Smoking and Ventricular Repolarization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Tpe/QT
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.
详细描述
Non-user or chronic electronic cigarette (EC) users will use an EC or control on three occasions:1) EC with nicotine, 2) EC without nicotine, 3) empty EC (control).
Chronic tobacco cigarette (TC) smokers will use a TC or control on three occasions: 1) TC with nicotine (subject's own brand), 2) research TC with very low nicotine, 3) straw (control). The electrocardiogram will be recorded before and after acute exposures and analyzed for parameters representative of ventricular repolarization.
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
- Single (Outcomes Assessor)
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
- 是
入选标准
- •Healthy non-smokers chronic TC smokers (non-e-cig users) Chronic EC smokers (Non-TC smokers)
排除标准
- •Cardiac disease, respiratory disease, diabetes
结局指标
主要结局
Tpe/QT
时间窗: Change in Tpe/QT 5 minutes before and 5 minutes after cigarette use
ratio of intervals indicative of ventricular repolarization measured on ECG
Tpe/QTc
时间窗: Change in Tpe/QTc 5 minutes before and 5 minutes after cigarette use
ratio of intervals indicative of ventricular repolarization measured on ECG
Tpe
时间窗: Change in Tpe 5 minutes before and 5 minutes after cigarette use
interval indicative of ventricular repolarization measured on ECG
次要结局
- QT(Change in QT 5 minutes before and 5 minutes after cigarette use)
- QTc(Change in QTc 5 minutes before and 5 minutes after cigarette use)
研究者
Holly R Middlekauff
Principal Investigator
University of California, Los Angeles