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Key Dimensions of PTSD and ED

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ClinicalTrials.gov Identifier: NCT03778307
Recruitment Status : Recruiting
First Posted : December 19, 2018
Last Update Posted : July 13, 2021
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jennifer A. Sumner, PhD, University of California, Los Angeles

Brief Summary:
This study will test whether endothelial dysfunction could be the early subclinical mechanism by which posttraumatic stress disorder (PTSD) increases cardiovascular disease (CVD) risk, and whether posttraumatic fear-a key component of PTSD-or another PTSD dimension could be the target to offset that risk. The results of this study may help trauma-exposed individuals who are at risk of having CVD events.

Condition or disease Intervention/treatment
Trauma PTSD Endothelial Dysfunction Behavioral: Psychophysiological fear conditioning and extinction task Behavioral: Eyetracking task

Detailed Description:
Posttraumatic stress disorder (PTSD) increases risk of incident cardiovascular disease (CVD) by 25-50%. Most individuals (50-90%) experience a traumatic event in their lifetime, and PTSD is the fifth most common psychiatric disorder. Experts have now called for increased CVD surveillance after trauma and for PTSD treatment trials powered to reduce CVD risk. However, both CVD risk and PTSD are complex phenomena that likely interact in nuanced ways. This study will determine which PTSD dimension(s) contribute to endothelial dysfunction, one of the earliest modifiable precursors to CVD. The investigators will examine cross-sectional and longitudinal associations of PTSD and its underlying dimensions with functional and, secondarily, cellular measures of endothelial dysfunction (FMD and circulating endothelial cell-derived microparticles, respectively) in a community-dwelling sample of CVD-free adult men and women with a history of trauma (50% with current PTSD).

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Key Dimensions of Post-traumatic Stress Disorder (PTSD) and Endothelial Dysfunction (ED)
Actual Study Start Date : November 20, 2019
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Trauma exposed without PTSD
Individuals with a history of trauma exposure who do not have current PTSD
Behavioral: Psychophysiological fear conditioning and extinction task
Behavioral task to assess psychophysiological measures of fear

Behavioral: Eyetracking task
Behavioral task to assess dysphoria-relevant attention allocation

Trauma exposed with PTSD
Individuals with a history of trauma exposure and a current diagnosis of PTSD
Behavioral: Psychophysiological fear conditioning and extinction task
Behavioral task to assess psychophysiological measures of fear

Behavioral: Eyetracking task
Behavioral task to assess dysphoria-relevant attention allocation




Primary Outcome Measures :
  1. Flow-mediated dilation of the brachial artery (FMD) % [ Time Frame: Baseline ]
    FMD is the percent difference in diameter of the brachial artery, before and after occlusion. Impaired endothelial function occurs when blood vessels are unable to dilate fully in response to nitric oxide synthesis and release, which is manifested as impaired endothelium-dependent vasodilation (i.e., lower FMD). Lower FMD has been associated with the degree of coronary atherosclerosis and predicts CVD events.


Secondary Outcome Measures :
  1. Circulating EMPs expressing CD62E [ Time Frame: Baseline ]
    EMPs expressing CD62E (i.e., endothelial cell activation) and CD31 (i.e., endothelial cell apoptosis) will be measured. Assessments of circulating EMPs will be measured using flow cytometry, and total flow cytometry counts will be converted to the number of EMPs per uL of blood. Higher concentrations of EMPs expressing CD62E and CD31 indicate greater endothelial dysfunction.

  2. Circulating EMPs expressing CD31 [ Time Frame: Baseline ]
    EMPs expressing CD62E (i.e., endothelial cell activation) and CD31 (i.e., endothelial cell apoptosis) will be measured. Assessments of circulating EMPs will be measured using flow cytometry, and total flow cytometry counts will be converted to the number of EMPs per uL of blood. Higher concentrations of EMPs expressing CD62E and CD31 indicate greater endothelial dysfunction.


Biospecimen Retention:   Samples With DNA
Blood and urine samples for inflammatory and oxidative stress biomarkers; a blood sample for DNA collection is an optional aspect of this study


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Trauma-exposed adults without a history of cardiovascular disease recruited from the community
Criteria

Inclusion Criteria:

  • Aged 18+ years
  • History of exposure to a psychological trauma (e.g., natural disaster, physical assault)
  • Fluent in English
  • Willing to and capable of providing informed consent

Additional Inclusion Criteria for the PTSD Group

  • Diagnosed with current PTSD (duration of at least 1 month) using the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual 5th Edition (DSM-5) (CAPS-5) at the diagnostic interview assessment

Exclusion Criteria:

  • History of CVD (i.e., diagnosis of myocardial infarction, unstable angina, heart failure, peripheral artery disease, or stroke)
  • Deemed unable to comply with the protocol (either self-selected or by indicating during screening that could not complete all requested tasks)
  • Current bipolar disorder or psychotic disorder
  • Mild or more severe cognitive impairment [Mini-Mental State Exam (MMSE)3 score ≤18]
  • Current moderate or severe substance use disorder
  • Acute, unstable, or severe medical disorder or pregnancy
  • Deemed to need immediate psychiatric intervention (e.g., active suicidality)
  • Use of antipsychotic, mood stabilizer, antidepressant, or stimulant medication in the past 4 weeks
  • Daily benzodiazepine use in the past 2 weeks

Additional Exclusion Criteria for the Trauma-Exposed Matched Control Group

  • Current or past diagnosis of any DSM-5 psychiatric disorder
  • CAPS-5 total score ≥25

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): NCT03778307


Contacts
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Contact: Shiloh Cleveland, BA (310) 737-8279 scleveland@psych.ucla.edu

Locations
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United States, California
UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Shiloh Cleveland, BA       scleveland@psych.ucla.edu   
Contact: Jennifer A Sumner, PhD    (310) 794-9860    jsumner@psych.ucla.edu   
Principal Investigator: Jennifer A Sumner, PhD         
Sponsors and Collaborators
University of California, Los Angeles
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Jennifer A Sumner, PhD University of California, Los Angeles
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jennifer A. Sumner, PhD, Assistant Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03778307    
Other Study ID Numbers: AAAR8563
R01HL139614 ( U.S. NIH Grant/Contract )
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: July 13, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jennifer A. Sumner, PhD, University of California, Los Angeles:
Trauma
PTSD
Endothelial Dysfunction
Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders