Smoking CessationNCT03039920
The Effects of Electronic Cigarette Smoking on the Arterial Wall and Endothelial Glycocalyx Properties of Smokers
A study testing Electronic cigarette and Conventional cigarette in people with Smoking Cessation, run by University of Athens at 1 site in Greece.
Trial summary
Electronic cigarette is proposed as a bridge to smoking cessation. In this study we examine its effects on aortic elasticity, glycocalyx integrity, and exhaled carbon monoxide (CO) concentration and platelet function, both acutely and after 1 month of use. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Electronic cigarette and Conventional cigarette
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteGreece
- Study dates
- 31 Jan 2017to Jun 2022
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Active conventional cigarette smoker
Who cannot join
- Health condition adversely affected by smoking, history or presence of cardiovascular disease
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
''Attikon'' University General Hospital
Athens, Attica, 12462
Ignatios Ikonomidis, MD, 00302105831264
Ignatios Ikonomidis, MD
About this study
Electronic cigarette is proposed as a bridge to smoking cessation. In this study we examine its effects on aortic elasticity, glycocalyx integrity, and exhaled carbon monoxide (CO) concentration and platelet function, both acutely and after 1 month of use.
Read the detailed description
Two smoker groups matched for age and sex will be assessed:
- a group of 30 current smokers with no diagnosed cardiovascular disease as the control group for chronic phase
- a group of 30 current smokers with no diagnosed cardiovascular disease who will be using the electronic cigarette with nicotine for 1 month
In the acute phase all 60 smokers will undergo a "sham" smoking for 7 minutes. Afterwards 30 out of 60 smokers will be randomized to smoke either a normal cigarette or an electronic cigarette with nicotine and after a 60 minute washout period these subjects will be crossed over to the alternate mode of smoking (electronic with nicotine or normal cigarette respectively).
The remaining 30 smokers will be randomized to smoke either a normal cigarette or an electronic cigarette without nicotine and after a 60 minute washout period these subjects will be crossed over to the alternate mode of smoking (electronic without nicotine or normal cigarette respectively.
After the completion of the acute phase all 60 smokers will start the use of an electronic cigarette for one month.
In the acute phase, measurements will be performed at baseline, after sham smoking and after smoking of the normal or electronic cigarette (with or without nicotine). The chronic phase measurements will be performed 1 month after use electronic cigarette with nicotine. Thirty current smokers of similar age and sex will serve as controls and will have measurements at baseline and 1 month after baseline assessment. The nicotine concentration of the electronic cigarette fluid used during both phases will be 12 mg/dL, while the participants will be allowed to use their cigarette of preference in the acute phase. In both phases we will assess a) the aortic pulse wave velocity (PWV) and augmentation index (AIx) by Arteriograph and Complior; b) the perfusion boundary region of the sublingual arterial microvessels using Sideview, Darkfield imaging (Microscan, Glycocheck); c) the exhaled carbon monoxide (CO) level (parts per million -ppm) as a smoking status marker; d) the vital signs; e) an electrocardiogram; and f) plasma levels of C- reactive protein (CRP), transforming growth factor-b (TGF-b), lipoprotein associated phospholipase A2 (LP- LPA2), tumor necrosis factor- α (TNF-α), interleukins 6 and 10 (IL-6 and -10), procollagen propeptide type III (PIIINP), matrix metalloproteinase 2 and 9 (MMP-2 and -9), and macrophage-colony stimulating factor (MCSF), malondialdehyde (MDA) and protein carbonyls (PC) and platelet function tests using the novel Platelet Function Analyzer PFA-100 and the traditional Light Transmission Aggregometry (LTA)
- Conditions
- Smoking Cessation
- Being tested
- Electronic cigarette, Conventional cigarette
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic cigaretteOther
Smoking of electronic cigarette
Conventional cigaretteOther
Smoking tobacco cigarette
| Study group | Role | What they receive |
|---|---|---|
| Electronic cigarette with or without nicotine | Active comparator | Electronic cigarette assisted cessation program Receives: Other: Electronic cigarette |
| Smoker control | Active comparator | Conventional cigarette smoking continuation Receives: Other: Conventional cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute electronic cigarette vaping effects on arterial stiffness.
