<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/NCT02265250</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00037025</org_study_id>
    <nct_id>NCT02265250</nct_id>
  </id_info>
  <brief_title>Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment</brief_title>
  <official_title>Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cedars-Sinai Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cedars-Sinai Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cardiovascular disease (CVD) remains the leading cause of death in the United States, and&#xD;
      improved CVD risk assessment is needed for personalized medicine. Atherosclerosis measures&#xD;
      including plaque volume and adverse plaque features have prognostic value. Novel techniques&#xD;
      have been developed for assessing carotid, coronary, and femoral atherosclerosis using&#xD;
      magnetic resonance imaging (MRI) methods that are rapid and reproducible, have improved&#xD;
      spatial resolution, and do not require contrast media, making atherosclerosis assessment in&#xD;
      multiple vascular beds feasible during a single MRI session. This pilot research will provide&#xD;
      preliminary data to develop an innovative global atherosclerosis measure including carotid,&#xD;
      coronary, and femoral vascular beds, for assessing cardiovascular risk and for monitoring&#xD;
      atherosclerosis response to therapy. 20 participants will be recruited in one year.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There are up to 2 study visits in this study.&#xD;
&#xD;
      During the first visit, the investigators will obtain non-contrast MRI (carotid, coronary,&#xD;
      and femoral) in 20 subjects with known coronary atherosclerosis but varying degrees of CVD&#xD;
      risk.&#xD;
&#xD;
        1. 5 asymptomatic subjects with lower CVD risk (recent coronary artery calcium score [CACS]&#xD;
           10-299)&#xD;
&#xD;
        2. 5 asymptomatic subjects with higher CVD risk (CACS 300-1000)&#xD;
&#xD;
        3. 5 subjects with known coronary atherosclerosis and stable angina&#xD;
&#xD;
        4. 5 subjects with known atherosclerosis and recent acute myocardial infarction&#xD;
&#xD;
      The investigators will measure plaque volume and assess adverse plaque features (intra-plaque&#xD;
      hemorrhage, positive remodeling, lesion eccentricity) in the three vascular beds.&#xD;
&#xD;
      Eight of these subjects with evidence of large plaque burden by MRI will be asked to return&#xD;
      for a simultaneous positron emission tomography (PET)-MRI imaging with 18F-sodium fluoride&#xD;
      (18F-NaF) of their carotid, coronary, and femoral arteries, in which 18F-NaF uptake in plaque&#xD;
      will represent micro-calcifications, which is associated with high-risk plaque.&#xD;
&#xD;
      In all 20 subjects, the investigators will also measure the following biomarkers which have&#xD;
      been shown to be useful for CVD risk assessment of atherosclerosis: LDL, HDL, lipoprotein(a),&#xD;
      apolipoprotein B/A-1 ratio, hemoglobin A1c, adiponectin, and highly sensitive C-reactive&#xD;
      protein. The investigators will also calculate their estimated 10-year and lifetime&#xD;
      atherosclerotic CVD risk (American Heart Association), Framingham 10-year CVD risk, and&#xD;
      Reynolds 10-year CVD risk scores.&#xD;
&#xD;
      We aim to obtain the second scan within 3 months of the first visit; thus, the subjects will&#xD;
      participate in the study for approximately 3 months.&#xD;
&#xD;
      All the procedures are research-related. The research visit will take approximately 3 hours,&#xD;
      and there will be maximum two visits. There are no collaborations with other sites.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">October 2024</completion_date>
  <primary_completion_date type="Anticipated">October 2024</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>Plaque Volume</measure>
    <time_frame>24 hours</time_frame>
    <description>Quantitative plaque measurement using MRI software (VesselMass)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse plaque features</measure>
    <time_frame>24 hours</time_frame>
    <description>Presence of positive remodeling, lesion eccentricity, and intraplaque hemorrhage of plaque, on MRI</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>18F-NaF PET uptake</measure>
    <time_frame>3-6 months</time_frame>
    <description>Measured as maximum tissue/background ratio (TBR), to assess for high-risk plaque</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory biomarkers</measure>
    <time_frame>24 hours</time_frame>
    <description>Measured as levels of LDL-C, HDL-C, lipoprotein(a), ApoB/ApoA-1 ratio, hemoglobin A1c, plasma adiponectin, hsCRP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical risk scores</measure>
    <time_frame>24 hours</time_frame>
    <description>Measured as (1) ACC/AHA 10-year and lifetime atherosclerotic CVD risk, (2) Framingham 10-year CVD risk, and (3) Reynolds Risk 10-year CVD risk</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Cardiovascular Disease</condition>
  <condition>Atherosclerosis</condition>
  <arm_group>
    <arm_group_label>Asymptomatic, CACS &lt;300</arm_group_label>
    <description>5 asymptomatic subjects with low CVD risk, defined as recent coronary artery calcium score (CACS) &lt;300&#xD;
Noncontrast MRI of the bilateral carotid, coronary, and superficial femoral arteries; Laboratory blood test (cardiovascular biomarkers)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Asymptomatic, CACS ≥300</arm_group_label>
    <description>5 asymptomatic subjects with increased CVD risk, defined as a recent coronary artery calcium score (CACS) ≥300&#xD;
