Smoking CessationNCT03452124
The Effects of I Quit Ordinary Smoking on the Arterial Wall and Endothelial Glycocalyx Properties of Smokers
A study testing I quit ordinary smoking (IQOS) and Conventional cigarette in people with Smoking Cessation, run by University of Athens at 1 site in Greece.
Trial summary
I quit ordinary smoking (IQOS) is proposed as a bridge to smoking cessation. In this study the investigators will examine its effects on aortic elasticity, glycocalyx integrity, and exhaled carbon monoxide (CO) concentration, 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?
- I quit ordinary smoking (IQOS) and Conventional cigarette
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteGreece
- Study dates
- 30 Mar 2018to 30 Jun 2021
- 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, 00302105832187
Ignatios Ikonomidis, MD
About this study
I quit ordinary smoking (IQOS) is proposed as a bridge to smoking cessation. In this study the investigators will examine its effects on aortic elasticity, glycocalyx integrity, and exhaled carbon monoxide (CO) concentration, both acutely and after 1 month of use.
Read the detailed description
Two smokers 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 I quit ordinary smoking (IQOS) for 1 month.
In the acute phase all 60 smokers will undergo a "sham" smoking for 7 minutes. Afterwards all 60 smokers will be randomized to smoke either a normal cigarette or IQOS and the after 60 minute washout period these subjects will be crossed over to the altenate mode of smoking (IQOS or normal cigarette respectively).
After the completion of the acute phase all 60 smokers will start the use of IQOS for one month.
In the acute phase, measurements will be performed at baseline, after sham smoking and after smoking of the normal cigarette or IQOS. The chronic phase measurements will be performed 1 month after use IQOS. Thirty current smokers of similar age and sex will serve as controls and will have measurements at baseline and 1 month after baseline assessment.
In both phases the investigators 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 (PCs).
- Conditions
- Smoking Cessation
- Being tested
- I quit ordinary smoking (IQOS), 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.
I quit ordinary smoking (IQOS)Device
I quit ordinary smoking (IQOS) assisted cessation program
Conventional cigaretteOther
Conventional cigarette smoking continuation
| Study group | Role | What they receive |
|---|---|---|
| IQOS | Active comparator | I quit ordinary smoking (IQOS) assistes cessation program Receives: Device: I quit ordinary smoking (IQOS) |
| 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 I quit ordinary smoking (IQOS) effects on pulse wave velocity
Acute I quit ordinary smoking (IQOS) effects on pulse wave velocity (PWV, m/s) using tonometry
Measured: 7 minutes
Acute I quit ordinary smoking (IQOS) effects on Exhaled Carbon monoxide (CO)
CO concentration was measured the exhaled carbon as parts per million-ppm by the device Smokerlyzer, Covita, Bedfont, CA, USA). Participants were instructed not to smoke the night before and the morning before the CO measurements and to hold their breath for 10 sec before exhaling to the mouthpiece.
Measured: 7 minutes
Acute I quit ordinary smoking (IQOS) effects on endothelial glycocalyx thickness
Acute I quit ordinary smoking (IQOS) effects on endothelial glycocalyx thickness as assessed by perfused boundary region (PBR, micrometers) of the sublinqual arterial microvessels
Measured: 7 minutes
Chronic I quit ordinary smoking (IQOS) effects on pulse wave velocity
Chronic I quit ordinary smoking (IQOS) effects on pulse wave velocity (PWV, m/s) using tonometry
Measured: 1 month
Chronic I quit ordinary smoking (IQOS) effects on endothelial glycocalyx thickness
Chronic I quit ordinary smoking (IQOS) effects on endothelial glycocalyx thickness as assessed by perfused boundary region (PBR, micrometers) of the sublinqual arterial microvessels
Measured: 1 month
Chronic I quit ordinary smoking (IQOS) effects in left ventricular function
Left Ventricular function is assessed by Global Longitudinal Strain by speckle tracking echocardiography
Measured: 1 month
Chronic I quit ordinary smoking (IQOS) effects on endothelial function
Endothelial function was assessed by measuring coronary flow reserve of Left anterior descending artery. Coronary flow reserve was estimated by Doppler echocardiography as the ratio of coranary flow velocity after bolus intravenous adenosine infusion to coronary flow velocity at rest.
Measured: 1 month
Chronic I quit ordinary smoking (IQOS) effects on endothelial function
Endothelial function was assessed by measuring Flow Mediated Vasodilation (FMD) using sonography. During a FMD test, vasodilation occurs following an acute increase in blood flow, typically induced via circulatory arrest in the arm (supra-systolic cuff occlusion) for a period of time. FMD is the percent of increase in brachial artery diameter after occlusion.
Measured: 1 month
Chronic I quit ordinary smoking (IQOS) effects on Exhaled Carbon monoxide (CO)
CO concentration was measured the exhaled carbon as parts per million-ppm by the device Smokerlyzer, Covita, Bedfont, CA, USA). Participants were instructed not to smoke the night before and the morning before the CO measurements and to hold their breath for 10 sec before exhaling to the mouthpiece.
Measured: 1 month
Secondary outcomes (4)
Acute I quit ordinary smoking (IQOS) effects on platelet activation.
