Acute Impact of Switching From Tobacco Cigarettes to E-Cigarettes in People Living With HIV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 4
- 主要终点
- Tpe/QTc
研究概览
简要总结
Randomized controlled trial of acute use of electronic cigarette or tobacco cigarette on parameters of ventricular repolarization and inflammation/oxidative stress.
详细描述
On separate days, participants will undergo 3 different exposures: an acute e-cigarette exposure, an acute tobacco cigarette exposure, and a sham (empty e-cigarette) control . Before and after the acute exposure, participants will have blood drawn for inflammation/oxidative stress markers and undergo a 5-minute ECG recording.
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
盲法说明
single (outcomes assessor) code
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic (> 1year) TCIG smoker HIV positive Stable ART Viral count non-detectable CD4 >500
排除标准
- •Known major illness (heart disease, diabetes, lung or liver disease) Daily recreational drug use, including cannabis >2 alcoholic drinks per day Obesity (>30 kg/m2) Recent (<3 months) infection
结局指标
主要结局
Tpe/QTc
时间窗: Change in Tpe/QTc after cigarette use
interval indicative of ventricular repolarization measured on ECG
Tpe
时间窗: Change in Tpe 5 minutes after cigarette use
interval indicative of ventricular repolarization measured on ECG
Total Cellular Reactive Oxygen Stress
时间窗: within 4 hours of cigarette use
total cellular oxidative stress measured by flow cytometry
Tpe/QT
时间窗: Change in Tpe/QT after cigarette use
interval indicative of ventricular repolarization measured on ECG
次要结局
- QT(Change in QT after cigarette use)
- QTc(Change in QTc after cigarette use)
研究者
Holly R Middlekauff
Principal Investigator
University of California, Los Angeles