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.

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.

Study Overview

• Status: Completed
• Conditions: Endothelial Dysfunction; Platelet Activation; Oxidative Stress Induction
• Intervention / Treatment: Behavioral: Smoke

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00161
    • Sapienza University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Traditional cigarette; 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).	Behavioral: Smoke; See arm/group descriptions.
EXPERIMENTAL: Electronic cigarette; 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).	Behavioral: Smoke; See arm/group descriptions.
EXPERIMENTAL: Heat-not-burn tobacco products (IQOS); smoke one IQOS cigarette (with a mean nicotine content of 0.6 mg according to package label).	Behavioral: Smoke; See arm/group descriptions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endothelial dysfunction	flow-mediated dilatation (FMD) assessed by vascular ultrasound	up to 24 weeks
Oxidative stress	Soluble Nox2-derived peptide, a direct marker of NADPH oxidase activation	up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Platelet activation	evaluation of sPselectin, thromboxane and aggregation as markers of platelet activation	up to 24 weeks

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza
• Collaborators: Coluzzi Flaminia; Peruzzi Mariangela; Nocella Cristina; Loffredo Lorenzo; Marullo Antonino G.M.; Valenti Valentina; Chimenti Isotta; De Falco Elena; Sciarretta Sebastiano
• Investigators: Study Director: Giacomo Frati, MD, Sapienza University of Rome, Policlinico Umberto I

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 15, 2017
• Primary Completion (ACTUAL): January 30, 2018
• Study Completion (ACTUAL): February 25, 2018

Study Registration Dates

• First Submitted: September 23, 2017
• First Submitted That Met QC Criteria: September 27, 2017
• First Posted (ACTUAL): October 4, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 29, 2018
• Last Update Submitted That Met QC Criteria: March 26, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 3241

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: identified individual participant data for all outcomes measures will be made available to other reserachers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No