Acute electronic cigarette vaping effects on arterial stiffness as assessed by pulse wave velocity (PWV, m/sec). PWV (m/sec) was measured by using tonometry by Complior (Alam Medical, Vincennes, France). Two non-invasive pressure sensors were used to record the carotid and femoral waveforms and the distance between the two arterial sites was measured with a tape measure.
Measured: 7 minutes
Acute electronic cigarette vaping effects on endothelial integrity.
Acute electronic cigarette vaping effects on endothelial integrity as assessed by measuring endothelial glycocalyx thickness. We measured the perfused boundary region (PBR) of the sublingual arterial microvessels (ranged from 5 to 25 μm) using Sidestream Darkfield Imaging (Microscan, Glycocheck, Microvascular Health Solutions Inc., Salt Lake City, UT, USA).
Measured: 7 minutes
Chronic electronic cigarette vaping effects on arterial stiffness.
Chronic electronic cigarette vaping effects on arterial stiffness, as assessed by pulse wave velocity (PWV, m/sec). PWV (m/sec) was measured by using tonometry by Complior (Alam Medical, Vincennes, France). Two non-invasive pressure sensors were used to record the carotid and femoral waveforms and the distance between the two arterial sites was measured with a tape measure.
Measured: 1 month
Chronic electronic cigarette vaping effects on endothelial integrity.
Chronic electronic cigarette vaping effects on endothelial integrity as assessed by measuring endothelial glycocalyx thickness. We measured the perfused boundary region (PBR) of the sublingual arterial microvessels (ranged from 5 to 25 μm) using Sidestream Darkfield Imaging (Microscan, Glycocheck, Microvascular Health Solutions Inc., Salt Lake City, UT, USA).
Measured: 1 month
Chronic electronic cigarette vaping effects on platelet aggregation.
Chronic electronic cigarette vaping effects on platelet function as assessed by Light Transmission Aggregometry (LTA). We measured both maximum (peak) and late platelet aggregation (%) (at 6 minutes) after addition of epinephrine (as stimulant) in platelet rich plasma.The 100% line was set using platelet poor plasma and a 0% baseline established with platelet rich plasma before addition of the agonist(epinephrine). Platelet aggregation is experssed as % of the 100% line
Measured: 1 month
Chronic electronic cigarette vaping effects on high-shear stress-dependent platelet function.
Chronic electronic cigarette vaping effects on high-shear stress-dependent platelet function as assesed by PFA-100. The instrument estimates the ability of platelets activated in a high shear environment to occlude an aperture in a membrane coated with collagen and epinephrine (CEPI).The time taken for flow across the membrane to stop (closure time, CT, seconds) is recorded as measure of platelet function. Platelet adhesion and aggregation following a vascular injury is simulated in vitro by PFA.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study start31 Jan 2017
- Primary completionDec 2021 (estimated)
- Study completionJun 2022 (estimated)
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 Smoking CessationStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ignatios Ikonomidis, University of Athens
- Investigators
- Ignatios Ikonomidis, Dr, Principal investigator, Attikon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039920
- Sponsor's protocol ID
- 698/11-3-15
- Status last verified
- Apr 2020
- First submitted
- 28 Jan 2017
- Last updated
- 6 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ikonomidis I, Vlastos D, Kourea K, Kostelli G, Varoudi M, Pavlidis G, Efentakis P, Triantafyllidi H, Parissis J, Andreadou I, Iliodromitis E, Lekakis J. Electronic Cigarette Smoking Increases Arterial Stiffness and Oxidative Stress to a Lesser Extent Than a Single Conventional Cigarette: An Acute and Chronic Study. Circulation. 2018 Jan 16;137(3):303-306. doi: 10.1161/CIRCULATIONAHA.117.029153. No abstract available.
