The Effects of I Quit Ordinary Smoking on the Arterial Wall and Endothelial Glycocalyx Properties of Smokers
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Chronic I quit ordinary smoking (IQOS) effects on Exhaled Carbon monoxide (CO)
研究概览
简要总结
I quit ordinary smoking (IQOS) is proposed as a bridge to smoking cessation. In this study the investigators will examine its effects on aortic elasticity, glycocalyx integrity, and exhaled carbon monoxide (CO) concentration, both acutely and after 1 month of use.
详细描述
Two smokers groups matched for age and sex will be assessed:
- a group of 30 current smokers with no diagnosed cardiovascular disease as the control group for chronic phase
- a group of 30 current smokers with no diagnosed cardiovascular disease who will be using the I quit ordinary smoking (IQOS) for 1 month.
In the acute phase all 60 smokers will undergo a "sham" smoking for 7 minutes. Afterwards all 60 smokers will be randomized to smoke either a normal cigarette or IQOS and the after 60 minute washout period these subjects will be crossed over to the altenate mode of smoking (IQOS or normal cigarette respectively).
After the completion of the acute phase all 60 smokers will start the use of IQOS for one month.
In the acute phase, measurements will be performed at baseline, after sham smoking and after smoking of the normal cigarette or IQOS. The chronic phase measurements will be performed 1 month after use IQOS. Thirty current smokers of similar age and sex will serve as controls and will have measurements at baseline and 1 month after baseline assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Active conventional cigarette smoker
排除标准
- •Health condition adversely affected by smoking
- •History or presence of cardiovascular disease
研究组 & 干预措施
IQOS
I quit ordinary smoking (IQOS) assistes cessation program
干预措施: I quit ordinary smoking (IQOS) (Device)
Smoker control
Conventional cigarette smoking continuation
干预措施: Conventional cigarette (Other)
结局指标
主要结局
Chronic I quit ordinary smoking (IQOS) effects on Exhaled Carbon monoxide (CO)
时间窗: 1 month
CO concentration was measured the exhaled carbon as parts per million-ppm by the device Smokerlyzer, Covita, Bedfont, CA, USA). Participants were instructed not to smoke the night before and the morning before the CO measurements and to hold their breath for 10 sec before exhaling to the mouthpiece.
Chronic I quit ordinary smoking (IQOS) effects on endothelial function
时间窗: 1 month
Endothelial function was assessed by measuring coronary flow reserve of Left anterior descending artery. Coronary flow reserve was estimated by Doppler echocardiography as the ratio of coranary flow velocity after bolus intravenous adenosine infusion to coronary flow velocity at rest.
Acute I quit ordinary smoking (IQOS) effects on endothelial glycocalyx thickness
时间窗: 7 minutes
Acute I quit ordinary smoking (IQOS) effects on endothelial glycocalyx thickness as assessed by perfused boundary region (PBR, micrometers) of the sublinqual arterial microvessels
Chronic I quit ordinary smoking (IQOS) effects on pulse wave velocity
时间窗: 1 month
Chronic I quit ordinary smoking (IQOS) effects on pulse wave velocity (PWV, m/s) using tonometry
Chronic I quit ordinary smoking (IQOS) effects in left ventricular function
时间窗: 1 month
Left Ventricular function is assessed by Global Longitudinal Strain by speckle tracking echocardiography
Chronic I quit ordinary smoking (IQOS) effects on endothelial glycocalyx thickness
时间窗: 1 month
Chronic I quit ordinary smoking (IQOS) effects on endothelial glycocalyx thickness as assessed by perfused boundary region (PBR, micrometers) of the sublinqual arterial microvessels
Acute I quit ordinary smoking (IQOS) effects on Exhaled Carbon monoxide (CO)
时间窗: 7 minutes
CO concentration was measured the exhaled carbon as parts per million-ppm by the device Smokerlyzer, Covita, Bedfont, CA, USA). Participants were instructed not to smoke the night before and the morning before the CO measurements and to hold their breath for 10 sec before exhaling to the mouthpiece.
Acute I quit ordinary smoking (IQOS) effects on pulse wave velocity
时间窗: 7 minutes
Acute I quit ordinary smoking (IQOS) effects on pulse wave velocity (PWV, m/s) using tonometry
次要结局
- Chronic I quit ordinary smoking (IQOS) effects on myocardial work.(1 month)
- Chronic I quit ordinary smoking (IQOS) effects on platelet activation.(1 month)
- Chronic I quit ordinary smoking (IQOS) effects on arterial stiffness.(1 month)
- Acute I quit ordinary smoking (IQOS) effects on platelet activation.(7 minutes)
研究者
Ignatios Ikonomidis
Associate Professor
University of Athens