Noncontrast MRI of the bilateral carotid, coronary, and superficial femoral arteries; Laboratory blood test (cardiovascular biomarkers); Simultaneous 18F-NaF PET/MRI of the bilateral carotid, coronary, and superficial femoral arteries</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stable angina</arm_group_label>
    <description>5 subjects with stable angina and evidence of coronary atherosclerosis based on a recent invasive or CT coronary angiogram&#xD;
Noncontrast MRI of the bilateral carotid, coronary, and superficial femoral arteries; Laboratory blood test (cardiovascular biomarkers); Simultaneous 18F-NaF PET/MRI of the bilateral carotid, coronary, and superficial femoral arteries</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Recent acute MI</arm_group_label>
    <description>5 subjects with a recent acute myocardial infarction (within 1 month) and evidence of coronary atherosclerosis based on invasive or CT coronary angiogram&#xD;
Noncontrast MRI of the bilateral carotid, coronary, and superficial femoral arteries; Laboratory blood test (cardiovascular biomarkers); Simultaneous 18F-NaF PET/MRI of the bilateral carotid, coronary, and superficial femoral arteries</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MRI</intervention_name>
    <description>Noncontrast T1- and T2-weighted 3.0 T MRI of the bilateral carotid, coronary, and superficial femoral arteries</description>
    <arm_group_label>Asymptomatic, CACS &lt;300</arm_group_label>
    <arm_group_label>Asymptomatic, CACS ≥300</arm_group_label>
    <arm_group_label>Recent acute MI</arm_group_label>
    <arm_group_label>Stable angina</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PET/MRI</intervention_name>
    <description>Simultaneous 18F-NaF PET/MRI of the bilateral carotid, coronary, and superficial femoral arteries</description>
    <arm_group_label>Asymptomatic, CACS ≥300</arm_group_label>
    <arm_group_label>Recent acute MI</arm_group_label>
    <arm_group_label>Stable angina</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory blood test</intervention_name>
    <description>Cardiovascular biomarkers</description>
    <arm_group_label>Asymptomatic, CACS &lt;300</arm_group_label>
    <arm_group_label>Asymptomatic, CACS ≥300</arm_group_label>
    <arm_group_label>Recent acute MI</arm_group_label>
    <arm_group_label>Stable angina</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      We will obtain fasting lipid and inflammatory biomarkers (LDL-C, HDL-C, lipoprotein(a),&#xD;
      ApoB/ApoA-1 ratio, hemoglobin A1c, plasma adiponectin, hsCRP).&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        20 subjects with known coronary atherosclerosis but varying degrees of CVD risk&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men and women with evidence of coronary atherosclerosis based on a recent CACS 10-1000&#xD;
             or an invasive or CT coronary angiogram (within 6 weeks of recruitment)&#xD;
&#xD;
          2. No planned revascularization procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Contraindications to MRI&#xD;
&#xD;
          2. Pregnant and lactating women&#xD;
&#xD;
          3. Body mass index (BMI)&gt;40&#xD;
&#xD;
          4. Active smoking&#xD;
&#xD;
          5. Resting heart rate&gt;75 beats per minute&#xD;
&#xD;
          6. Arrhythmia&#xD;
&#xD;
          7. Prior carotid/coronary/peripheral revascularization&#xD;
&#xD;
          8. Life expectancy &lt;5 years&#xD;
&#xD;
          9. Allergy to animal dander&#xD;
&#xD;
         10. Severe asthma&#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>Janet Wei, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cedars-Sinai Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Noel Bairey Merz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cedars-Sinai Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Denisse Barajas</last_name>
    <phone>310-423-9666</phone>
    <email>denisse.barajas@cshs.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ying Mou, PhD</last_name>
      <phone>310-248-7669</phone>
      <email>ying.mou@cshs.org</email>
    </contact>
    <contact_backup>
      <last_name>Sophie Yoo, MS</last_name>
      <phone>424-315-4306</phone>
      <email>Jihye.Yoo@cshs.org</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>October 3, 2014</study_first_submitted>
  <study_first_submitted_qc>October 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>August 6, 2020</last_update_submitted>
  <last_update_submitted_qc>August 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cedars-Sinai Medical Center</investigator_affiliation>
    <investigator_full_name>Janet Wei</investigator_full_name>
    <investigator_title>Co-Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>magnetic resonance imaging</keyword>
  <keyword>positron emission tomography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Atherosclerosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT02265250
org study id: Pro00037025
nct id: NCT02265250
lead sponsor: 
has dmc: Yes
Cardiovascular disease (CVD) remains the leading cause of death in the United States, and
      improved CVD risk assessment is needed for personalized medicine. Atherosclerosis measures
      including plaque volume and adverse plaque features have prognostic value. Novel techniques
      have been developed for assessing carotid, coronary, and femoral atherosclerosis using
      magnetic resonance imaging (MRI) methods that are rapid and reproducible, have improved
      spatial resolution, and do not require contrast media, making atherosclerosis assessment in
      multiple vascular beds feasible during a single MRI session. This pilot research will provide
      preliminary data to develop an innovative global atherosclerosis measure including carotid,
      coronary, and femoral vascular beds, for assessing cardiovascular risk and for monitoring
      atherosclerosis response to therapy. 20 participants will be recruited in one year.
There are up to 2 study visits in this study.

