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PPG Project 3 - PET/MRI of the Brain-hematopoiesis-atherosclerosis Axis in PTSD Patients

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03279393
First Posted: September 12, 2017
Last Update Posted: September 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Massachusetts General Hospital
National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Zahi Fayad, Icahn School of Medicine at Mount Sinai
  Purpose
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.

Condition Intervention Phase
PTSD Trauma Healthy Drug: fluorodeoxyglucose (FDG)-PET/MRI Early Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Stress and Atherosclerotic Plaque Macrophages: A Systems Biology Approach - PET/MRI of the Brain-hematopoiesis-atherosclerosis Axis in PTSD Patients

Resource links provided by NLM:


Further study details as provided by Zahi Fayad, Icahn School of Medicine at Mount Sinai:

Primary Outcome Measures:
  • Atherosclerotic burden in PTSD using PET/MRI [ Time Frame: Day 1 ]
    The atherosclerosis burden as measured by 18F-FDG-PET/MRI


Secondary Outcome Measures:
  • Degree of brain fear circuit activation [ Time Frame: Day 1 ]
    The degree of brain fear circuit activation (both at rest and in response to validated stimuli) to be associated with activation of hematopoietic organs 18F-FDG PET imaging.

  • Level of circulating HPSCs [ Time Frame: Day 1 ]
  • Level of circulating immune cells [ Time Frame: Day 1 ]
  • Level of soluble inflammation biomarkers [ Time Frame: Day 1 ]

Estimated Enrollment: 240
Actual Study Start Date: March 17, 2017
Estimated Study Completion Date: February 28, 2022
Estimated Primary Completion Date: February 28, 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PTSD Subjects Drug: fluorodeoxyglucose (FDG)-PET/MRI
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)
Active Comparator: Trauma Control Subjects Drug: fluorodeoxyglucose (FDG)-PET/MRI
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)
Placebo Comparator: Healthy Control Subjects Drug: fluorodeoxyglucose (FDG)-PET/MRI
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)

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: A: Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI) scan
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Inclusion criteria for Group 1 (PTSD Subjects)

  • Male or female aged 30-65 years;
  • Meets DSM-V criteria for Post Traumatic Stress Disorder (PTSD) from at least three years prior to enrollment (as assessed using the SCID and the CAPS);
  • Participants must have a level of understanding of the English language sufficient to agree to all tests and examinations required by the study and must be able to participate fully in the informed consent process.

Inclusion for Group 2 (Trauma Control Subjects)

  • Male or female aged 30-65 years;
  • Meets DSM-V criteria A of Post Traumatic Stress Disorder (PTSD) from at least three years prior to enrollment, without satisfying criteria for a PTSD diagnoses according to the DSM-V (as assessed using the SCID);
  • Participants must have a level of understanding of the English language sufficient to agree to all tests and examinations required by the study and must be able to participate fully in the informed consent process.

Inclusion criteria for Group 3 (Healthy Control Subjects)

  • Male or female aged 30-65 years;
  • Does not meet for any current or past psychiatric diagnoses as defined by DSM-V criteria;
  • Participants must have a level of understanding of the English language sufficient to agree to all tests and examinations required by the study and must be able to participate fully in the informed consent process.

Exclusion Criteria:

  • Clinical history of atherosclerotic disease (prior myocardial infarction, stroke, peripheral artery disease)
  • Clinical history or presence of significant central nervous system and neurological diseases (e.g., TBI, multiple sclerosis)
  • History of class 3 or 4 heart failure, severe life-threatening arrhythmia (e.g., ventricular tachycardia) or severe mitral or aortic valvular disease
  • Current, primary psychiatric disorder other than PTSD,
  • History or current schizophrenia or primary psychotic disorders (e.g. schizophrenia, schizoaffective disorder)
  • Suicidal ideation with any intent or plan as measured by a Columbia Suicide Severity Rating Scale [C-SSRS] score of greater than 3 during the past month at the time of screening
  • Current or history of a major cognitive disorder or evidence of cognitive impairment as assessed by a score of the Mini Mental Status Exam (MMSE) of <24
  • Substance Use Disorder within the past 6 months;
  • Hypnotic medications used PRN are allowed except within 24 hours of the scan assessment day (V1)
  • Benzodiazepine medications used PRN (not to exceed 2 mg of lorazepam daily) are allowed except within 12 hours of the scan assessment day (V1)
  • Positive urine toxicology (u-tox) screening for illicit substances
  • Alcohol consumption above the NIAA cut-off for moderate alcohol intake (maximum 14 drinks for men and 7 drinks for women per week)
  • Concomitant use of high intensity statins (atorvastatin 40 mg/day; rosuvastatin > 20 mg/day; pitavastatin 2 mg/day)
  • Concomitant systemically-administered anti-inflammatory agents for chronic inflammatory conditions (e.g., methotrexate or anti-inflammatory biologics). On the other hand, NSAIDS, aspirin, and topical or inhaled steroids are permitted;
  • Chronic inflammatory conditions including but not limited to psoriasis and rheumatoid arthritis;
  • Clinically significant abnormalities of laboratories or advanced systemic disease (i.e. malignancy) 17. Uncontrolled diabetes within the past 6 months, as documented by an A1C > 7.5;
  • Women who are pregnant;
  • Any contraindications to MRI, including claustrophobia, any trauma or surgery which may have left magnetic material in the body, magnetic implants or pacemakers, and inability to lie still for 1 hour or more.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279393


Locations
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Zahi Fayad
Massachusetts General Hospital
National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)
Investigators
Principal Investigator: Zahi Fayad, PhD Icahn School of Medicine at Mount Sinai
  More Information

Publications:

Responsible Party: Zahi Fayad, Director of Translational and Molecular Imaging Institute, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03279393     History of Changes
Other Study ID Numbers: GCO 15-0893 P3
1P01HL131478 ( U.S. NIH Grant/Contract )
First Submitted: September 8, 2017
First Posted: September 12, 2017
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After each imaging visit, de-identified images of the subject will be transferred via a secure BrickFTP server to the Coordinating Center (Icahn School of Medicine at Mount Sinai) for storage and analysis.
URL: http://

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zahi Fayad, Icahn School of Medicine at Mount Sinai:
Post-Traumatic Stress Disorder
PTSD
trauma
stress
atherosclerosis
macrophage
plaque burden
vascular inflammation
atherosclerotic inflammation
PET/MRI
18F-FDG-PET

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action