosis that causes the heart attack or stroke does not necessarily
      result in narrowing of the blood vessel - i.e. if the investigators only measure narrowness
      the investigators will miss lots of 'bad' atherosclerosis. As such, there is a pressing need
      to identify more sophisticated techniques of assessing the disease in order that people who
      are at higher risk of heart attack or stroke can be identified early and offered appropriate
      preventative treatment.

      Techniques that provide this extra information could also significantly shorten the time it
      takes to get new treatments and drugs to market by providing a faster and more cost-effective
      way of assessing these treatments early in their development. Furthermore, in exploring new
      techniques that reflect more accurately what is going on within atherosclerosis in the body,
      deeper insight into the condition will be gained. This will in turn lead to the development
      of new treatments.

      PET/CT scans and USPIO (a kind of tracer) enhanced MRI scans are two such techniques that
      demonstrate particular promise. These scanning methods not only provide more information
      about the composition and architecture of the atherosclerosis but can provide data about the
      processes (at the chemical and cellular level) that underlie the disease.

      Inflammation and calcification (deposits of calcium) are two biological processes that are
      known to be very important in the genesis of atherosclerosis. PET/CT and USPIO enhanced MRI
      can detect these processes.

      Most strokes and mini-strokes are caused by a narrowing in the neck artery. If a patient with
      mini-stroke or stroke has a narrowing (atherosclerosis) in their carotid artery they are
      normally offered an operation to remove the atherosclerosis (endarterectomy), the piece of
      atherosclerosis is then normally discarded. This scenario affords a perfect opportunity to
      explore new scanning techniques.

      The investigators propose to explore the feasibility and value of using PET/CT (using 18F-FDG
      and 18F-NaF - two tracers known to highlight inflammation and calcification) and USPIO
      enhanced MRI to assess atherosclerosis. The investigators will do this by scanning patients
      who have just had a mini-stroke or minor stroke and are due to undergo endarterectomy. The
      investigators will then be able to define what is going on at the level of the genes and the
      cells that causes 'hot spots' on CT/PET and MRI.
observational model: Cohort
time perspective: Prospective
measure: The Standardized Uptake Value (SUV) for 18F-Fluoride of the ipsilateral carotid artery
time frame: 1-2 days after PET/CT scan
description: The mean and maximum SUV (using 18F-NaF) of the ipsilateral carotid artery will be calculated and compared to its contra lateral partner. The SUV is a validated quantitative assessment of PET radiotracer uptake.
measure: The SUV of 18F-Flurodeoxyglucose on PET/CT of the ipsilateral carotid artery
time frame: 1-2 days after PET/CT scan
description: The mean and maximum SUV (using 18F-Flurodeoxyglucose) of the ipsilateral carotid artery will be calculated and compared to its contra lateral partner.
measure: A correlation between the ipsilateral carotid SUV of 18F-Flurodeoxyglucose and tissue markers of inflammation and apoptosis.
time frame: Approximately 1 month after PET/CT scan
description: Sections of excised atheroma that demonstrate uptake of 18F-Flurodeoxyglucose will be subjected to histological examination. A variety of immunohistochemical markers of inflammation and apoptosis will be quantitatively assessed for correlation with the degree of radioligand uptake. Tissue showing no radioligand uptake will be used as control.
measure: A correlation between ipsilateral carotid SUV of 18F-Fluoride and the gene expression characteristics of excised plaque.
time frame: Approximately 1 month after the PET/CT scan
description: Sections of excised atheroma that demonstrate uptake of 18F-Fluoride will be subjected to gene expression profiling. Sections of plaque that do not show uptake will be used as controls. The resulting data will be analyzed to explore the variation in gene expression between subjects and between areas of differing radioligand uptake. Genes of particular interest (either identified during expression profiling or selected beforehand) will be further studied using quantitative PCR.
measure: A correlation between the ipsilateral carotid SUV of 18F-Fluoride and tissue markers of apoptosis and calcification.
time frame: Approximately 1 month after the PET/CT scan
description: Sections of excised atheroma that demonstrate uptake of 18F-Fluoride will be subjected to histological examination. A variety of immunohistochemical markers of calcification and apoptosis will be quantitatively assessed for correlation with the degree of radioligand uptake. Tissue showing no radioligand uptake will be used as control.
measure: The presence or absence of USPIO (ultra-small superparamagnetic particles of iron oxide) uptake on MRI (magnetic resonance image) within the ipsilateral carotid artery compared to its contralateral partner.
time frame: 1-2 days after MRI scan
description: USPIOs are known to accumulate within activated macrophages in inflamed atheroma. This causes a demonstrable drop in T2* signal on MR.
measure: A correlation between the ipsilateral carotid USPIO uptake and tissue markers of inflammation and apoptosis.
time frame: 1 month after MRI scan
description: Sections of excised atheroma will be co-stained for USPIO and a variety of immunohistochemical markers of inflammation and apoptosis.
measure: A correlation between the ipsilateral carotid USPIO uptake and gene expression characteristics of excised atheroma.
time frame: 1 month after the MRI scan
description: Sections of excised atheroma that demonstrate uptake of USPIO will be subjected to gene expression profiling. Sections of plaque that do not show uptake will be used as controls. The resulting data will be analyzed to explore the variation in gene expression between subjects and between areas of differing USPIO uptake. Genes of particular interest (either identified during expression profiling or selected beforehand) will be further studied using quantitative PCR.
measure: The ipsilateral carotid radioactivity, arterial blood radioactivity and whole blood fluoride concentration measured over time
time frame: During the 18F PET/CT scan
description: The kinetics of 18F-Fluoride in atherosclerosis have not yet been defined. Using data from the PET scanner in list mode and regular arterial and venous blood sampling in 20 patients (a subset of the total) we will define a model describing the radiopharmacokinetics of 18F-Fluoride in carotid atheroma.
arm group label: Carotid Endarterectomy
description: Patients due to undergo carotid endarterectomy for symptomatic carotid artery stenosis will undergo an 18F-Fluoride PET/CT, an 18F-Flurodeoxyglucose PET/CT and a USPIO (ferumoxytol)-enhanced MRI scan (2 MRI scans).
intervention type: Other
intervention name: USPIO (ferumoxytol)-enhanced MRI scan
description: Two separate MRI scans will form this intervention. A baseline scan followed by an infusion of USPIO (ferumoxytol), followed by another MRI scan.
arm group label: Carotid Endarterectomy
intervention type: Radiation
intervention name: 18f-Fluoride PET/CT scan
arm group label: Carotid Endarterectomy
intervention type: Radiation
intervention name: 18F-Flurodeoxyglucose PET/CT scan
arm group label: Carotid Endarterectomy
Blood and excised carotid atheroma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David E Newby, DSc
role: Principal Investigator
affiliation: University of Edinburgh
last name: Alex T Vesey, MB/ChB
phone: 00447795634522
email: avesey@staffmail.ed.ac.uk
last name: David E Newby, DSc
email: D.E.Newby@ed.ac.uk
facility: 
status: Recruiting
contact: 
investigator: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Atherosclerosis
mesh term: Ferrosoferric Oxide
mesh term: Fluorides