<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/NCT03776682</url>
  </required_header>
  <id_info>
    <org_study_id>17-009867</org_study_id>
    <nct_id>NCT03776682</nct_id>
  </id_info>
  <brief_title>Myocardial Inflammation in Rheumatoid Arthritis: A Descriptive Study</brief_title>
  <official_title>Myocardial Inflammation in Rheumatoid Arthritis: A Descriptive Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rheumatoid arthritis (RA) patients have a higher prevalence of subclinical atherosclerosis&#xD;
      than the general population. In addition, RA patients experience higher rates of heart&#xD;
      failure with preserved ejection fraction (HFpEF). There is evidence that myocardial mechanics&#xD;
      and left ventricular diastolic function are more abnormal in the RA population and these&#xD;
      changes occur earlier than in the general population. Recently a study suggested that RA&#xD;
      patient have abnormal myocardial inflammation during a disease flare and that this is&#xD;
      improved with anti-inflammatory treatment. This study is aimed at describing the prevalence&#xD;
      of myocardial inflammation in patients during active RA disease flares and comparing that&#xD;
      with RA patients who are in remission. Investigators hope to show that abnormalities in&#xD;
      myocardial inflammation on PET imaging correlate with abnormalities in myocardial strain on&#xD;
      echocardiography. Coronary CT will be performed to establish the presence of subclinical&#xD;
      atherosclerosis and whether its presence affects changes in either myocardial inflammation or&#xD;
      myocardial strain. The hypothesis is that patients with evidence of myocardial inflammation&#xD;
      during the course of their RA disease are more likely to develop HFpEF during their lifetime.&#xD;
      Although the present study will not be of a duration to assess outcome, it will provide&#xD;
      descriptive data which may help guide future prospective study of patients with RA which may&#xD;
      help guide appropriate cardiovascular testing in this high risk population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 22, 2018</start_date>
  <completion_date type="Actual">May 26, 2023</completion_date>
  <primary_completion_date type="Actual">May 26, 2023</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>Subclinical myocardial inflammatory burden as detected by PET imaging</measure>
    <time_frame>14 days</time_frame>
    <description>To determine if myocardial F-18 fluorodeoxyglucose (FDG) positron emission tomography (PET) imaging in patients with rheumatoid arthritis reveals evidence of subclinical myocardial inflammation which correlate with level of systemic inflammatory burden.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Relationship of presence of myocardial inflammation to atherosclerotic burden</measure>
    <time_frame>7 days</time_frame>
    <description>To determine if mild to moderate atherosclerotic plaque burden on coronary computed tomographic angiography (CCTA) correlates with the degree of myocardial inflammation as assessed by FDG PET.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">35</enrollment>
  <condition>Myocardial Inflammation</condition>
  <condition>Rheumatoid Arthritis</condition>
  <condition>Coronary Artery Disease</condition>
  <condition>Myocardial Strain</condition>
  <arm_group>
    <arm_group_label>Acute inflammation</arm_group_label>
    <description>Patients with RA and active inflammation (by exam or inflammatory markers)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chronic remission</arm_group_label>
    <description>Patients with RA who are in remission (clinically)</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood is being stored for later biomarker assessment&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will consist of 40 Patients with the diagnosis of RA, according to&#xD;
        2010 ACR classification, who are referred to the Mayo Clinic Department of Rheumatology&#xD;
        outpatient clinic.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Diagnosis of Rheumatoid Arthritis according to 2010 American College of Rheumatology&#xD;
             (ACR) criteria (14)&#xD;
&#xD;
          -  RA disease duration ≤ 10 years since diagnosis&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Known clinical atherosclerotic disease (myocardial infarction, severe obstruction CAD&#xD;
             (≥ 1 untreated stenosis (≥ 70% in a major vessel) known by either invasive or&#xD;
             noninvasive testing), prior coronary artery intervention, prior coronary artery bypass&#xD;
             surgery, cerebrovascular event, peripheral vascular disease).&#xD;
&#xD;
          -  Prednisone &gt;10mg per day (or equivalent corticosteroid dose per day within last week)&#xD;
&#xD;
          -  Irregular heart rhythm (arrhythmia or cardiac conduction abnormality (e.g. atrial&#xD;
