Clinical trial NCT03301129: Role of Traditional Cigarettes, Electronic and IQOS Cigarettes on Oxidative Stress.
Official title: Effects on Oxidative Stress and Platelet Activation of Traditional Cigarettes, E-cigarettes and IQOS Cigarettes: A Randomized in Vivo Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxidative Stress Induction
Endothelial Dysfunction
Platelet Activation
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
Collaborators: name: Coluzzi Flaminia
name: Peruzzi Mariangela
name: Nocella Cristina
name: Loffredo Lorenzo
name: Marullo Antonino G.M.
name: Valenti Valentina
name: Chimenti Isotta
name: De Falco Elena
name: Sciarretta Sebastiano
First posted: 2017-10-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Smokers volunteers, minimum age 18 years

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Endothelial dysfunction
timeFrame: up to 24 weeks
measure: Oxidative stress
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Platelet activation
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Sapienza University
Study officials:
affiliation: Sapienza University of Rome, Policlinico Umberto I
name: Giacomo Frati, MD
role: STUDY_DIRECTOR
References:
citation: Biondi-Zoccai G, Sciarretta S, Bullen C, Nocella C, Violi F, Loffredo L, Pignatelli P, Perri L, Peruzzi M, Marullo AGM, De Falco E, Chimenti I, Cammisotto V, Valenti V, Coluzzi F, Cavarretta E, Carrizzo A, Prati F, Carnevale R, Frati G. Acute Effects of Heat-Not-Burn, Electronic Vaping, and Traditional Tobacco Combustion Cigarettes: The Sapienza University of Rome-Vascular Assessment of Proatherosclerotic Effects of Smoking ( SUR - VAPES ) 2 Randomized Trial. J Am Heart Assoc. 2019 Mar 19;8(6):e010455. doi: 10.1161/JAHA.118.010455.