<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/NCT01724749</url>
  </required_header>
  <id_info>
    <org_study_id>s-20120056</org_study_id>
    <nct_id>NCT01724749</nct_id>
  </id_info>
  <brief_title>Cardiovascular Molecular Calcification Assessed by 18F-NaF PET CT</brief_title>
  <acronym>CAMONA</acronym>
  <official_title>Cardiovascular Molecular Calcification Assessed by 18F-NaF PET CT: The CAMONA Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Odense University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the CAMONA study is to demonstrate the feasibility of cardiovascular molecular&#xD;
      calcification (CMC) assessment by means of 18F-sodium-fluoride (18F-NaF) positron emission&#xD;
      tomography (PET) computed tomography (CT) in a prospective cohort of healthy control subjects&#xD;
      and subjects with cardiovascular disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Atherosclerosis associated cardiovascular disease (CVD) remains a significant cause of&#xD;
      morbidity and mortality. Asymptomatic individuals with a moderate to high-risk of developing&#xD;
      acute atherosclerotic cardiovascular events will benefit most from intensive evidence-based&#xD;
      medical interventions.&#xD;
&#xD;
      The traditional approach to identify patients with moderate to high-risk of CVD involves&#xD;
      quantifying the presence of CVD risk factors. Based on gender, age, smoking, systolic blood&#xD;
      pressure and cholesterol levels, risk stratification algorithms such as the Framingham Risk&#xD;
      Score (FRS) and the European SCORE system can predict the 10-year risk of cardiovascular&#xD;
      death.&#xD;
&#xD;
      However, these algorithms are associated with several limitations, including&#xD;
      misclassification of women and individuals with high levels of a single risk factor. The risk&#xD;
      is underestimated in these individuals. Therefore, these individuals are not eligible for&#xD;
      treatment by current criteria of CVD prevention guidelines. Several studies indicate that the&#xD;
      traditional risk score models leave room for improvement, as they work reasonably well for&#xD;
      populations, but remain suboptimal for individual subjects.&#xD;
&#xD;
      New risk parameters are discovered on a regular basis. One of these parameters is&#xD;
      cardiovascular molecular calcification (CMC). This entity can be detected and quantified by&#xD;
      18F-NaF PET CT. It has been hypothesized that CMC can be detected years, maybe even decades,&#xD;
      before coronary artery calcium scoring (CACS) can be detected by conventional imaging&#xD;
      modalities like multislice CT. Theoretically, this tool can detect patients at a very early&#xD;
      stage of the disease. Providing evidence-based treatment to these individuals can,&#xD;
      theoretically, improve the prevention of CVD. Before this hypothesises can be tested, the&#xD;
      feasibility of 18F-NaF PET CT has to be demonstrated in both healthy controls as well as in&#xD;
      subjects with cardiovascular disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">November 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>Standardized uptake value (SUV) of 18F-NaF</measure>
    <time_frame>Up to 7 days after the day of PET CT acquisition</time_frame>
    <description>The SUV is a validated semi-quantitative assessment of PET radiotracer uptake. The SUV of 18F-NaF will be determined in the aorta, carotid arteries, coronary arteries, iliac arteries and the femoral arteries.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Target to background ratio (TBR) of 18F-NaF</measure>
    <time_frame>Up to 7 days after the day of PET CT acquisition</time_frame>
    <description>The TBR is a validated semi-quantitative assessment of PET radiotracer uptake. The TBR of 18F-NaF will be determined in the aorta, carotid arteries, coronary arteries, iliac arteries and the femoral arteries.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Standardized uptake value (SUV) of 18F-Fluorodeoxyglucose (18F-FDG)</measure>
    <time_frame>Up to 7 days after the day of PET CT acquisition</time_frame>
    <description>The SUV is a validated semi-quantitative assessment of PET radiotracer uptake. The SUV of 18F-FDG will be determined in the aorta, carotid arteries, iliac arteries and the femoral arteries.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target to background ratio (TBR) of 18F-FDG</measure>
