<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/NCT04505865</url>
  </required_header>
  <id_info>
    <org_study_id>2020A002750</org_study_id>
    <nct_id>NCT04505865</nct_id>
  </id_info>
  <brief_title>The Effect of Mindfulness on Vascular Inflammation in Stable Coronary Disease</brief_title>
  <official_title>The Effect of Mindfulness on Vascular Inflammation in Stable Coronary Disease: A Multi-System PET/MRI Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</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>
      This study aims to evaluate the effect of 8 weeks of a stress reduction intervention on&#xD;
      atherosclerotic plaque inflammation in adults with stable coronary artery disease, as&#xD;
      quantified by positron emission tomography (PET) with 18F-fluorodeoxyglucose (FDG) in&#xD;
      individuals with increased psychosocial stress.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This randomized controlled imaging study will be performed to evaluate the impact of&#xD;
      mindfulness-based stress reduction via a mind body program on arterial inflammation in&#xD;
      individuals with self-identified high levels of stress and stable coronary artery disease.&#xD;
      Individuals will undergo baseline FDG-PET and magnetic resonance imaging (MRI) and will then&#xD;
      be randomized to the stress-reduction intervention group or no intervention groups by blocks&#xD;
      (1:1) with stratification by age and sex. The stress reduction sessions focus on developing&#xD;
      an understanding of stress physiology and the physiology of the relaxation response, on&#xD;
      developing a regular practice of eliciting the relaxation response, and on learning cognitive&#xD;
      behavioral and positive psychology/resilience skills.&#xD;
&#xD;
      During the screening period, patient acceptability for the study will be assessed based on&#xD;
      medical history, concomitant medications, physical examination, and clinical laboratory test&#xD;
      results. Acceptability for study participation will be confirmed for subjects who identify as&#xD;
      having increased levels of stress and/or a Perceived Stress Scale (PSS) score &gt;=14. Once the&#xD;
      patient has passed screening, they will undergo baseline imaging followed by randomization&#xD;
      and group assignment. Approximately 12 weeks after randomization, all individuals will return&#xD;
      for follow-up imaging and evaluation.&#xD;
&#xD;
      FDG PET/MRI scans will be performed during the study for baseline and follow up to assess the&#xD;
      intervention's impact on the brain as well as systemic and arterial inflammation along with&#xD;
      other changes in related biomarker and imaging parameters. The Perceived Stress Scale will be&#xD;
      delivered prior imaging during both imaging visits to measure perceived psychological stress.&#xD;
      During both imaging sessions, subjects will be exposed to overt faces to measure signals&#xD;
      during brain imaging.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 1, 2021</start_date>
  <completion_date type="Anticipated">October 2026</completion_date>
  <primary_completion_date type="Anticipated">January 2026</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in arterial inflammation by PET imaging</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change in arterial inflammation measured as the ratio of tracer activity in the walls of the aorta and carotid arteries to the activity of background venous blood on FDG PET imaging (ratio without units) - from initial imaging to repeat imaging</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in brain activity by PET</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change in brain activity ratio of tracer activity in the amygdala (a stress-associated brain center) to the activity of background brain cortical tissue on FDG PET imaging (ratio without units) based on FDG PET - from initial imaging to repeat imaging</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in bone marrow activity by PET</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change in bone marrow activity measured in the vertebral bodies as a mean standardized uptake value (g/mL) based on FDG PET - from initial imaging to repeat imaging</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in inflammatory biomarkers</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change in high-sensitivity C-reactive protein (mg/L)- from initial imaging to repeat imaging</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">36</enrollment>
  <condition>Atherosclerosis</condition>
  <condition>Stress</condition>
  <condition>Inflammation</condition>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Optimally tolerated medical therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stress reduction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Optimally tolerated medical therapy and stress reduction course for 8 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Stress Reduction</intervention_name>
    <description>The stress reduction program is a multimodal mind-body resiliency program that incorporates 3 core components into each session:&#xD;
1) Elicitation of the Relaxation Response through mind-body techniques; 2) discussion about stress awareness to learn how to identify personal stressors and experiences of stress; and 3) coping strategies and adaptive perspective-taking to promote positive well-being.</description>
    <arm_group_label>Stress reduction</arm_group_label>
    <other_name>SMART-3RP</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must admit to feeling stressed and/or have PSS score &gt; 13 (moderate stress)&#xD;
&#xD;
          -  Must be willing to complete stress reduction course and imaging sessions with &lt; 3&#xD;
             missed appointments in last year&#xD;
&#xD;
          -  Known clinical cardiovascular disease with prior atherosclerotic myocardial&#xD;
             infarction, percutaneous intervention or bypass surgery &gt; 6 months before entry&#xD;
&#xD;
          -  Stable symptoms without symptomatic heart failure or arrhythmia or planned&#xD;
             revascularization&#xD;
&#xD;
          -  Maximally tolerated and stable medical regimen for 90 days that does not include a&#xD;
             high intensity statin for clinical reasons&#xD;
&#xD;
          -  No neurological disease or systemic inflammatory disease/current anti-inflammatory&#xD;
             therapy&#xD;
&#xD;
          -  No active psychiatric disease/medications or substance abuse (including tobacco&#xD;
             smoking or more than moderate alcohol) for last 6 months&#xD;
&#xD;
          -  No current participation in cardiac rehab or prior participation in stress reduction&#xD;
&#xD;
          -  For imaging: no pregnancy, weight &gt; 300 lbs., metal implants, uncontrolled&#xD;
             hyperglycemia, or inability to provide consent or comply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael T Osborne, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michael T Osborne, MD</last_name>
    <phone>6176432114</phone>
    <email>mosborne@mgh.harvard.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Osborne, MD</last_name>
      <email>mosborne@mgh.harvard.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>March 13, 2023</last_update_submitted>
  <last_update_submitted_qc>March 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Michael T. Osborne</investigator_full_name>
    <investigator_title>Instructor of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atherosclerosis</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Inflammation</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/NCT04505865
org study id: 2020A002750
nct id: NCT04505865
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to evaluate the effect of 8 weeks of a stress reduction intervention on
      atherosclerotic plaque inflammation in adults with stable coronary artery disease, as
      quantified by positron emission tomography (PET) with 18F-fluorodeoxyglucose (FDG) in
      individuals with increased psychosocial stress.
