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临床试验/NCT03778307
NCT03778307
已完成
不适用

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

University of California, Los Angeles1 个研究点 分布在 1 个国家目标入组 168 人2019年11月20日

概览

阶段
不适用
干预措施
Psychophysiological fear conditioning and extinction task
疾病 / 适应症
Trauma
发起方
University of California, Los Angeles
入组人数
168
试验地点
1
主要终点
Flow-mediated dilation of the brachial artery (FMD) %
状态
已完成
最后更新
3个月前

概览

简要总结

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.

详细描述

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).

注册库
clinicaltrials.gov
开始日期
2019年11月20日
结束日期
2025年6月30日
最后更新
3个月前
研究类型
Observational
性别
All

研究者

责任方
Principal Investigator
主要研究者

Jennifer A. Sumner, PhD

Assistant Professor

University of California, Los Angeles

入排标准

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Trauma exposed without PTSD

Individuals with a history of trauma exposure who do not have current PTSD

干预措施: Psychophysiological fear conditioning and extinction task

Trauma exposed without PTSD

Individuals with a history of trauma exposure who do not have current PTSD

干预措施: Eyetracking task

Trauma exposed with PTSD

Individuals with a history of trauma exposure and a current diagnosis of PTSD

干预措施: Psychophysiological fear conditioning and extinction task

Trauma exposed with PTSD

Individuals with a history of trauma exposure and a current diagnosis of PTSD

干预措施: Eyetracking task

结局指标

主要结局

Flow-mediated dilation of the brachial artery (FMD) %

时间窗: 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.

次要结局

  • Circulating EMPs expressing CD62E(Baseline)
  • Circulating EMPs expressing CD31(Baseline)

研究点 (1)

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