PubMed 29335291
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Electronic Cigarette Smoking on the Arterial Wall and Endothelial Glycocalyx Properties of Smokers
- ClinicalTrials.gov ID
- NCT03039920
- Acronym / sponsor ID
- 698/11-3-15
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- 31 Jan 2017 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 1 Feb 2017 (estimated)
- 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 cigarette is proposed as a bridge to smoking cessation. In this study we examine its effects on aortic elasticity, glycocalyx integrity, and exhaled carbon monoxide (CO) concentration and platelet function, both acutely and after 1 month of use.
Detailed description
Two smoker groups matched for age and sex will be assessed:
- a group of 30 current smokers with no diagnosed cardiovascular disease as the control group for chronic phase
- a group of 30 current smokers with no diagnosed cardiovascular disease who will be using the electronic cigarette with nicotine for 1 month
In the acute phase all 60 smokers will undergo a "sham" smoking for 7 minutes. Afterwards 30 out of 60 smokers will be randomized to smoke either a normal cigarette or an electronic cigarette with nicotine and after a 60 minute washout period these subjects will be crossed over to the alternate mode of smoking (electronic with nicotine or normal cigarette respectively).
The remaining 30 smokers will be randomized to smoke either a normal cigarette or an electronic cigarette without nicotine and after a 60 minute washout period these subjects will be crossed over to the alternate mode of smoking (electronic without nicotine or normal cigarette respectively.
After the completion of the acute phase all 60 smokers will start the use of an electronic cigarette for one month.
In the acute phase, measurements will be performed at baseline, after sham smoking and after smoking of the normal or electronic cigarette (with or without nicotine). The chronic phase measurements will be performed 1 month after use electronic cigarette with nicotine. Thirty current smokers of similar age and sex will serve as controls and will have measurements at baseline and 1 month after baseline assessment. The nicotine concentration of the electronic cigarette fluid used during both phases will be 12 mg/dL, while the participants will be allowed to use their cigarette of preference in the acute phase. In both phases we will assess a) the aortic pulse wave velocity (PWV) and augmentation index (AIx) by Arteriograph and Complior; b) the perfusion boundary region of the sublingual arterial microvessels using Sideview, Darkfield imaging (Microscan, Glycocheck); c) the exhaled carbon monoxide (CO) level (parts per million -ppm) as a smoking status marker; d) the vital signs; e) an electrocardiogram; and f) plasma levels of C- reactive protein (CRP), transforming growth factor-b (TGF-b), lipoprotein associated phospholipase A2 (LP- LPA2), tumor necrosis factor- α (TNF-α), interleukins 6 and 10 (IL-6 and -10), procollagen propeptide type III (PIIINP), matrix metalloproteinase 2 and 9 (MMP-2 and -9), and macrophage-colony stimulating factor (MCSF), malondialdehyde (MDA) and protein carbonyls (PC) and platelet function tests using the novel Platelet Function Analyzer PFA-100 and the traditional Light Transmission Aggregometry (LTA)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electronic cigarette with or without nicotine | Active comparator | Other: Electronic cigaretteElectronic cigarette assisted cessation program |
| Smoker control | Active comparator | Other: Conventional cigaretteConventional cigarette smoking continuation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Active conventional cigarette smoker
Key exclusion criteria (1 listed)
- Health condition adversely affected by smoking, history or presence of cardiovascular disease
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 |
|---|---|---|
| Electronic cigaretteSmoking of electronic cigarette | Other | Electronic cigarette with or without nicotine |
| Conventional cigaretteSmoking tobacco cigarette | Other | Smoker control |
Primary outcome
Acute electronic cigarette vaping effects on arterial stiffness.