      During the first visit, the investigators will obtain non-contrast MRI (carotid, coronary,
      and femoral) in 20 subjects with known coronary atherosclerosis but varying degrees of CVD
      risk.

        1. 5 asymptomatic subjects with lower CVD risk (recent coronary artery calcium score [CACS]
           10-299)

        2. 5 asymptomatic subjects with higher CVD risk (CACS 300-1000)

        3. 5 subjects with known coronary atherosclerosis and stable angina

        4. 5 subjects with known atherosclerosis and recent acute myocardial infarction

      The investigators will measure plaque volume and assess adverse plaque features (intra-plaque
      hemorrhage, positive remodeling, lesion eccentricity) in the three vascular beds.

      Eight of these subjects with evidence of large plaque burden by MRI will be asked to return
      for a simultaneous positron emission tomography (PET)-MRI imaging with 18F-sodium fluoride
      (18F-NaF) of their carotid, coronary, and femoral arteries, in which 18F-NaF uptake in plaque
      will represent micro-calcifications, which is associated with high-risk plaque.

      In all 20 subjects, the investigators will also measure the following biomarkers which have
      been shown to be useful for CVD risk assessment of atherosclerosis: LDL, HDL, lipoprotein(a),
      apolipoprotein B/A-1 ratio, hemoglobin A1c, adiponectin, and highly sensitive C-reactive
      protein. The investigators will also calculate their estimated 10-year and lifetime
      atherosclerotic CVD risk (American Heart Association), Framingham 10-year CVD risk, and
      Reynolds 10-year CVD risk scores.

      We aim to obtain the second scan within 3 months of the first visit; thus, the subjects will
      participate in the study for approximately 3 months.

