Acute and Long-term Effects of E-Cigarette Aerosol Inhalation on Biomarkers of Endothelial Function and Vascular Reactivity
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Inflammatory Blood-Based Biomarkers
研究概览
简要总结
This study comprises a portion of a larger study designed to compare results of vascular function in non-smokers to vascular function in healthy smokers chronically exposed to nicotinized electronic cigarette aerosol versus conventional cigarettes.
详细描述
Here, we 1) investigate the acute effects of non-nicotinized e-cigarette aerosol inhalation in nonsmokers in terms of blood-based markers of inflammation and oxidative stress, and 2) evaluate their association with hemodynamic-metabolic MRI parameters quantifying peripheral vascular reactivity, cerebrovascular reactivity, and aortic stiffness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI of 18.5 - 30
排除标准
- •Mental illness
- •Overt cardio- or neurovascular disease (prior heart attack, stroke, transient ischemic attacks)
- •Serious arrhythmias
- •Bronchospastic disease
- •Upper respiratory tract infection within the past six weeks
- •Chronic medication or antibiotics
- •Claustrophobia / contraindications for MRI
研究组 & 干预措施
Healthy, Non-Smokers
Non-nicotinized electronic cigarette aerosol (16 2-second long puffs)
干预措施: Electronic Cigarette Aerosol (Drug)
结局指标
主要结局
Inflammatory Blood-Based Biomarkers
时间窗: Participant blood draws occurred at two time points: 1) pre-vaping, 2) 120 minutes post-vaping. Inflammation index is calculated from the fold change in biomarker values over pre-vaping values
Post-vaping inflammation monitored by changes in an integrated cluster of blood-based biomarkers from serum/plasma of non-smoking healthy participants quantified at 0 and 120 min post-inhalation. The cluster consisted of: CRP, sICAM-1 in serum and HMGB1, ASC in plasma assayed using ELISA and quantified using absorbance-concentration curves generated by the manufacturers' standards; nitric oxide metabolites (nitrate + nitrite, NOx) in serum assayed with a nitrate/nitrite kit using a colorimetric standard provided by the manufacturer; reactive oxygen species (ROS) was quantified by using immortalized human pulmonary microvascular endothelial cells plated, prepared with serum, labeled with ROS dye and imaged confocal fluorescence microscopy. The outcome measure was expressed as fold increase over pre-vaping values.
Change in Overshoot Post-Vaping
时间窗: Overshoot was calculated at two time points: 1) pre-vaping, and 2) 40 minutes post-vaping.
Degree of overcompensatory effect post-vaping in the supply of oxygen after ischemia.
Change in Washout Time Post-Vaping
时间窗: Washout time calculation occurred at two time points: 1) pre-vaping, and 2) 40 minutes post-vaping
Transit time of desaturated capillary blood from tissue to the imaging location after e-cigarette vaping
Change in Upslope Post-Vaping
时间窗: Upslope was calculated at two time points: 1) pre-vaping, and 2) 40 minutes post-vaping
Tissue oxygen resaturation rate after e-cigarette vaping.
Acute Change in Aortic Pulse Wave Velocity Post-vaping
时间窗: PWV calculation occurred at two time points: 1) pre-vaping, 2) Fifteen minutes post-vaping.
Central arterial stiffness was assessed using aortic pulse-wave velocity (PWV), a biomarker of aortic stiffness calculated by measuring the velocity of a pulse wave between two points in the same artery. A higher aortic pulse wave velocity equates to a stiffer aorta. In each participant, aortic PWV was quantified, pre- and post-vaping, by dividing the path length of the aortic arch determined from a oblique sagittal image, by the transit time of the pulse pressure wave. Measurements obtained pre-vaping were compared to those obtained post-vaping.
Change in Femoral Artery Flow-Mediated Dilation Post-Vaping
时间窗: Flow mediated dilation calculation occurred at two time points: 1) pre-vaping, 2) 40 minutes post-vaping.
Degree of dilation (% change in cross-sectional area) of femoral artery during hyperemia (the transient increase in blood flow velocity) after e-cigarette vaping as compared to before e-cigarette vaping.
Change in Breath Hold Index Post-Vaping
时间窗: Breath hold index was calculated at two time points: 1) pre-vaping, 2) five minutes post-vaping.
Rate of increase in blood flow velocity in the superior sagittal sinus from intermittent volitional apnea.
次要结局
未报告次要终点
研究者
Felix W. Wehrli
Professor of Radiologic Science, Biochemistry and Biophysics
University of Pennsylvania