    <time_frame>Up to 7 days after the day of PET CT acquisition</time_frame>
    <description>The TBR is a validated semi-quantitative assessment of PET radiotracer uptake. The TBR of 18F-FDG will be determined in the aorta, carotid arteries, iliac arteries and the femoral arteries.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between the TBR of 18F-NaF/18F-FDG and traditional cardiovascular risk factors.</measure>
    <time_frame>The cardiovascular risk factors will be determined, on average, 1 hour before 18F-NaF / 18F-FDG injection; which ever comes first</time_frame>
    <description>The traditional cardiovascular risk factors consist of:&#xD;
Smoking, pack years;&#xD;
Alcohol, units/week;&#xD;
Blood pressure, mean arterial pressure, mmHg;&#xD;
Body mass index, kg/m2;&#xD;
Waist circumference, cm;&#xD;
History of cardiovascular disease;&#xD;
Family history of cardiovascular disease;&#xD;
Medication usage;&#xD;
Age;&#xD;
Gender.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between the TBR of 18F-NaF/18F-FDG and blood markers of atherosclerosis.</measure>
    <time_frame>The blood draw will be performed, on average, 1 hour before the 18F-FDG PET CT scan and the blood markers will determined in upto 48 hours after the 18F-FDG PET CT scan</time_frame>
    <description>Blood markers:&#xD;
Total cholesterol, mmol/L;&#xD;
LDL cholesterol, mmol/L;&#xD;
HDL cholesterol, mmol/L;&#xD;
Triglycerides, mmol/L;&#xD;
Homocysteine, mmol/L;&#xD;
Fasting plasma glucose, mmol/L;&#xD;
HBA1c, mmol/mol;&#xD;
High sensitivity C-reactive protein, nmol/L;&#xD;
Fibrinogen, umol/L;&#xD;
Leukocyte differentiation, cells/L;&#xD;
Creatinine, umol/L;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlations between 18F-NaF TBR, 18F-FDG TBR, and CT calcification scoring</measure>
    <time_frame>Up to 7 days after the day of PET CT acquisition</time_frame>
    <description>Correlation between the degree of 18F-NaF uptake, 18F-FDG uptake, CT-Calcification scoring and the various arterial segments (aorta, carotid arteries, iliac arteries and the femoral arteries.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target to background ratio (TBR) of 18F-NaF</measure>
    <time_frame>Up to 7 days after the day of PET CT acquisition</time_frame>
    <description>18F-NaF PET/CT images will be acquired at 45, 90 and 180 minutes after intravenous injection of the compound in a subset of 40 patients. The TBR of 18F-NaF will be determined at each time point and compared to allow determining the optimum tracer circulation time for maximum contrast between the vessel wall and blood pool.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target to background ratio (TBR) of 18F-FDG</measure>
    <time_frame>Up to 7 days after the day of PET CT acquisition</time_frame>
    <description>18F-FDG PET/CT images will be acquired at 90 and 180 minutes after intravenous injection of the compound in a subset of 40 patients. The TBR of 18F-NaF will be determined at both time points and compared to allow determining the optimum tracer circulation time for maximum contrast between the vessel wall and blood pool.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between 18F-NaF / 18F-FDG uptake and 18F-FDG uptake in the brain</measure>
    <time_frame>Up to 7 days after the day of PET CT acquisition</time_frame>
    <description>18F-FDG uptake in the brain will be quantified by calculating the mean and maximum partial-volume corrected SUV.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between 18F-NaF TBR and 18F-NaF TBR two years after the baseline scan.</measure>
    <time_frame>2 years</time_frame>
    <description>The TBR will be determined in various segments of the arterial tree.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between 18F-FDG TBR and 18F-FDG TBR two years after the baseline scan.</measure>
    <time_frame>2 years</time_frame>
    <description>The TBR will be determined in various segments of the arterial tree.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between the TBR of 18F-NaF/18F-FDG and HeartSCORE</measure>
    <time_frame>Up to 7 days after the day of PET CT acquisition</time_frame>