      All the procedures are research-related. The research visit will take approximately 3 hours,
      and there will be maximum two visits. There are no collaborations with other sites.
observational model: Cohort
time perspective: Prospective
measure: Plaque Volume
time frame: 24 hours
description: Quantitative plaque measurement using MRI software (VesselMass)
measure: Adverse plaque features
time frame: 24 hours
description: Presence of positive remodeling, lesion eccentricity, and intraplaque hemorrhage of plaque, on MRI
measure: 18F-NaF PET uptake
time frame: 3-6 months
description: Measured as maximum tissue/background ratio (TBR), to assess for high-risk plaque
measure: Laboratory biomarkers
time frame: 24 hours
description: Measured as levels of LDL-C, HDL-C, lipoprotein(a), ApoB/ApoA-1 ratio, hemoglobin A1c, plasma adiponectin, hsCRP
measure: Clinical risk scores
time frame: 24 hours
description: Measured as (1) ACC/AHA 10-year and lifetime atherosclerotic CVD risk, (2) Framingham 10-year CVD risk, and (3) Reynolds Risk 10-year CVD risk
arm group label: Asymptomatic, CACS <300
description: 5 asymptomatic subjects with low CVD risk, defined as recent coronary artery calcium score (CACS) <300
Noncontrast MRI of the bilateral carotid, coronary, and superficial femoral arteries; Laboratory blood test (cardiovascular biomarkers)
arm group label: Asymptomatic, CACS ≥300
description: 5 asymptomatic subjects with increased CVD risk, defined as a recent coronary artery calcium score (CACS) ≥300
Noncontrast MRI of the bilateral carotid, coronary, and superficial femoral arteries; Laboratory blood test (cardiovascular biomarkers); Simultaneous 18F-NaF PET/MRI of the bilateral carotid, coronary, and superficial femoral arteries
arm group label: Stable angina
description: 5 subjects with stable angina and evidence of coronary atherosclerosis based on a recent invasive or CT coronary angiogram
Noncontrast MRI of the bilateral carotid, coronary, and superficial femoral arteries; Laboratory blood test (cardiovascular biomarkers); Simultaneous 18F-NaF PET/MRI of the bilateral carotid, coronary, and superficial femoral arteries
arm group label: Recent acute MI
description: 5 subjects with a recent acute myocardial infarction (within 1 month) and evidence of coronary atherosclerosis based on invasive or CT coronary angiogram
Noncontrast MRI of the bilateral carotid, coronary, and superficial femoral arteries; Laboratory blood test (cardiovascular biomarkers); Simultaneous 18F-NaF PET/MRI of the bilateral carotid, coronary, and superficial femoral arteries
intervention type: Other
intervention name: MRI
description: Noncontrast T1- and T2-weighted 3.0 T MRI of the bilateral carotid, coronary, and superficial femoral arteries
arm group label: Asymptomatic, CACS <300
arm group label: Asymptomatic, CACS ≥300
arm group label: Recent acute MI
arm group label: Stable angina
intervention type: Other
intervention name: PET/MRI
description: Simultaneous 18F-NaF PET/MRI of the bilateral carotid, coronary, and superficial femoral arteries
arm group label: Asymptomatic, CACS ≥300
arm group label: Recent acute MI
arm group label: Stable angina
intervention type: Other
intervention name: Laboratory blood test
description: Cardiovascular biomarkers
arm group label: Asymptomatic, CACS <300
arm group label: Asymptomatic, CACS ≥300
arm group label: Recent acute MI
arm group label: Stable angina
We will obtain fasting lipid and inflammatory biomarkers (LDL-C, HDL-C, lipoprotein(a),
      ApoB/ApoA-1 ratio, hemoglobin A1c, plasma adiponectin, hsCRP).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Janet Wei, MD
role: Principal Investigator
affiliation: Cedars-Sinai Medical Center
last name: Noel Bairey Merz, MD
role: Principal Investigator
affiliation: Cedars-Sinai Medical Center
last name: Denisse Barajas
phone: 310-423-9666
email: denisse.barajas@cshs.org
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Cedars-Sinai Medical Center
investigator full name: Janet Wei
investigator title: Co-Principal Investigator
mesh term: Cardiovascular Diseases
mesh term: Atherosclerosis
sharing ipd: Yes