Status:
COMPLETED
PPG Project 3 - PET/MRI of the Brain-hematopoiesis-atherosclerosis Axis in PTSD Patients
Lead Sponsor:
Zahi Fayad
Collaborating Sponsors:
Massachusetts General Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
PTSD
Trauma
Eligibility:
All Genders
30-65 years
Phase:
EARLY_PHASE1
Brief 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 in...
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 syste...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2023
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT03279393
Start Date
November 28 2017
End Date
February 14 2023
Last Update
April 14 2023
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029