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临床试验/NCT03301129
NCT03301129已完成不适用

Effects on Oxidative Stress and Platelet Activation of Traditional Cigarettes, E-cigarettes and IQOS Cigarettes: A Randomized in Vivo Study.

University of Roma La Sapienza2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年10月15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
发起方
入组人数
20
试验地点
2
主要终点
Endothelial dysfunction

研究概览

简要总结

Electronic cigarettes (E-cigarettes) and new heat-not-burn tobacco products such as IQOS®, an electronic device that heats a cigarette-like stick without combustion, are a modern and technological surrogate of traditional tobacco cigarettes (T-cigarettes), that are entering in the commercial market. While the negative effects of the traditional cigarette are well known, little data are reported in scientific literature on the risks on the health by these new smoking devices. Endothelial dysfunction evaluated by flow-mediated dilatation (FMD), oxidative stress and platelet activation have been recognized as a hallmark of preclinical systemic atherosclerosis and as a useful marker to stratify the risk of cardiovascular disease in patients at risk or with established clinically significant atherosclerosis. Since no data are reported about the effects of these new smoking device on oxidative stress, platelet activation and FMD, the investigators designed a human study assessing if these new smoking devices have effects on healthy smokers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Smokers volunteers, minimum age 18 years

排除标准

  • no history of acute or chronic organic, metabolic and inflammatory diseases;
  • no fever and infections in the last 3 months;
  • no history of cardiovascular pathological symptoms;
  • no allergies;
  • none of the participants took vitamin E, other antioxidant supplements or other drugs potentially affecting oxidative stress or FMD
  • women were not menstruating when the experiment was performed.

研究组 & 干预措施

Heat-not-burn tobacco products (IQOS)

Experimental

smoke one IQOS cigarette (with a mean nicotine content of 0.6 mg according to package label).

干预措施: Smoke (Behavioral)

Traditional cigarette

Experimental

smoke one Traditional cigarette (with a mean nicotine content of 0.6 mg according to package label) and in a sub-group smoke a sham cigarette (an traditional cigarette without combustion).

干预措施: Smoke (Behavioral)

Electronic cigarette

Experimental

smoke a tobacco-flavored Electronic cigarette (9 puffs approximately equivalent to 0.6 mg of nicotine content) and in a sub-group smoke a sham cigarette (an electronic cigarette without nicotine).

干预措施: Smoke (Behavioral)

结局指标

主要结局

Endothelial dysfunction

时间窗: up to 24 weeks

flow-mediated dilatation (FMD) assessed by vascular ultrasound

Oxidative stress

时间窗: up to 24 weeks

Soluble Nox2-derived peptide, a direct marker of NADPH oxidase activation

次要结局

  • Platelet activation(up to 24 weeks)

研究者

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Roberto Carnevale

Principal Investigator

University of Roma La Sapienza

研究点 (2)

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