    <description>The HeartSCORE will be calculated according to the current HeartSCORE protocol for Denmark.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between the TBR of 18F-NaF/18F-FDG and Framingham Risk Score</measure>
    <time_frame>Up to 7 days after the day of PET CT acquisition</time_frame>
    <description>The Framingham Risk Score will be calculated according to the current recommendations by the Framingham Heart Study group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between 18F-NaF / 18F-FDG uptake and 18F-NaF / 18F-FDG uptake in the vertebral body</measure>
    <time_frame>Up to 7 days after the day of PET CT acquisition</time_frame>
    <description>18F-NaF uptake in the 1st, 3rd and 5th lumbar vertebral body will be quantified by calculating the mean and maximum partial-volume corrected SUV.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arterial Calcification Score</measure>
    <time_frame>Up to 7 days after the day of PET CT acquisition</time_frame>
    <description>Arterial Calcification Scoring will be determined in Agatston Units as well as in volumetric units in all segments of the arterial tree (coronary arteries, aorta, carotid arteries, iliac and femoral arteries.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">144</enrollment>
  <condition>Cardiovascular Disease</condition>
  <condition>Atherosclerosis</condition>
  <condition>Angina Pectoris</condition>
  <arm_group>
    <arm_group_label>Healthy control subjects</arm_group_label>
    <description>Age: 21 - 80 years&#xD;
No prior history or symptoms of cardiovascular disease&#xD;
The investigators aim to include equal numbers of females and males. Furthermore, the investigators aim to include patients in six different age strata: 21-30, 31-40, 41-50, 51-60, 61-70, 71-80.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subjects with cardiovascular disease</arm_group_label>
    <description>Age: 21 - 80 years&#xD;
HeartSCORE &gt; 0%&#xD;
Symptoms of angina pectoris&#xD;
The investigators aim to include equal numbers of females and males. Furthermore, the investigators aim to include patients in six different age strata: 21-30, 31-40, 41-50, 51-60, 61-70, 71-80. Also, the investigators aim to include patients in 3 strata of HeartSCORE risk: low risk (1-4%), mild risk (5-9%) and high risk (&gt; 9%)</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood, serum.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy control subjects will be recruited from a random sample of Danish citizens. To&#xD;
        secure timely inclusion of healthy controls, blood donors will be approached for inclusion&#xD;
        as well.&#xD;
&#xD;
        Subjects with symptoms suggesting angina pectoris will be recruited from the Department of&#xD;
        Cardiology, Odense University Hospital. Each patient referred for symptoms suggesting&#xD;
        angina pectoris and eligibility for a coronary artery calcium scoring (CACS) will be&#xD;
        eligible for inclusion in the investigators study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 21 - 80 years&#xD;
&#xD;
          -  Healthy controls: No prior history or symptoms of cardiovascular disease&#xD;
&#xD;
          -  Cardiology subjects: Eligibility for CACS due to symptoms suggesting angina pectoris.&#xD;
&#xD;
          -  Cardiology subjects: HeartSCORE &gt; 0%.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Extensive physical activity or extensive partying passed 24 hours&#xD;
&#xD;
          -  History of malignant neoplasms with past 5 years&#xD;
&#xD;
          -  Known immunodeficiencies&#xD;
&#xD;
          -  History of deep vein thrombosis or acute pulmonary embolism within the previous three&#xD;
             months&#xD;
&#xD;
          -  History of alcohol abuses, illicit drug use, or drug abuse, or significant mental&#xD;
             illness&#xD;
&#xD;
          -  Initiation of statin-therapy within 3 months prior to consideration of study enrolment&#xD;
&#xD;
          -  History of autoimmune disease, such as systemic lupus erythematosus, inflammatory&#xD;
             bowel disease, sarcoidosis, rheumatoid arthritis, or psoriasis.&#xD;
&#xD;
          -  Participation in any clinical trial of an investigational drug, device, or medical&#xD;
             procedure within 30 days prior to baseline of the study&#xD;
&#xD;
