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临床试验/NCT04298944
NCT04298944已完成不适用

AuRA Study: Association of Mood With Risk for Atherosclerosis

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2020年3月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
37
试验地点
1
主要终点
Arterial stiffness as assessed by Augmentation Index

研究概览

简要总结

The investigators will aim to determine the association of mood disorders (MDO) with preclinical and clinical cardiovascular (CVD) risk factors among children.

The investigators will also aim to identify traditional and non traditional predictors of CVD risk among children with MDO.

详细描述

This research is being done to determine if mood disorders in children have an impact on stiffness of arteries and/or cause the arteries to not work as well and if MDOs impact blood pressure over a 24 hour period of time.The investigators also want to determine if children with mood disorders have any risk factors or blood tests that can predict how stiff arteries are or how well arteries function and if these are associated with cardiovascular disease risk. The investigators also want to determine if children with mood disorders have greater adverse childhood experiences, worse emotional regulation and poorer quality of sleep. The investigators hope that information from this study could help in earlier detection of cardiovascular disease risk in children.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
— 至 22 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children Ages ≤ 22 years old
  • Enrolled in the CHAMPION Trial and have agreed to be contacted for future studies or children who visit PMP clinic and have MDO and a healthy weight or participants in the Be-HealthY Cohort whose data indicate no history of MDO.

排除标准

  • Not able to speak English
  • Unable to lie supine
  • Significant Arrhythmia
  • If participant has used vaso-active drugs the morning of the test (tobacco, caffeine decongestants, or asthma medications).

结局指标

主要结局

Arterial stiffness as assessed by Augmentation Index

时间窗: 1 day

The Augmentation Index (measured as a percentage) will be determined from a vascular assessment and data obtained during 24-hour ambulatory blood pressure monitoring. A greater Augmentation Index represents a stiffer, less compliant vessel.

Arterial stiffness as assessed by Pulse wave velocity

时间窗: 1 day

This will be determined from Pulse wave velocity (m/sec) done at the study visit

Arterial stiffness as assessed by Ambulatory Arterial Stiffness Index (AASI)

时间窗: 1 day

The Ambulatory Arterial Stiffness Index will be determined from data obtained from vascular measures and during 24-hour ambulatory blood pressure monitoring. Arterial stiffness increases as the regression slope approaches 0 and the AASI approaches 1.

Endothelial function as assessed by Laser Doppler flow perfusion

时间窗: 1 day

The percent change in mean blood flow will be determined from Laser Doppler flow perfusion measurements obtained using a heating protocol.

Mean Blood pressure (mmHg)

时间窗: 1 day

Mean daytime systolic blood pressure in millimeters of mercury (mmHg) will be determined from 24-hour blood pressure monitoring.

次要结局

  • Pediatric Adverse Childhood Events (ACEs) score(1 day)
  • Children's Emotion Management Scale (CEMS) score(1 day)
  • Behavior Assessment for Children (BASC) score(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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