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

NCT03301129 | Completed DMC

• 1 other identifier: 3241
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Oxidative Stress Induction; Endothelial Dysfunction; Platelet Activation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Platelet activation

  up to 24 weeks

Study Arms (3)

Traditional cigarette

EXPERIMENTAL

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

Electronic cigarette

EXPERIMENTAL

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

Heat-not-burn tobacco products (IQOS)

EXPERIMENTAL

smoke one IQOS cigarette (with a mean nicotine content of 0.6 mg according to package label).

Behavioral: Smoke

Interventions

Smoke BEHAVIORAL

See arm/group descriptions.

Electronic cigarette; Heat-not-burn tobacco products (IQOS); Traditional cigarette

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Smokers volunteers, minimum age 18 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Roma La Sapienza: lead
• Coluzzi Flaminia: collaborator
• Peruzzi Mariangela: collaborator
• Nocella Cristina: collaborator
• Loffredo Lorenzo: collaborator
• Marullo Antonino G.M.: collaborator
• Valenti Valentina: collaborator
• Chimenti Isotta: collaborator
• De Falco Elena: collaborator
• Sciarretta Sebastiano: collaborator

Study Sites (1)

Sapienza University

Roma, 00161, Italy

Location

Related Publications (1)

• 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.

  PMID: 30879375 DERIVED

MeSH Terms

Interventions

Smoke

Intervention Hierarchy (Ancestors)

Particulate Matter; Complex Mixtures

Study Officials

• Giacomo Frati, MD

  Sapienza University of Rome, Policlinico Umberto I

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 23, 2017
• First Posted: October 4, 2017
• Study Start: October 15, 2017
• Primary Completion: January 30, 2018
• Study Completion: February 25, 2018
• Last Updated: March 29, 2018

Record last verified: 2018-03

Locations

IT (1)