PTSDEarly Phase 1NCT03279393
PPG Project 3 - PET/MRI of the Brain-hematopoiesis-atherosclerosis Axis in PTSD Patients
A Early Phase 1 study testing fluorodeoxyglucose (FDG)-PET/MRI in people with PTSD and Trauma, run by Zahi Fayad at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- What is being tested?
- fluorodeoxyglucose (FDG)-PET/MRI
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Nov 2017to 14 Feb 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- 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.
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Stress and Atherosclerotic Plaque Macrophages: A Systems Biology Approach - PET/MRI of the Brain-hematopoiesis-atherosclerosis Axis in PTSD Patients
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.
Read the 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:
- 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.
- Blood pressure: One blood pressure reading, taken in the dominant arm, will be performed per the American Heart Association recommendations.
- 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.
- Blood draw: approximately 3 tablespoons of blood will be drawn to evaluate clinical variables.
- Imaging at Mount Sinai or Massachusetts General Hospital: A Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI) scan
- Urine drug screen
- C-SSRS safety assessment
- Being tested
- fluorodeoxyglucose (FDG)-PET/MRI
- Keywords
- Post-Traumatic Stress Disorder, PTSD, trauma, stress, atherosclerosis, macrophage, plaque burden, vascular inflammation, atherosclerotic inflammation, PET/MRI, 18F-FDG-PET
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluorodeoxyglucose (FDG)-PET/MRIDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| PTSD Subjects | Active comparator | Not described Receives: Drug: fluorodeoxyglucose (FDG)-PET/MRI |
| Trauma Control Subjects | Active comparator | Not described Receives: Drug: fluorodeoxyglucose (FDG)-PET/MRI |
| Healthy Control Subjects | Placebo comparator | Not described Receives: Drug: fluorodeoxyglucose (FDG)-PET/MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atherosclerotic burden in PTSD using PET/MRI
The atherosclerosis burden as measured by 18F-FDG-PET/MRI
Measured: Day 1
Secondary outcomes (4)
Degree of brain fear circuit activation
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.
Measured: Day 1
Level of circulating HPSCs
Measured: Day 1
Level of circulating immune cells
Measured: Day 1
Level of soluble inflammation biomarkers
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start28 Nov 2017
- Primary completion14 Feb 2023
- Study completion14 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zahi Fayad
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)
- Responsible party
- Sponsor-investigator, Zahi Fayad, Icahn School of Medicine at Mount Sinai
- Investigators
- Zahi Fayad, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279393
- Sponsor's protocol ID
- GCO 15-0893 P3
- Other IDs
- 1P01HL131478
- Status last verified
- Apr 2023
- First submitted
- 8 Sep 2017
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Fuster V, Kovacic JC. Acute coronary syndromes: pathology, diagnosis, genetics, prevention, and treatment. Circ Res. 2014 Jun 6;114(12):1847-51. doi: 10.1161/CIRCRESAHA.114.302806. Epub 2014 May 13. No abstract available.
PubMed 24824094Fuster V, Stein B, Ambrose JA, Badimon L, Badimon JJ, Chesebro JH. Atherosclerotic plaque rupture and thrombosis. Evolving concepts. Circulation. 1990 Sep;82(3 Suppl):II47-59.
PubMed 2203564Hansson GK, Libby P. The immune response in atherosclerosis: a double-edged sword. Nat Rev Immunol. 2006 Jul;6(7):508-19. doi: 10.1038/nri1882. Epub 2006 Jun 16.
PubMed 16778830Heidt T, Sager HB, Courties G, Dutta P, Iwamoto Y, Zaltsman A, von Zur Muhlen C, Bode C, Fricchione GL, Denninger J, Lin CP, Vinegoni C, Libby P, Swirski FK, Weissleder R, Nahrendorf M. Chronic variable stress activates hematopoietic stem cells. Nat Med. 2014 Jul;20(7):754-758. doi: 10.1038/nm.3589. Epub 2014 Jun 22.
PubMed 24952646Brudey C, Park J, Wiaderkiewicz J, Kobayashi I, Mellman TA, Marvar PJ. Autonomic and inflammatory consequences of posttraumatic stress disorder and the link to cardiovascular disease. Am J Physiol Regul Integr Comp Physiol. 2015 Aug 15;309(4):R315-21. doi: 10.1152/ajpregu.00343.2014. Epub 2015 Jun 10.
PubMed 26062635Plantinga L, Bremner JD, Miller AH, Jones DP, Veledar E, Goldberg J, Vaccarino V. Association between posttraumatic stress disorder and inflammation: a twin study. Brain Behav Immun. 2013 May;30:125-32. doi: 10.1016/j.bbi.2013.01.081. Epub 2013 Feb 4.
PubMed 23379997Nahrendorf M, Swirski FK. Lifestyle effects on hematopoiesis and atherosclerosis. Circ Res. 2015 Feb 27;116(5):884-94. doi: 10.1161/CIRCRESAHA.116.303550.
