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临床试验/NCT06557707
NCT06557707已完成不适用

Cardiovascular Health & Early Stress

Virginia Commonwealth University3 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2022年1月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
71
试验地点
3
主要终点
Cardiac Function

研究概览

简要总结

Childhood adversity is highly prevalent, with 59% of the U.S. population reporting at least one adverse childhood experience (ACE). Substantial evidence links childhood adversity to cardiometabolic disease later in the life course, including heart disease, diabetes, and stroke, which are 3 of the top 10 causes of mortality in the United States.

ACEs encompass many possible traumatic and distressing experiences, including abuse, neglect, or severe household dysfunctions. It is not surprising that the experience of those extreme events during the first decade of life has tremendous implications for the individual's psychological and physical health.

详细描述

Current knowledge supports that ACEs trigger emotional stress, anxiety, fear, and discomfort in the individual. Acute and intense mental stress leads to structural changes in the amygdala, prolonged activation of the hypothalamic-pituitary-adrenal axis, and hyperactivation of the sympathetic nervous system. Then, the body secretes hormones to activate the cardiovascular system to cope with stress with a rapid increase in arterial pressure and heart rate. If the trauma is severe and/or repeated, the resting state for heart rate and blood pressure are readjusted, resulting in these children living in a heightened physiological state of arousal, including higher heart and respiration rates. This status leads to endothelial dysfunction and atherothrombotic activation that can contribute to premature cardiovascular dysfunctions. Notably, there is evidence of a cumulative effect, or dose-response relationship, between the number of reported ACEs and the prevalence of health risk behaviors and chronic diseases. Thus, despite the prevalence of ACEs and the impact on health and society, the mechanisms underlying these dysfunctions are still poorly understood. The present study aims to understand the impact of different types of ACEs on cardiovascular health.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
9 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Men and pre-menopausal women
  • 18-30 years old
  • males and females
  • 9-17 years old

排除标准

  • Evidence of cardiovascular, pulmonary, renal, hepatic or cerebral diseases
  • Evidence of pregnancy or currently nursing.
  • Having a history of chronic pain
  • Having a history of rheumatoid arthritis
  • Evidence of cardiovascular, pulmonary, renal, hepatic or cerebral diseases
  • Evidence of pregnancy or currently nursing.
  • Having a history of chronic pain
  • Having a history of rheumatoid arthritis

研究组 & 干预措施

Young individuals ACE (ages 18-30 years old)

Young individuals who experienced accumulative adverse childhood experiences

干预措施: Childhood stress (Other)

Children ACE (ages 9-17 years old)

Children who experienced accumulative adverse childhood experiences .

干预措施: Childhood stress (Other)

Young individuals No ACE (ages 18-30 years old)

Young individuals who have not experienced accumulative adverse childhood experiences

Children No ACE (ages 9-17 years old)

Children who have not experienced accumulative adverse childhood experiences.

结局指标

主要结局

Cardiac Function

时间窗: Baseline

An evaluation of cardiac response will be monitored non-invasively. We will use ultrasound to visualize the heart and the blood vessels.

Cardiac MRI (CMR)

时间窗: Baseline

Cardiac MRI will be completed to monitor early signs of poor functionality.

Vascular function

时间窗: Baseline

This test examines how the blood vessels respond to different challenges and expand. It is used to characterize the cardiovascular health of the subject's blood vessels. Different events and substances will be used (under an IND) to test how the blood vessels react. The test is completed using Laser Doppler Speckle Contrast. We will measure how much the blood vessels dilate. Greater dilation, better vascular function.

次要结局

  • Lung Diffusing Capacity(Baseline)
  • HbA1c(Baseline)
  • Questionnaires(Baseline)
  • Spirometry(Baseline)
  • Arterial Stiffness(Baseline)
  • C-Reactive protein(Baseline)
  • Complete blood count(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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