          -  Enrolment or planned enrolment in another clinical trial during the study period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Poul F Høilund-Carlsen, MD, DMSc</last_name>
    <role>Study Chair</role>
    <affiliation>Odense University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Björn A Blomberg, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Odense University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Poul F Høilund-Carlsen, MD, DMSc</last_name>
    <phone>0045 2521 5445</phone>
    <email>pfhc@ouh.regionsyddanmark.dk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Björn A Blomberg, MD, MSc</last_name>
    <phone>004551648696</phone>
    <email>Bjorn.Blomberg@ouh.regionsyddanmark.dk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Cardiology, Odense University Hospital</name>
      <address>
        <city>Odense</city>
        <state>Region Syddanmark</state>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Axel Diederichsen, MD</last_name>
      <email>Axel.Diederichsen@ouh.regionsyddanmark.dk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Department of Nuclear Medicine, Odense University Hospital</name>
      <address>
        <city>Odense</city>
        <state>Region Syddanmark</state>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Poul F Høilund-Carlsen, MD, DMSc</last_name>
      <email>pfhc@ouh.regionsyddanmark.dk</email>
    </contact>
    <investigator>
      <last_name>Björn A Blomberg, MD, MSc</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Anders Thomassen, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Malene Hildebrandt, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Søren Hess, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 6, 2012</study_first_submitted>
  <study_first_submitted_qc>November 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <last_update_submitted>November 7, 2012</last_update_submitted>
  <last_update_submitted_qc>November 7, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 12, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Odense University Hospital</investigator_affiliation>
    <investigator_full_name>Björn A Blomberg</investigator_full_name>
    <investigator_title>MD, MSc</investigator_title>
  </responsible_party>
  <keyword>Atherosclerosis</keyword>
  <keyword>Sodium-Fluoride</keyword>
  <keyword>18F-Sodium Fluoride</keyword>
  <keyword>18F-NaF</keyword>
  <keyword>fluorodeoxyglucose</keyword>
  <keyword>18F-FDG</keyword>
  <keyword>FDG</keyword>
  <keyword>Positron emission tomography</keyword>
  <keyword>PET</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>
    <mesh_term>Angina Pectoris</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/NCT01724749
org study id: s-20120056
nct id: NCT01724749
lead sponsor: 
has dmc: No
The purpose of the CAMONA study is to demonstrate the feasibility of cardiovascular molecular
      calcification (CMC) assessment by means of 18F-sodium-fluoride (18F-NaF) positron emission
      tomography (PET) computed tomography (CT) in a prospective cohort of healthy control subjects
      and subjects with cardiovascular disease.
Atherosclerosis associated cardiovascular disease (CVD) remains a significant cause of
      morbidity and mortality. Asymptomatic individuals with a moderate to high-risk of developing
      acute atherosclerotic cardiovascular events will benefit most from intensive evidence-based
      medical interventions.

      The traditional approach to identify patients with moderate to high-risk of CVD involves
      quantifying the presence of CVD risk factors. Based on gender, age, smoking, systolic blood
      pressure and cholesterol levels, risk stratification algorithms such as the Framingham Risk
      Score (FRS) and the European SCORE system can predict the 10-year risk of cardiovascular
      death.

      However, these algorithms are associated with several limitations, including
      misclassification of women and individuals with high levels of a single risk factor. The risk
      is underestimated in these individuals. Therefore, these individuals are not eligible for
      treatment by current criteria of CVD prevention guidelines. Several studies indicate that the
      traditional risk score models leave room for improvement, as they work reasonably well for
      populations, but remain suboptimal for individual subjects.

