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

ID#: NCT03279393

Age: 30 - 65 years

Gender: All

Healthy Subjects: Accepts Healthy Volunteers

Study Phase: Early Phase 1

Recruitment Status: Recruiting

Start Date: November 28, 2017

End Date: February 28, 2022

Contact Information:
Mallory Stellato, MPH
(212) 824-8492
Omar Alani, BS
(617) 798-0827
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.
Eligibility:

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 one year 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 one year 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 (not including ADD, ADHD)

- 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 at assessment day

- 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;

- Subjects with malignancies that are within 5 years of remission are excluded.

- Clinically significant abnormalities of laboratories or advanced systemic disease (i.e. malignancy); specific cutoffs include:

- A value of >52 for high-sensitivity troponin (however a value between 13 and 52 will need PI clearance); a threshold of .03 and .01 respectively, for older generation troponin

- Leukopenia: WBC <4.0

- HsCRP >10

- EGFR <60

- Known or active liver disease with AST/ALT >3 times the ULN, Bil >2 times the ULN

- Coagulation abnormalities such as INR >1.1, aPTT >34.9 (unless subject is on anticoagulation therapy)

- Type 1 diabetes

- Type 2 diabetes AND HbA1C > 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.
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