Time frame: 7 minutes
Acute electronic cigarette vaping effects on arterial stiffness as assessed by pulse wave velocity (PWV, m/sec). PWV (m/sec) was measured by using tonometry by Complior (Alam Medical, Vincennes, France). Two non-invasive pressure sensors were used to record the carotid and femoral waveforms and the distance between the two arterial sites was measured with a tape measure.
Acute electronic cigarette vaping effects on endothelial integrity.
Time frame: 7 minutes
Acute electronic cigarette vaping effects on endothelial integrity as assessed by measuring endothelial glycocalyx thickness. We measured the perfused boundary region (PBR) of the sublingual arterial microvessels (ranged from 5 to 25 μm) using Sidestream Darkfield Imaging (Microscan, Glycocheck, Microvascular Health Solutions Inc., Salt Lake City, UT, USA).
Chronic electronic cigarette vaping effects on arterial stiffness.
Time frame: 1 month
Chronic electronic cigarette vaping effects on arterial stiffness, as assessed by pulse wave velocity (PWV, m/sec). PWV (m/sec) was measured by using tonometry by Complior (Alam Medical, Vincennes, France). Two non-invasive pressure sensors were used to record the carotid and femoral waveforms and the distance between the two arterial sites was measured with a tape measure.
Chronic electronic cigarette vaping effects on endothelial integrity.
Time frame: 1 month
Chronic electronic cigarette vaping effects on endothelial integrity as assessed by measuring endothelial glycocalyx thickness. We measured the perfused boundary region (PBR) of the sublingual arterial microvessels (ranged from 5 to 25 μm) using Sidestream Darkfield Imaging (Microscan, Glycocheck, Microvascular Health Solutions Inc., Salt Lake City, UT, USA).
Chronic electronic cigarette vaping effects on platelet aggregation.
Time frame: 1 month
Chronic electronic cigarette vaping effects on platelet function as assessed by Light Transmission Aggregometry (LTA). We measured both maximum (peak) and late platelet aggregation (%) (at 6 minutes) after addition of epinephrine (as stimulant) in platelet rich plasma.The 100% line was set using platelet poor plasma and a 0% baseline established with platelet rich plasma before addition of the agonist(epinephrine). Platelet aggregation is experssed as % of the 100% line
Chronic electronic cigarette vaping effects on high-shear stress-dependent platelet function.
Time frame: 1 month
Chronic electronic cigarette vaping effects on high-shear stress-dependent platelet function as assesed by PFA-100. The instrument estimates the ability of platelets activated in a high shear environment to occlude an aperture in a membrane coated with collagen and epinephrine (CEPI).The time taken for flow across the membrane to stop (closure time, CT, seconds) is recorded as measure of platelet function. Platelet adhesion and aggregation following a vascular injury is simulated in vitro by PFA.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2020.
- Derived from this study: PubMed 29335291Ikonomidis I, Vlastos D, Kourea K, Kostelli G, Varoudi M, Pavlidis G, Efentakis P, Triantafyllidi H, Parissis J, Andreadou I, Iliodromitis E, Lekakis J. Electronic Cigarette Smoking Increases Arterial Stiffness and Oxidative Stress to a Lesser Extent Than a Single Conventional Cigarette: An Acute and Chronic Study. Circulation. 2018 Jan 16;137(3):303-306. doi: 10.1161/CIRCULATIONAHA.117.029153. No abstract available.
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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.
Ignatios Ikonomidis, Dr principal investigator
Attikon Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic cigarette and Conventional cigarette in people with Smoking Cessation, run by University of Athens at 1 site in Greece.
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 1 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: status not confirmed, as of the sponsor's last update on 6 Apr 2020. 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 Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ignatios Ikonomidis, Dr (00306944805732, ignoik@otenet.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute electronic cigarette vaping effects on arterial stiffness. (time frame: 7 minutes). The study lists 6 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 NCT03039920, 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 6 Apr 2020.