PubMed 25722442Edmondson D, Kronish IM, Shaffer JA, Falzon L, Burg MM. Posttraumatic stress disorder and risk for coronary heart disease: a meta-analytic review. Am Heart J. 2013 Nov;166(5):806-14. doi: 10.1016/j.ahj.2013.07.031. Epub 2013 Sep 24.
PubMed 24176435Thakur GS, Daigle BJ Jr, Dean KR, Zhang Y, Rodriguez-Fernandez M, Hammamieh R, Yang R, Jett M, Palma J, Petzold LR, Doyle FJ 3rd. Systems biology approach to understanding post-traumatic stress disorder. Mol Biosyst. 2015 Apr;11(4):980-93. doi: 10.1039/c4mb00404c.
PubMed 25627823Graebe M, Borgwardt L, Hojgaard L, Sillesen H, Kjaer A. When to image carotid plaque inflammation with FDG PET/CT. Nucl Med Commun. 2010 Sep;31(9):773-9. doi: 10.1097/MNM.0b013e32833c365e.
PubMed 20543757Tawakol A, Fayad ZA, Mogg R, Alon A, Klimas MT, Dansky H, Subramanian SS, Abdelbaky A, Rudd JH, Farkouh ME, Nunes IO, Beals CR, Shankar SS. Intensification of statin therapy results in a rapid reduction in atherosclerotic inflammation: results of a multicenter fluorodeoxyglucose-positron emission tomography/computed tomography feasibility study. J Am Coll Cardiol. 2013 Sep 3;62(10):909-17. doi: 10.1016/j.jacc.2013.04.066. Epub 2013 May 30.
PubMed 23727083Calcagno C, Cornily JC, Hyafil F, Rudd JH, Briley-Saebo KC, Mani V, Goldschlager G, Machac J, Fuster V, Fayad ZA. Detection of neovessels in atherosclerotic plaques of rabbits using dynamic contrast enhanced MRI and 18F-FDG PET. Arterioscler Thromb Vasc Biol. 2008 Jul;28(7):1311-7. doi: 10.1161/ATVBAHA.108.166173. Epub 2008 May 8.
PubMed 18467641Hodes GE, Pfau ML, Leboeuf M, Golden SA, Christoffel DJ, Bregman D, Rebusi N, Heshmati M, Aleyasin H, Warren BL, Lebonte B, Horn S, Lapidus KA, Stelzhammer V, Wong EH, Bahn S, Krishnan V, Bolanos-Guzman CA, Murrough JW, Merad M, Russo SJ. Individual differences in the peripheral immune system promote resilience versus susceptibility to social stress. Proc Natl Acad Sci U S A. 2014 Nov 11;111(45):16136-41. doi: 10.1073/pnas.1415191111. Epub 2014 Oct 20.
PubMed 25331895Kim EJ, Kim S, Kang DO, Seo HS. Metabolic activity of the spleen and bone marrow in patients with acute myocardial infarction evaluated by 18f-fluorodeoxyglucose positron emission tomograpic imaging. Circ Cardiovasc Imaging. 2014 May;7(3):454-60. doi: 10.1161/CIRCIMAGING.113.001093. Epub 2014 Jan 31.
PubMed 24488982Shin LM, Lasko NB, Macklin ML, Karpf RD, Milad MR, Orr SP, Goetz JM, Fischman AJ, Rauch SL, Pitman RK. Resting metabolic activity in the cingulate cortex and vulnerability to posttraumatic stress disorder. Arch Gen Psychiatry. 2009 Oct;66(10):1099-107. doi: 10.1001/archgenpsychiatry.2009.138.
PubMed 19805700
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress and Atherosclerotic Plaque Macrophages: A Systems Biology Approach - PET/MRI of the Brain-hematopoiesis-atherosclerosis Axis in PTSD Patients
- ClinicalTrials.gov ID
- NCT03279393
- Acronym / sponsor ID
- GCO 15-0893 P3
- Keywords
- Post-Traumatic Stress Disorder, PTSD, trauma, stress, atherosclerosis, macrophage, plaque burden, vascular inflammation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Zahi FayadUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)
- Study start
- 28 Nov 2017 (actual)
- Primary completion
- 14 Feb 2023 (actual)
- Study completion
- 14 Feb 2023 (actual)
- First posted
- 12 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Blood pressure: One blood pressure reading, taken in the dominant arm, will be performed per the American Heart Association recommendations.
- 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.
- Blood draw: approximately 3 tablespoons of blood will be drawn to evaluate clinical variables.
- Imaging at Mount Sinai or Massachusetts General Hospital: A Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI) scan
- Urine drug screen
- C-SSRS safety assessment
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PTSD Subjects | Active comparator | Drug: fluorodeoxyglucose (FDG)-PET/MRI |
| Trauma Control Subjects | Active comparator | Drug: fluorodeoxyglucose (FDG)-PET/MRI |
| Healthy Control Subjects | Placebo comparator | Drug: fluorodeoxyglucose (FDG)-PET/MRI |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- 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);
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fluorodeoxyglucose (FDG)-PET/MRIInnovative 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) | Drug | Healthy Control Subjects, PTSD Subjects, Trauma Control Subjects |
Primary outcome
Atherosclerotic burden in PTSD using PET/MRI
Time frame: Day 1
The atherosclerosis burden as measured by 18F-FDG-PET/MRI
4 secondary outcomes
Degree of brain fear circuit activation
Time frame: Day 1
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Background: PubMed 24824094Fuster V, Kovacic JC. Acute coronary syndromes: pathology, diagnosis, genetics, prevention, and treatment. Circ Res. 2014 Jun 6;114(12):1847-51. doi: 10.1161/CIRCRESAHA.114.302806. Epub 2014 May 13. No abstract available.
