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OpenTrials
Completed

NCT Number: NCT03301129

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sapienza University

Roma, 00161, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Smoke

Behavioral

See arm/group descriptions.

Primary outcomes

  1. Endothelial dysfunction

    Time frame: up to 24 weeks

    flow-mediated dilatation (FMD) assessed by vascular ultrasound

  2. Oxidative stress

    Time frame: up to 24 weeks

    Soluble Nox2-derived peptide, a direct marker of NADPH oxidase activation

Secondary outcomes

  1. Platelet activation

    Time frame: up to 24 weeks

    evaluation of sPselectin, thromboxane and aggregation as markers of platelet activation

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Collaborators

  • Chimenti Isotta
  • Coluzzi Flaminia
  • De Falco Elena
  • Loffredo Lorenzo
  • Marullo Antonino G.M.
  • Nocella Cristina
  • Peruzzi Mariangela
  • Sciarretta Sebastiano
  • Valenti Valentina

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 4, 2017
Registry last updated
Mar 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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