      New risk parameters are discovered on a regular basis. One of these parameters is
      cardiovascular molecular calcification (CMC). This entity can be detected and quantified by
      18F-NaF PET CT. It has been hypothesized that CMC can be detected years, maybe even decades,
      before coronary artery calcium scoring (CACS) can be detected by conventional imaging
      modalities like multislice CT. Theoretically, this tool can detect patients at a very early
      stage of the disease. Providing evidence-based treatment to these individuals can,
      theoretically, improve the prevention of CVD. Before this hypothesises can be tested, the
      feasibility of 18F-NaF PET CT has to be demonstrated in both healthy controls as well as in
      subjects with cardiovascular disease.
observational model: Cohort
time perspective: Prospective
measure: Standardized uptake value (SUV) of 18F-NaF
time frame: Up to 7 days after the day of PET CT acquisition
description: The SUV is a validated semi-quantitative assessment of PET radiotracer uptake. The SUV of 18F-NaF will be determined in the aorta, carotid arteries, coronary arteries, iliac arteries and the femoral arteries.
measure: Target to background ratio (TBR) of 18F-NaF
time frame: Up to 7 days after the day of PET CT acquisition
description: The TBR is a validated semi-quantitative assessment of PET radiotracer uptake. The TBR of 18F-NaF will be determined in the aorta, carotid arteries, coronary arteries, iliac arteries and the femoral arteries.
measure: Standardized uptake value (SUV) of 18F-Fluorodeoxyglucose (18F-FDG)
time frame: Up to 7 days after the day of PET CT acquisition
description: The SUV is a validated semi-quantitative assessment of PET radiotracer uptake. The SUV of 18F-FDG will be determined in the aorta, carotid arteries, iliac arteries and the femoral arteries.
measure: Target to background ratio (TBR) of 18F-FDG
time frame: Up to 7 days after the day of PET CT acquisition
description: The TBR is a validated semi-quantitative assessment of PET radiotracer uptake. The TBR of 18F-FDG will be determined in the aorta, carotid arteries, iliac arteries and the femoral arteries.
measure: Correlation between the TBR of 18F-NaF/18F-FDG and traditional cardiovascular risk factors.
time frame: The cardiovascular risk factors will be determined, on average, 1 hour before 18F-NaF / 18F-FDG injection; which ever comes first
description: The traditional cardiovascular risk factors consist of:
Smoking, pack years;
Alcohol, units/week;
Blood pressure, mean arterial pressure, mmHg;
Body mass index, kg/m2;
Waist circumference, cm;
History of cardiovascular disease;
Family history of cardiovascular disease;
Medication usage;
Age;
Gender.
measure: Correlation between the TBR of 18F-NaF/18F-FDG and blood markers of atherosclerosis.
time frame: The blood draw will be performed, on average, 1 hour before the 18F-FDG PET CT scan and the blood markers will determined in upto 48 hours after the 18F-FDG PET CT scan
description: Blood markers:
Total cholesterol, mmol/L;
LDL cholesterol, mmol/L;
HDL cholesterol, mmol/L;
Triglycerides, mmol/L;
Homocysteine, mmol/L;
Fasting plasma glucose, mmol/L;
HBA1c, mmol/mol;
High sensitivity C-reactive protein, nmol/L;
Fibrinogen, umol/L;
Leukocyte differentiation, cells/L;
Creatinine, umol/L;
measure: Correlations between 18F-NaF TBR, 18F-FDG TBR, and CT calcification scoring
time frame: Up to 7 days after the day of PET CT acquisition
description: Correlation between the degree of 18F-NaF uptake, 18F-FDG uptake, CT-Calcification scoring and the various arterial segments (aorta, carotid arteries, iliac arteries and the femoral arteries.
measure: Target to background ratio (TBR) of 18F-NaF
time frame: Up to 7 days after the day of PET CT acquisition
description: 18F-NaF PET/CT images will be acquired at 45, 90 and 180 minutes after intravenous injection of the compound in a subset of 40 patients. The TBR of 18F-NaF will be determined at each time point and compared to allow determining the optimum tracer circulation time for maximum contrast between the vessel wall and blood pool.
