Oxidative Stress InductionNCT03301129
Role of Traditional Cigarettes, Electronic and IQOS Cigarettes on Oxidative Stress.
A study testing Smoke in people with Oxidative Stress Induction and Endothelial Dysfunction, run by University of Roma La Sapienza at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress Induction, Endothelial Dysfunction, Platelet Activation
- What is being tested?
- Smoke
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 15 Oct 2017to 25 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Smokers volunteers, minimum age 18 years
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Smoke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmokeBehavioural
See arm/group descriptions.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: Behavioral: Smoke |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial dysfunction
flow-mediated dilatation (FMD) assessed by vascular ultrasound
Measured: up to 24 weeks
Oxidative stress
Soluble Nox2-derived peptide, a direct marker of NADPH oxidase activation
Measured: up to 24 weeks
Secondary outcomes (1)
Platelet activation
evaluation of sPselectin, thromboxane and aggregation as markers of platelet activation
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start15 Oct 2017
- Primary completion30 Jan 2018
- Study completion25 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oxidative Stress InductionStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Collaborators
- Coluzzi Flaminia, Peruzzi Mariangela, Nocella Cristina, Loffredo Lorenzo, Marullo Antonino G.M., Valenti Valentina, Chimenti Isotta, De Falco Elena, Sciarretta Sebastiano
- Responsible party
- Principal investigator, Roberto Carnevale, University of Roma La Sapienza
- Investigators
- Giacomo Frati, MD, Study director, Sapienza University of Rome, Policlinico Umberto I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03301129
- Sponsor's protocol ID
- 3241
- Status last verified
- Mar 2018
- First submitted
- 23 Sep 2017
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: identified individual participant data for all outcomes measures will be made available to other reserachers.
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.
PubMed 30879375
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on Oxidative Stress and Platelet Activation of Traditional Cigarettes, E-cigarettes and IQOS Cigarettes: A Randomized in Vivo Study.
- ClinicalTrials.gov ID
- NCT03301129
- Acronym / sponsor ID
- 3241
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Collaborators
- Coluzzi Flaminia, Peruzzi Mariangela, Nocella Cristina, Loffredo Lorenzo, Marullo Antonino G.M., Valenti Valentina, Chimenti Isotta, De Falco Elena, Sciarretta Sebastiano
- Study start
- 15 Oct 2017 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 25 Feb 2018 (actual)
- First posted
- 4 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Traditional cigarette | Experimental | Behavioral: Smokesmoke 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 | Behavioral: Smokesmoke 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 | Behavioral: Smokesmoke one IQOS cigarette (with a mean nicotine content of 0.6 mg according to package label). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Smokers volunteers, minimum age 18 years
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmokeSee arm/group descriptions. | Behavioural | Electronic cigarette, Heat-not-burn tobacco products (IQOS), Traditional cigarette |
Primary outcome
Endothelial dysfunction
Time frame: up to 24 weeks
flow-mediated dilatation (FMD) assessed by vascular ultrasound
Oxidative stress
Time frame: up to 24 weeks
Soluble Nox2-derived peptide, a direct marker of NADPH oxidase activation
1 secondary outcome
Platelet activation
Time frame: up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Derived from this study: PubMed 30879375Biondi-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.
- Individual participant dataSharing planned: Undecided. identified individual participant data for all outcomes measures will be made available to other reserachers.
Related trials for Oxidative Stress Induction
Recruiting
Acute Cryotherapy on Musculoskeletal Function and Biomarkers
Exercise Induced Muscle Damage, Cryotherapy
Enrolling by invitation
Rutin and Ascorbic Acid for Prevention of Vancomycin-Induced Nephrotoxicity in Adult Patients" - a Clinical Trial Protocol Evaluating Whether Combined Rutin/Vitamin C Supplementation Reduces Kidney Toxicity From Vancomycin, Compared to Vitamin C Alone and Control.
Nephrotoxicity, Acute Kidney Injuries
RecruitingObservational study
Gene and Molecular Pathways of Ozone Treatment Response in Gynecological Tumor Patients With Chronic Pelvic Pain Secondary to Cancer Treatment
Chronic Pelvic Pain Syndrome (CPPS), Radiation-Induced Disorder
RecruitingPhase 2/3
Gut Microbiome Profiles in Patients With Chemotherapy-induced Neuropathy in the RCT OzoParQT (NCT06706544).
Chemotherapy Induced Peripheral Neuropathy (CIPN), Paresthesia
RecruitingObservational study
Patients Referred to the Chronic Pain Unit for Palliative Treatment With Ozone Therapy Between 2026 and 2029.
Chemotherapy-Induced Peripheral Neuropathy, Radiation Toxicity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giacomo Frati, MD study director
Sapienza University of Rome, Policlinico Umberto I
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoke in people with Oxidative Stress Induction and Endothelial Dysfunction, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial dysfunction (time frame: up to 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03301129, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.