Key Dimensions of Post-traumatic Stress Disorder (PTSD) and Endothelial Dysfunction (ED)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Flow-mediated dilation of the brachial artery (FMD) %
研究概览
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
- •Current or past diagnosis of any DSM-5 psychiatric disorder
- •CAPS-5 total score ≥25
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 (Behavioral)
Trauma exposed with PTSD
Individuals with a history of trauma exposure and a current diagnosis of PTSD
干预措施: Eyetracking task (Behavioral)
Trauma exposed without PTSD
Individuals with a history of trauma exposure who do not have current PTSD
干预措施: Eyetracking task (Behavioral)
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 (Behavioral)
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.
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)
- Circulating Endothelial Cell-derived Microparticles (EMPs) Expressing CD62E(Baseline)
- Circulating Endothelial Cell-derived Microparticles (EMPs) Expressing CD31(Baseline)
研究者
Jennifer A. Sumner, PhD
Assistant Professor
University of California, Los Angeles