Sapienza University
Roma, 00161, Italy
NCT Number: NCT03301129
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Roma, 00161, Italy
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
See arm/group descriptions.
Time frame: up to 24 weeks
flow-mediated dilatation (FMD) assessed by vascular ultrasound
Time frame: up to 24 weeks
Soluble Nox2-derived peptide, a direct marker of NADPH oxidase activation
Time frame: up to 24 weeks
evaluation of sPselectin, thromboxane and aggregation as markers of platelet activation
University of Roma La Sapienza
Other
Effects on Oxidative Stress and Platelet Activation of Traditional Cigarettes, E-cigarettes and IQOS Cigarettes: A Randomized in Vivo Study.
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