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Completed

NCT Number: NCT03778307

Key Dimensions of PTSD and ED

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.

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Key information

Conditions

Trauma Endothelial Dysfunction Mental Disorders PTSD Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UCLA

Los Angeles, California, 90095, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychophysiological fear conditioning and extinction task

Behavioral

Behavioral task to assess psychophysiological measures of fear

Eyetracking task

Behavioral

Behavioral task to assess dysphoria-relevant attention allocation

Primary outcomes

  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 outcomes

  1. Circulating Endothelial Cell-derived Microparticles (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 Endothelial Cell-derived Microparticles (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.

Other outcomes

  1. Fear Load Based on Fear-potentiated Startle During Early Extinction

    Time frame: Baseline

    Fear-potentiated startle (FPS) to the danger cue (CS+) during early extinction as part of a fear acquisition and extinction paradigm; this measure reflects expression of conditioned fear during early extinction. FPS is measured through corrugator and orbicularis electromyography (EMG). Startle magnitude is assessed as the peak amplitude (in microVolts) of EMG contraction 20-200ms following the startle probe. A difference score for FPS is calculated by subtracting the startle magnitude to the noise alone probe from the startle magnitude to the CS to account for individual differences in startle magnitude and habituation. Higher values of this FPS difference score indicate greater fear load (i.e., greater overexpression of conditioned fear to a now safe signal during early extinction), which has been associated with PTSD.

  2. Averaged Total Dwell Time for Happy Faces

    Time frame: Baseline

    Averaged total dwell time of the happy faces Area of Interest (AOI) across 60 face matrices; reflects continuous gaze allocation to happy stimuli

  3. Averaged Total Dwell Time for Sad Faces

    Time frame: Baseline

    Averaged total dwell time of the sad faces Area of Interest (AOI) across 60 face matrices; reflects continuous gaze allocation to sad stimuli

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Key Dimensions of Post-traumatic Stress Disorder (PTSD) and Endothelial Dysfunction (ED)

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Dec 19, 2018
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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