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临床试验/NCT04550026
NCT04550026已完成不适用

Cardiovascular Effects of Heated Tobacco Products (HTP)

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2020年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
1
主要终点
Endothelial progenitor cells

研究概览

简要总结

This is a human randomized controlled cross-over study where the effects of heated tobacco products (HTP) on vascular function, microcirculation and thrombosis is assessed.

详细描述

The World Health Organization estimates that smoking is one of the leading causes of premature death worldwide with an estimated 5-8 million lives lost annually due to tobacco usage (1).

Heated tobacco products (HTP) is a new form of tobacco products. HTP usually consists of a pod with tobacco that is mixed with glycerol which is inserted into a heating chamber. HTP is not combusted but only heated (2). Previous studies into smoking cessation with regular cigarettes and electronic cigarettes have suggested a risk for double usage instead of cessation, augmenting a nicotine addiction (3-5). There is a risk that HTP use simply enhances nicotine usage and smoking addiction.

There is limited data on the health effects of HTP. A majority of the studies available have reported conflicts of interest to manufacturers of HTP (11). It has been shown that aerosols from HTP contain toxic compounds and free radicals just as in regular cigarette smoke, albeit in lower concentrations (6-8). Furthermore, aerosols from HTP can spread in a room, enabling passive exposure (9). It has been shown that there is a decrease in harmful biomarkers in smokers that switch to HTP after 5 days of usage but also of a higher HTP consumption compared to regular smoking (12). There are few studies on effects of HTP in humans. Nabavizadeh et al has shown impaired endothelial function in rats after exposure to IQOS (10).


Subjects and criteria:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Normal health declaration

排除标准

  • •Any form of cardiovascular disease
  • •Any form of pulmonary disease like asthma or COPD
  • •Any form of systemic or chronic disorder like rheumatologic or metabolic diseases. - Symptoms of infection or inflammation within 4 weeks of the study
  • •Pregnancy

研究组 & 干预措施

Inhalation of HTP

Experimental

Inhalation of HTP for 30 minutes

干预措施: HTP inhalation (Other)

Sham inhalation of HTP

Active Comparator

Sham usage of HTP for 30 minutes

干预措施: HTP inhalation (Other)

结局指标

主要结局

Endothelial progenitor cells

时间窗: change from baseline up to 3 hours following exposures

EPC

microcirculation microcirculation

时间窗: change from baseline and 1 hour following exposures

Iontophoresis and laser speckle contrast imaging (LSCI),

thrombosis (total thrombus formation analysis system)

时间窗: change from baseline up to 3 hour following exposures]

T-TAS (area under the curve, flow pressure change)

arterial stiffness

时间窗: change from baseline up to 3 hour following exposures]

PWV, PWA

Microvesicles

时间窗: change from baseline up to 3 hour following exposures

microvesicles of leukocyte, endothelial and platelet origin (MVs/microliter)

NETs(neutrophil extracellular traps)

时间窗: change from baseline up to 3 hours following exposures

blood levels of H3Cit using ELISA

capillary microscopy

时间窗: change from baseline to 1 hour following exposures]

capillary blood cell velocity, CBV, mm/s

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Magnus Lundbäck

MD, Associate Professor

Karolinska Institutet

研究点 (1)

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