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| Name | Class |
|---|---|
| Coluzzi Flaminia | UNKNOWN |
| Peruzzi Mariangela | UNKNOWN |
| Nocella Cristina | UNKNOWN |
| Loffredo Lorenzo |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Heat-not-burn tobacco products (IQOS) | Experimental | smoke one IQOS cigarette (with a mean nicotine content of 0.6 mg according to package label). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smoke | Behavioral | See arm/group descriptions. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Platelet activation | evaluation of sPselectin, thromboxane and aggregation as markers of platelet activation | up to 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giacomo Frati, MD | Sapienza University of Rome, Policlinico Umberto I | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sapienza University | Roma | 00161 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30879375 | Derived | 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. |
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identified individual participant data for all outcomes measures will be made available to other reserachers.
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| ID | Term |
|---|---|
| D012906 | Smoke |
| ID | Term |
|---|---|
| D052638 | Particulate Matter |
| D045424 | Complex Mixtures |
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| UNKNOWN |
| Marullo Antonino G.M. | UNKNOWN |
| Valenti Valentina | UNKNOWN |
| Chimenti Isotta | UNKNOWN |
| De Falco Elena | UNKNOWN |
| Sciarretta Sebastiano | UNKNOWN |
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