PPG Project 3 - PET/MRI of the Brain-hematopoiesis-atherosclerosis Axis in PTSD Patients
Condition: PTSD; Trauma; Healthy
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Project 3 of the PPG grant "Stress and Atherosclerotic Plaque Macrophages A Systems Biology
      Approach," funded by the NHLBI, examines the relationship between psychosocial stress and
      atherosclerotic inflammation, cell proliferation and burden using novel PET/MRI. Individuals
      with post-traumatic stress disorder, trauma controls and healthy controls will be recruited
      into a two-center clinical study. The study team will use functional MRI to examine the
      relationship between activation of fear circuits in the brain and relate these data to
      hematopoietic system activation, and vascular inflammation measured by FDG-PET, and
      atherosclerotic burden measured by MRI.
    

Detailed description: 
      In Project 3, the study team will employ innovative PET combined with magnetic resonance
      imaging (PET/MRI) to simultaneously study the hematopoietic system, the artery wall, and the
      brain's fear system, which comprises the amygdala and anterior cingulate cortex (ACC), to
      elucidate the relationship between psychosocial stress and systemic
      inflammation/atherosclerosis in a two center clinical study looking at: I) individuals with
      PTSD, II) individuals without PTSD but with exposure to severe psychosocial trauma (Trauma
      Control), and III) matched volunteers with neither PTSD nor exposure to trauma (Healthy
      Control). Participants in the three study groups, recruited from urban settings in New York
      and Boston, will be group-matched by age, gender, and Framingham risk scores (FRS). The study
      team will recruit 80 subjects in each group and in Aim 1, investigate the relationship
      between PTSD and atherosclerotic inflammation and burden measured by PET/MRI. In Aim 2, the
      study team will examine the relationships between brain's fear circuit responsiveness to
      threat assessed by functional MRI (fMRI) and white matter integrity assessed by diffusion
      tensor imaging (DTI) and relate these data to hematopoietic system activation, and vascular
      inflammation measured by fluorodeoxyglucose (FDG)-PET and atherosclerotic burden measured by
      MRI.

      The following will occur during the imaging visit:

        1. Questionnaire: study staff will administer a standardized questionnaire to collect
           general information on age, gender, race, and current contact information. A PET/MRI
           pre-screening form will also be administered to confirm eligibility for the PET/MRI
           scan. This questionnaire is specific to the PET/MRI scan.

        2. Blood pressure: One blood pressure reading, taken in the dominant arm, will be performed
           per the American Heart Association recommendations.

        3. Anthropometrics: Body weight and height will be measured according to standard methods
           and body mass index will be calculated as an index for obesity. Waist circumference will
           also be measured.

        4. Blood draw: approximately 3 tablespoons of blood will be drawn to evaluate clinical
           variables.

        5. Imaging at Mount Sinai or Massachusetts General Hospital: A Positron Emission
           Tomography/Magnetic Resonance Imaging (PET/MRI) scan

        6. Urine drug screen

        7. C-SSRS safety assessment
    

Intervention name(s): fluorodeoxyglucose (FDG)-PET/MRI
Intervention type(s): Drug
Intervention description(s): Innovative PET combined with magnetic resonance imaging (PET/MRI) to simultaneously study the hematopoietic system, the artery wall, and the brain's fear system, which comprises the amygdala and anterior cingulate cortex (ACC)
Intervention MeSH terms: Fluorodeoxyglucose F18
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Post-Traumatic Stress Disorder; PTSD; trauma; stress; atherosclerosis; macrophage; plaque burden; vascular inflammation; atherosclerotic inflammation; PET/MRI; 18F-FDG-PET