- Background: PubMed 2203564Fuster V, Stein B, Ambrose JA, Badimon L, Badimon JJ, Chesebro JH. Atherosclerotic plaque rupture and thrombosis. Evolving concepts. Circulation. 1990 Sep;82(3 Suppl):II47-59.
- Background: PubMed 16778830Hansson GK, Libby P. The immune response in atherosclerosis: a double-edged sword. Nat Rev Immunol. 2006 Jul;6(7):508-19. doi: 10.1038/nri1882. Epub 2006 Jun 16.
- Background: PubMed 24952646Heidt T, Sager HB, Courties G, Dutta P, Iwamoto Y, Zaltsman A, von Zur Muhlen C, Bode C, Fricchione GL, Denninger J, Lin CP, Vinegoni C, Libby P, Swirski FK, Weissleder R, Nahrendorf M. Chronic variable stress activates hematopoietic stem cells. Nat Med. 2014 Jul;20(7):754-758. doi: 10.1038/nm.3589. Epub 2014 Jun 22.
- Background: PubMed 26062635Brudey C, Park J, Wiaderkiewicz J, Kobayashi I, Mellman TA, Marvar PJ. Autonomic and inflammatory consequences of posttraumatic stress disorder and the link to cardiovascular disease. Am J Physiol Regul Integr Comp Physiol. 2015 Aug 15;309(4):R315-21. doi: 10.1152/ajpregu.00343.2014. Epub 2015 Jun 10.
- Background: PubMed 23379997Plantinga L, Bremner JD, Miller AH, Jones DP, Veledar E, Goldberg J, Vaccarino V. Association between posttraumatic stress disorder and inflammation: a twin study. Brain Behav Immun. 2013 May;30:125-32. doi: 10.1016/j.bbi.2013.01.081. Epub 2013 Feb 4.
- Background: PubMed 25722442Nahrendorf M, Swirski FK. Lifestyle effects on hematopoiesis and atherosclerosis. Circ Res. 2015 Feb 27;116(5):884-94. doi: 10.1161/CIRCRESAHA.116.303550.
- Background: PubMed 24176435Edmondson D, Kronish IM, Shaffer JA, Falzon L, Burg MM. Posttraumatic stress disorder and risk for coronary heart disease: a meta-analytic review. Am Heart J. 2013 Nov;166(5):806-14. doi: 10.1016/j.ahj.2013.07.031. Epub 2013 Sep 24.
- Background: PubMed 25627823Thakur GS, Daigle BJ Jr, Dean KR, Zhang Y, Rodriguez-Fernandez M, Hammamieh R, Yang R, Jett M, Palma J, Petzold LR, Doyle FJ 3rd. Systems biology approach to understanding post-traumatic stress disorder. Mol Biosyst. 2015 Apr;11(4):980-93. doi: 10.1039/c4mb00404c.
- Background: PubMed 20543757Graebe M, Borgwardt L, Hojgaard L, Sillesen H, Kjaer A. When to image carotid plaque inflammation with FDG PET/CT. Nucl Med Commun. 2010 Sep;31(9):773-9. doi: 10.1097/MNM.0b013e32833c365e.
- Background: PubMed 23727083Tawakol A, Fayad ZA, Mogg R, Alon A, Klimas MT, Dansky H, Subramanian SS, Abdelbaky A, Rudd JH, Farkouh ME, Nunes IO, Beals CR, Shankar SS. Intensification of statin therapy results in a rapid reduction in atherosclerotic inflammation: results of a multicenter fluorodeoxyglucose-positron emission tomography/computed tomography feasibility study. J Am Coll Cardiol. 2013 Sep 3;62(10):909-17. doi: 10.1016/j.jacc.2013.04.066. Epub 2013 May 30.
- Background: PubMed 18467641Calcagno C, Cornily JC, Hyafil F, Rudd JH, Briley-Saebo KC, Mani V, Goldschlager G, Machac J, Fuster V, Fayad ZA. Detection of neovessels in atherosclerotic plaques of rabbits using dynamic contrast enhanced MRI and 18F-FDG PET. Arterioscler Thromb Vasc Biol. 2008 Jul;28(7):1311-7. doi: 10.1161/ATVBAHA.108.166173. Epub 2008 May 8.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zahi Fayad, PhD principal investigator
Icahn School of Medicine at Mount Sinai
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing fluorodeoxyglucose (FDG)-PET/MRI in people with PTSD and Trauma, run by Zahi Fayad at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atherosclerotic burden in PTSD using PET/MRI (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03279393, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.