MRI and Biological Markers of Acute E-Cigarette Exposure in Smokers and Vapers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Changes in magnetic resonance imaging (MRI) biomarkers of endothelial dysfunction: venous oxygen saturation
研究概览
简要总结
To examine vascular reactivity and inflammatory biomarkers via quantitative magnetic resonance imaging (MRI) and blood serum, respectively, in a crossover study where active vapers (electronic cigarette users) and smokers will undergo three separate acute exposure-episodes of electronic cigarette +/- nicotine and tobacco-cig. The MRI exams and blood draws will be performed pre- and post-exposure. The results will be compared against baseline values derived from a group of non-smokers/non-vapers, who will also undergo a blood draw and MRI.
详细描述
This work is an extension of prior funded work on the acute effects of nicotine free electronic cigarette aerosol on vascular function and inflammatory biomarkers in healthy non-smokers. Here, the investigators will examine vascular reactivity and inflammatory biomarkers using quantitative magnetic resonance imagine (MRI) and blood serum in a crossover study, with active vapers (electronic cigarette users) and smokers undergoing three, separate-day, acute exposure-episodes of smoking a tobacco cigarette, an electronic cigarette without nicotine, and an electronic cigarette with nicotine. Participants will undergo an MRI exam and a blood draw pre- and post-exposure-episode.
The investigators hypothesize that all three paradigms will cause a transient response but greatest for tobacco and nicotinized electronic cigarettes. The results will be compared against baseline values derived from a group of non-smokers/non-vapers, who will undergo a blood draw and MRI only. Eligible participants will be healthy, males and females, current, habitual users of electronic or tobacco cigarettes (except for the non-smoking/non-vaping comparison group), 21 to 45 years of age, and without co-morbidities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Blinding to nicotine and placebo containing standardized electronic research cigarettes and standardized tobacco research cigarettes.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI: 18.5 to 30
- •Current users of electronic cigarettes or tobacco cigarettes with a use history of six months or greater.
排除标准
- •Mental illness in which the participant is not of proper cognizance
- •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
- •Medication affecting vascular function
- •Antibiotics
- •Magnetic resonance imaging contraindications (metallic implants/intraocular foreign bodies, claustrophobia, cardiac/cochlear implantable electronic devices, etc.)
结局指标
主要结局
Changes in magnetic resonance imaging (MRI) biomarkers of endothelial dysfunction: venous oxygen saturation
时间窗: Pre-Inhalation (baseline) to post-inhalation (60 minutes)
Assessment of microvascular function by monitoring the changes in tissue blood oxygenation measured in percentage in response to a cuff-induced ischemia.
Changes in blood inflammatory biomarkers
时间窗: Pre-Inhalation (baseline) to post-inhalation (60 minutes)
Measured in nanograms/milliliter of plasma, the following biomarkers are collectively associated with damage to blood vessels and recruitment of immune cells into the vascular tissue leading to severe oxidative stress and tissue damage in the vasculature: biomarker of oxidative stress (c-reactive protein) and biomarkers of inflammation (NLR family pyrin domain containing 3, damage-associated molecular pattern protein HMGB1, tumor necrosis factor alpha, interleukin 1β, interleukin 18, interferon gamma, monocyte chemoattractant protein, and macrophage inflammatory protein).
Changes in magnetic resonance imaging (MRI) biomarkers of endothelial dysfunction: aortic arch
时间窗: Pre-Inhalation (baseline) to post-inhalation (60 minutes)
Changes in stiffness of aortic arch in terms of pulse-wave velocity measured in meters per second.
Changes in magnetic resonance imaging (MRI) biomarkers of endothelial dysfunction: cerebral vascular reactivity
时间窗: Pre-Inhalation (baseline) to post-inhalation (60 minutes)
Rate of change in the blood flow velocity \[centimeters per second (squared)\] in a major draining vein in response to volitional apnea.
Changes in magnetic resonance imaging (MRI) biomarkers of endothelial dysfunction: femoral artery flow-mediated dilation
时间窗: Pre-Inhalation (baseline) to post-inhalation (60 minutes)
Percentage measure of the change of a cross-sectional area of the superficial femoral artery.
Changes in magnetic resonance imaging (MRI) biomarkers of endothelial dysfunction: blood flow velocity
时间窗: Pre-Inhalation (baseline) to post-inhalation (60 minutes)
Macrovascular function is evaluated by monitoring hyperemia in response to a cuff-induced ischemia by measuring femoral artery blood flow velocity in centimeters per second.
次要结局
未报告次要终点