This randomized controlled imaging study will be performed to evaluate the impact of
      mindfulness-based stress reduction via a mind body program on arterial inflammation in
      individuals with self-identified high levels of stress and stable coronary artery disease.
      Individuals will undergo baseline FDG-PET and magnetic resonance imaging (MRI) and will then
      be randomized to the stress-reduction intervention group or no intervention groups by blocks
      (1:1) with stratification by age and sex. The stress reduction sessions focus on developing
      an understanding of stress physiology and the physiology of the relaxation response, on
      developing a regular practice of eliciting the relaxation response, and on learning cognitive
      behavioral and positive psychology/resilience skills.

      During the screening period, patient acceptability for the study will be assessed based on
      medical history, concomitant medications, physical examination, and clinical laboratory test
      results. Acceptability for study participation will be confirmed for subjects who identify as
      having increased levels of stress and/or a Perceived Stress Scale (PSS) score >=14. Once the
      patient has passed screening, they will undergo baseline imaging followed by randomization
      and group assignment. Approximately 12 weeks after randomization, all individuals will return
      for follow-up imaging and evaluation.

      FDG PET/MRI scans will be performed during the study for baseline and follow up to assess the
      intervention's impact on the brain as well as systemic and arterial inflammation along with
      other changes in related biomarker and imaging parameters. The Perceived Stress Scale will be
      delivered prior imaging during both imaging visits to measure perceived psychological stress.
      During both imaging sessions, subjects will be exposed to overt faces to measure signals
      during brain imaging.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in arterial inflammation by PET imaging
time frame: 12 weeks
description: Change in arterial inflammation measured as the ratio of tracer activity in the walls of the aorta and carotid arteries to the activity of background venous blood on FDG PET imaging (ratio without units) - from initial imaging to repeat imaging
measure: Change in brain activity by PET
time frame: 12 weeks
description: Change in brain activity ratio of tracer activity in the amygdala (a stress-associated brain center) to the activity of background brain cortical tissue on FDG PET imaging (ratio without units) based on FDG PET - from initial imaging to repeat imaging
measure: Change in bone marrow activity by PET
time frame: 12 weeks
description: Change in bone marrow activity measured in the vertebral bodies as a mean standardized uptake value (g/mL) based on FDG PET - from initial imaging to repeat imaging
measure: Change in inflammatory biomarkers
time frame: 12 weeks
description: Change in high-sensitivity C-reactive protein (mg/L)- from initial imaging to repeat imaging
arm group label: Usual care
arm group type: No Intervention
description: Optimally tolerated medical therapy
arm group label: Stress reduction
arm group type: Experimental
description: Optimally tolerated medical therapy and stress reduction course for 8 weeks
intervention type: Behavioral
intervention name: Stress Reduction
description: The stress reduction program is a multimodal mind-body resiliency program that incorporates 3 core components into each session:
1) Elicitation of the Relaxation Response through mind-body techniques; 2) discussion about stress awareness to learn how to identify personal stressors and experiences of stress; and 3) coping strategies and adaptive perspective-taking to promote positive well-being.
arm group label: Stress reduction
other name: SMART-3RP
criteria: 
gender: All
minimum age: 50 Years
maximum age: 65 Years
healthy volunteers: No
last name: Michael T Osborne, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
last name: Michael T Osborne, MD
phone: 6176432114
email: mosborne@mgh.harvard.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Michael T. Osborne
investigator title: Instructor of Medicine
mesh term: Atherosclerosis
mesh term: Coronary Disease
mesh term: Coronary Artery Disease
mesh term: Inflammation
sharing ipd: Yes