Vascular Effects of Regular Cigarettes Versus electronIc Cigarette Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- Change in Flow mediated Dilation (FMD) between the TC group and the EC-nicotine and EC-nicotine free groups
研究概览
简要总结
The purpose of this study is to assess the effects of electronic cigarettes-nicotine and electronic cigarette-nicotine free on endothelial function as compared to traditional cigarettes. Due to ethical reasons, we cannot fully randomise all particpants to the three arms.
Participants who wish to quit smoking will be randomized to
- Switch to electronic cigarettes containing nicotine plus flavor
- Switch to electronic cigarettes containing flavor alone Those who do not wish to quit smoking will continue on the Tobacco Cigarette arm Treatment period will be 28 days
详细描述
Electronic cigarettes (EC) are gaining popularity as an alternative to Traditional Cigarettes (TC). Despite not containing all the harmful substances seen in TC, EC are known to contain impurities that may have a detrimental impact on human health. The effects of ECs compared with TC on vascular function, inflammation and oxidative stress are unknown. It is increasingly recognised that nicotine itself has significant atherothrombotic effects. Therefore, clinicians are unable to confidently recommend ECs as a less risky alternative to TC.
Hypothesis
Endothelial function will be improved on EC compared to TC when measured by flow mediated dilatation (FMD).
Potential benefit: This study will provide further information on the potential use these devices and the risks and/or benefits associated with them, specifically in relation to vascular health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 years and over
- •Currently smoking ≥15 full strength tobacco cigarettes per day for at least 2 years, or roll-up tobacco equivalent (cigar or pipe smokers not included).
- •Willing to stop tobacco cigarettes for period of study if required
- •Willing not to use electronic cigarettes if required
- •Able to give informed consent
排除标准
- •Pregnant or lactating.
- •Women of childbearing potential who do not abstain from sex or use effective contraception.
- •On current prescribed medication for cardiovascular disease.
- •History of cardiovascular disease (excluding hypertension), diabetes, active malignance or chronic renal disease.
- •Nut allergy
- •Participation in another clinical trial (other than observational trials and registries) with an investigational product and/or intervention within 30 days before visit 1.
研究组 & 干预措施
tobacco cigarette
Intervention: tobacco cigarettes min 15/day
干预措施: Tobacco cigarette (Other)
e.cigarettes + 16mg nicotine & flavor
Intervention: One flavoured electronic cigarette 16mg nicotine/day
干预措施: electronic cigarette + 16mg nicotine & flavor (Device)
e.cigarettes + 0mg nicotine & flavour
Intervention: One electronic cigarette with flavour +0mg nicotine/day
干预措施: electronic cigarette + 0mg nicotine & flavor (Other)
结局指标
主要结局
Change in Flow mediated Dilation (FMD) between the TC group and the EC-nicotine and EC-nicotine free groups
时间窗: Baseline and 1 month
次要结局
- Change in FMD between EC-nicotine and EC-nicotine free groups(Baseline and 1 month)
- Change in Pulse Wave Velocity between the TC group and the EC-nicotine free groups.(Baseline and 1 month)
- Change in PAI-1 between the TC, EC-nicotine free and EC-nicotine groups(Baseline and 1 month)
- Change in FMD between TC and EC groups combined(Baseline and 1 month)
- Change in oxidised LDL between the TC, EC-nicotine free and EC-nicotine groups(Baseline and 1 month)
- Change in hs-CRP between the TC, EC-nicotine free and EC-nicotine groups(Baseline and 1 month)
- Change in tPA between the TC, EC-nicotine free and EC-nicotine groups(Baseline and 1 month)
- Change in Augmentation Index@75bpm between the TC group,EC-nicotine and the EC-nicotine free groups(Baseline and 1 month)
研究者
Professor. Jacob George
Professor
University of Dundee