             fibrillation or flutter, frequent extrasystole, LBBB)&#xD;
&#xD;
          -  Relevant valvular heart disease (&gt; moderate regurgitation or stenosis of any heart&#xD;
             valve)&#xD;
&#xD;
          -  Clinical occurrence of heart failure with or without preserved ejection fraction&#xD;
&#xD;
          -  Impaired imaging quality or other contraindications for myocardial strain imaging&#xD;
&#xD;
          -  Relevant lung disease (including severe COPD with oxygen dependence, fibrosis,&#xD;
             symptomatic pleural effusion, oxygen dependence)&#xD;
&#xD;
          -  Sarcoidosis&#xD;
&#xD;
          -  Diabetes mellitus treated with insulin&#xD;
&#xD;
          -  estimated glomerular filtration rate (eGFR) &lt; 40ml/min&#xD;
&#xD;
          -  Known cancer&#xD;
&#xD;
          -  History of any-type of cardiomyopathy (e.g. cardiac amyloidosis, hypertrophic&#xD;
             cardiomyopathy,...)&#xD;
&#xD;
          -  Ejection fraction (EF) less than 45%&#xD;
&#xD;
          -  Life expectancy &lt; 1 year&#xD;
&#xD;
          -  BMI &gt;40kg/m2&#xD;
&#xD;
          -  Severe claustrophobia&#xD;
&#xD;
          -  Any known allergic reactions to intravenous contrast&#xD;
&#xD;
          -  Inability to receive beta blocker therapy or IV nitrates&#xD;
&#xD;
          -  Pregnant/ Breastfeeding women&#xD;
&#xD;
          -  Vulnerable persons due to Helsinki Declaration&#xD;
&#xD;
          -  Unable to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rekha Mankad, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>July 7, 2023</last_update_submitted>
  <last_update_submitted_qc>July 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Rekha Mankad</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocarditis</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03776682
org study id: 17-009867
nct id: NCT03776682
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Rheumatoid arthritis (RA) patients have a higher prevalence of subclinical atherosclerosis
      than the general population. In addition, RA patients experience higher rates of heart
      failure with preserved ejection fraction (HFpEF). There is evidence that myocardial mechanics
      and left ventricular diastolic function are more abnormal in the RA population and these
      changes occur earlier than in the general population. Recently a study suggested that RA
      patient have abnormal myocardial inflammation during a disease flare and that this is
      improved with anti-inflammatory treatment. This study is aimed at describing the prevalence
      of myocardial inflammation in patients during active RA disease flares and comparing that
      with RA patients who are in remission. Investigators hope to show that abnormalities in
      myocardial inflammation on PET imaging correlate with abnormalities in myocardial strain on
      echocardiography. Coronary CT will be performed to establish the presence of subclinical
      atherosclerosis and whether its presence affects changes in either myocardial inflammation or
      myocardial strain. The hypothesis is that patients with evidence of myocardial inflammation
      during the course of their RA disease are more likely to develop HFpEF during their lifetime.
      Although the present study will not be of a duration to assess outcome, it will provide
      descriptive data which may help guide future prospective study of patients with RA which may
      help guide appropriate cardiovascular testing in this high risk population.
observational model: Cohort
time perspective: Prospective
measure: Subclinical myocardial inflammatory burden as detected by PET imaging
time frame: 14 days
description: To determine if myocardial F-18 fluorodeoxyglucose (FDG) positron emission tomography (PET) imaging in patients with rheumatoid arthritis reveals evidence of subclinical myocardial inflammation which correlate with level of systemic inflammatory burden.
measure: Relationship of presence of myocardial inflammation to atherosclerotic burden
time frame: 7 days
description: To determine if mild to moderate atherosclerotic plaque burden on coronary computed tomographic angiography (CCTA) correlates with the degree of myocardial inflammation as assessed by FDG PET.
arm group label: Acute inflammation
description: Patients with RA and active inflammation (by exam or inflammatory markers)
arm group label: Chronic remission
description: Patients with RA who are in remission (clinically)
Blood is being stored for later biomarker assessment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Rekha Mankad, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Rekha Mankad
investigator title: Principal Investigator
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Coronary Artery Disease
mesh term: Myocarditis
mesh term: Inflammation
sharing ipd: No