NCT03041493终止不适用
Investigation of the Effects of Electronic Cigarettes on Vascular Health
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Differences in levels of F2-isoprostanes in participants
研究概览
简要总结
The goal is find out if the use of Electronic cigarettes (EC) leads to the same changes that we see in blood vessels of traditional cigarettes (TC) users. The investigators will also enroll non-smokers as "controls", against which they will measure changes in blood vessels in TC and EC users.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female between 18 and 50 years of age.
- •Good general health with no history of diabetes, coronary artery disease, peripheral arterial disease, chronic disease or hypertension.
- •Ability to sign an informed consent.
- •Tobacco product users will have additional inclusion criteria:
- •For TC smokers, daily TC smoking in the past 6 months, at least 10 cigarettes per day, with no EC exposure in the past 6 months
- •For EC users, daily EC use in the past 6 months, at least 10 sessions per day, with no TC exposure in the past 6 month
- •For non-smokers, no significant lifetime exposure to any nicotine-containing product, where significant exposure is defined as daily use of any nicotine-containing product for more than one week or once monthly use for more than 6 months.
排除标准
- •History of renal disease, hypertension, diabetes, congestive heart failure or emphysema
- •Use of ACE inhibitors, Angiotensin II receptor blockers, diuretics, aldosterone, renin blockers, aspirin, statins, sildenafil (or other PDE5 inhibitors) and NSAIDs.
- •History of substance abuse
- •Currently using nicotine replacement or other tobacco cessation products or intentionally abstaining from nicotine-containing products
- •IV contrast exposure in the past 1 month
- •Inability to place an IV catheter or draw blood for any reason
- •Pregnant women or breastfeeding
- •Potential subjects will be asked if they are pregnant. Verbal confirmation of pregnancy will be sufficient.
- •Fever of >101°F or BP >180/95
结局指标
主要结局
Differences in levels of F2-isoprostanes in participants
时间窗: 2 years
F2-isoprostanes in blood and urine
次要结局
未报告次要终点
研究者
研究点 (2)
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