Clinical Trials Directory

Trials / Completed

CompletedNCT03301129

Role of Traditional Cigarettes, Electronic and IQOS Cigarettes on Oxidative Stress.

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
20 (actual)
Sponsor
University of Roma La Sapienza · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSmokeSee arm/group descriptions.

Timeline

Start date
2017-10-15
Primary completion
2018-01-30
Completion
2018-02-25
First posted
2017-10-04
Last updated
2018-03-29

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT03301129. Inclusion in this directory is not an endorsement.