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

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

• Oxidative Stress Induction
• Endothelial Dysfunction
• Platelet Activation

Interventions

BEHAVIORAL

Smoke

See arm/group descriptions.

Sponsors & Collaborators

• Coluzzi Flaminia

  collaborator UNKNOWN

• Peruzzi Mariangela

  collaborator UNKNOWN

• Nocella Cristina

  collaborator UNKNOWN

• Loffredo Lorenzo

  collaborator UNKNOWN

• Marullo Antonino G.M.

  collaborator UNKNOWN

• Valenti Valentina

  collaborator UNKNOWN

• Chimenti Isotta

  collaborator UNKNOWN

• De Falco Elena

  collaborator UNKNOWN

• Sciarretta Sebastiano

  collaborator UNKNOWN

• University of Roma La Sapienza

  lead OTHER

Principal Investigators

• Giacomo Frati, MD · Sapienza University of Rome, Policlinico Umberto I

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-10-15

Primary Completion

2018-01-30

Completion

2018-02-25

Countries

• Italy

Study Locations