measure: Target to background ratio (TBR) of 18F-FDG
time frame: Up to 7 days after the day of PET CT acquisition
description: 18F-FDG PET/CT images will be acquired at 90 and 180 minutes after intravenous injection of the compound in a subset of 40 patients. The TBR of 18F-NaF will be determined at both time points and compared to allow determining the optimum tracer circulation time for maximum contrast between the vessel wall and blood pool.
measure: Correlation between 18F-NaF / 18F-FDG uptake and 18F-FDG uptake in the brain
time frame: Up to 7 days after the day of PET CT acquisition
description: 18F-FDG uptake in the brain will be quantified by calculating the mean and maximum partial-volume corrected SUV.
measure: Correlation between 18F-NaF TBR and 18F-NaF TBR two years after the baseline scan.
time frame: 2 years
description: The TBR will be determined in various segments of the arterial tree.
measure: Correlation between 18F-FDG TBR and 18F-FDG TBR two years after the baseline scan.
time frame: 2 years
description: The TBR will be determined in various segments of the arterial tree.
measure: Correlation between the TBR of 18F-NaF/18F-FDG and HeartSCORE
time frame: Up to 7 days after the day of PET CT acquisition
description: The HeartSCORE will be calculated according to the current HeartSCORE protocol for Denmark.
measure: Correlation between the TBR of 18F-NaF/18F-FDG and Framingham Risk Score
time frame: Up to 7 days after the day of PET CT acquisition
description: The Framingham Risk Score will be calculated according to the current recommendations by the Framingham Heart Study group
measure: Correlation between 18F-NaF / 18F-FDG uptake and 18F-NaF / 18F-FDG uptake in the vertebral body
time frame: Up to 7 days after the day of PET CT acquisition
description: 18F-NaF uptake in the 1st, 3rd and 5th lumbar vertebral body will be quantified by calculating the mean and maximum partial-volume corrected SUV.
measure: Arterial Calcification Score
time frame: Up to 7 days after the day of PET CT acquisition
description: Arterial Calcification Scoring will be determined in Agatston Units as well as in volumetric units in all segments of the arterial tree (coronary arteries, aorta, carotid arteries, iliac and femoral arteries.
arm group label: Healthy control subjects
description: Age: 21 - 80 years
No prior history or symptoms of cardiovascular disease
The investigators aim to include equal numbers of females and males. Furthermore, the investigators aim to include patients in six different age strata: 21-30, 31-40, 41-50, 51-60, 61-70, 71-80.
arm group label: Subjects with cardiovascular disease
description: Age: 21 - 80 years
HeartSCORE > 0%
Symptoms of angina pectoris
The investigators aim to include equal numbers of females and males. Furthermore, the investigators aim to include patients in six different age strata: 21-30, 31-40, 41-50, 51-60, 61-70, 71-80. Also, the investigators aim to include patients in 3 strata of HeartSCORE risk: low risk (1-4%), mild risk (5-9%) and high risk (> 9%)
Whole blood, serum.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Poul F Høilund-Carlsen, MD, DMSc
role: Study Chair
affiliation: Odense University Hospital
last name: Björn A Blomberg, MD, MSc
role: Principal Investigator
affiliation: Odense University Hospital
last name: Poul F Høilund-Carlsen, MD, DMSc
phone: 0045 2521 5445
email: pfhc@ouh.regionsyddanmark.dk
last name: Björn A Blomberg, MD, MSc
phone: 004551648696
email: Bjorn.Blomberg@ouh.regionsyddanmark.dk
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Odense University Hospital
investigator full name: Björn A Blomberg
investigator title: MD, MSc
mesh term: Cardiovascular Diseases
mesh term: Atherosclerosis
mesh term: Angina Pectoris