Use of EndoPAT for Measurements of Endothelial Dysfunction in HIV Infected Children and Healthy Controls
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- endothelial function, as measured by endoPAT, between HIV-infected youth and matched healthy controls
研究概览
简要总结
Our objective is to determine whether HIV infected youth have higher level of endothelial dysfunction, as measured by Peripheral Arterial Tonometry, when compared to age matched healthy controls. The investigators also aim to gather preliminary data on whether endothelial Peripheral Arterial Tonometry (endoPAT) measurements of endothelial dysfunction are independently associated with HIV and antiretroviral factors, and with markers of inflammation and traditional cardiovascular disease risk.
详细描述
Study Objectives and Hypothesis Our objective is to determine whether HIV infected youth have higher level of endothelial dysfunction, as measured by Peripheral Arterial Tonometry, when compared to age matched healthy controls. We also aim to gather preliminary data on whether endoPAT measurements of endothelial dysfunction are independently associated with HIV and antiretroviral factors, and with markers of inflammation and traditional cardiovascular disease risk.
Specific Aim 1:
To compare endothelial function, as measured by endoPAT, between HIV-infected youth and matched healthy controls.
Hypothesis: HIV infected youths will have impaired endothelial function compared to age matched healthy controls.
Specific Aim 2:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For HIV+ group:
- •age 8-30 years of age
- •HIV infection
- •On continuous ART for at least 6 months
- •HIV-1 RNA < 1,000 copies/mL performed in the past 5 months
- •For healthy controls:
- •age and gender matched 1:1 to HIV-positive subjects
- •absence of known HIV or other medical conditions that may affect systemic inflammation
- •Not receiving or prescribed any regular chronic medications.
排除标准
- •- Active illness or regular medication
- •Known coronary artery disease
- •Pregnancy and or lactation
结局指标
主要结局
endothelial function, as measured by endoPAT, between HIV-infected youth and matched healthy controls
时间窗: one year
Endothelial function will be measured using peripheral arterial tonometry. The device will record finger arterial pulsatile volume changes. The recordings will be performed with the patient in supine position with both hands at the same level. A blood pressure cuff will be placed on the upper arm (non-dominant); the probes will be placed on the finger of each hand (same finger on both hands) and continuing recording of blood volume responses from both hands will be initiated. After a period of stabilization, the blood pressure cuff on the study arm will be inflated to 60 mm Hg above systolic pressure for 5 min. The cuff will be deflated to induce reactive hyperemia and assess PAT. A reactive hyperemia index will be generated and is the post to pre occlusion PAT signal ratio in the occluded side normalized to the control side and corrected for baseline vascular tone. A normal index is \>1.67 and abnormal is ≤ 1.67.
risk factors of endothelial dysfunction
时间窗: one year
To determine risk factors of endothelial dysfunction by evaluating: 1) risk factors specific to HIV such as disease stage, CD4 count, HIV viral load, specific ART regimen, perinatally acquired versus behaviorally acquired infection; 2) markers of cardiovascular disease risk such as smoking, lipid levels, insulin resistance; 3) markers of inflammation and immune activation
endothelial function changes over a period of 24 weeks in HIV infected youths and controls.
时间窗: 1 year
次要结局
未报告次要终点
研究者
Grace McComsey
Grace McComsey, MD, FIDSA
University Hospitals Cleveland Medical Center