Platelet activation was estimated by measuring blood levels of Thromboxane B2 (Thromboxane B2 EIA Kit Cayman Ann Arbor MI USA) A commercially available ELISA kit was used with an assay range 1.6-1000 pg/ml.
Measured: 7 minutes
Chronic I quit ordinary smoking (IQOS) effects on myocardial work.
Myocardial work (MW) was estimated by combining echo-derived left ventricular (LV) strain with brachial blood pressure to construct LV strain-pressure curves non-invasively. Brachial cuff systolic pressure measurements provide the peak systolic LV pressure value, which is combined with the input of valvular timing events that define isovolumetric and ejection phases, allowing the construction of an LV-pressure curve. This is combined with LV strain data into a pressure-strain loop (PSL), the area within which represents MW. Global MW index (GWI) is defined as the work within the LV PSL from mitral valve closure to mitral valve opening, while constructive MW (GCW) is the component of MW that contributes to LV ejection. On the contrary, wasted MW (GWW) is the work wasted as myocyte lengthening during systole, which does not contribute to LV ejection. MW efficiency (GWE) is defined as the ratio of GCW to the sum of GCW and GWW [GWE= GCW/ (GCW+GWW)].
Measured: 1 month
Chronic I quit ordinary smoking (IQOS) effects on arterial stiffness.
Arterial stiffness was estimated by calculating Total arterial compliance (TAC). TAC was evaluated utilising the stroke volume (SV) to pulse pressure (PP) ratio (SV/PP), based on the two-element Windkessel model; SV measurements were derived from two-dimensional echocardiography.
Measured: 1 month
Chronic I quit ordinary smoking (IQOS) effects on platelet activation.
Platelet activation was estimated by measuring blood levels of Thromboxane B2 (Thromboxane B2 EIA Kit Cayman Ann Arbor MI USA) A commercially available ELISA kit was used with an assay range 1.6-1000 pg/ml.
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 posted2 Mar 2018
- Study start30 Mar 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion30 Jun 2021 (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, MD, Principal investigator, Attikon University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03452124
- Sponsor's protocol ID
- IQOS-ATTIKON
- Status last verified
- Apr 2020
- First submitted
- 25 Feb 2018
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ikonomidis I, Vlastos D, Kostelli G, Kourea K, Katogiannis K, Tsoumani M, Parissis J, Andreadou I, Alexopoulos D. Differential effects of heat-not-burn and conventional cigarettes on coronary flow, myocardial and vascular function. Sci Rep. 2021 Jun 3;11(1):11808. doi: 10.1038/s41598-021-91245-9.
PubMed 34083663
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of I Quit Ordinary Smoking on the Arterial Wall and Endothelial Glycocalyx Properties of Smokers
- ClinicalTrials.gov ID
- NCT03452124
- Acronym / sponsor ID
- IQOS-ATTIKON
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- 30 Mar 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 2 Mar 2018 (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.
I quit ordinary smoking (IQOS) is proposed as a bridge to smoking cessation. In this study the investigators will examine its effects on aortic elasticity, glycocalyx integrity, and exhaled carbon monoxide (CO) concentration, both acutely and after 1 month of use.
Detailed description
Two smokers 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 I quit ordinary smoking (IQOS) for 1 month.
In the acute phase all 60 smokers will undergo a "sham" smoking for 7 minutes. Afterwards all 60 smokers will be randomized to smoke either a normal cigarette or IQOS and the after 60 minute washout period these subjects will be crossed over to the altenate mode of smoking (IQOS or normal cigarette respectively).
After the completion of the acute phase all 60 smokers will start the use of IQOS for one month.
In the acute phase, measurements will be performed at baseline, after sham smoking and after smoking of the normal cigarette or IQOS. The chronic phase measurements will be performed 1 month after use IQOS. Thirty current smokers of similar age and sex will serve as controls and will have measurements at baseline and 1 month after baseline assessment.
In both phases the investigators 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 (PCs).
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 |
|---|---|---|
| IQOS | Active comparator | Device: I quit ordinary smoking (IQOS)I quit ordinary smoking (IQOS) assistes 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 (2 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 |
|---|---|---|
| I quit ordinary smoking (IQOS)I quit ordinary smoking (IQOS) assisted cessation program | Device | IQOS |
| Conventional cigaretteConventional cigarette smoking continuation | Other | Smoker control |
Primary outcome
Acute I quit ordinary smoking (IQOS) effects on pulse wave velocity
Time frame: 7 minutes
Acute I quit ordinary smoking (IQOS) effects on pulse wave velocity (PWV, m/s) using tonometry
Acute I quit ordinary smoking (IQOS) effects on Exhaled Carbon monoxide (CO)
Time frame: 7 minutes
CO concentration was measured the exhaled carbon as parts per million-ppm by the device Smokerlyzer, Covita, Bedfont, CA, USA). Participants were instructed not to smoke the night before and the morning before the CO measurements and to hold their breath for 10 sec before exhaling to the mouthpiece.
Acute I quit ordinary smoking (IQOS) effects on endothelial glycocalyx thickness
Time frame: 7 minutes
Acute I quit ordinary smoking (IQOS) effects on endothelial glycocalyx thickness as assessed by perfused boundary region (PBR, micrometers) of the sublinqual arterial microvessels
Chronic I quit ordinary smoking (IQOS) effects on pulse wave velocity
Time frame: 1 month
Chronic I quit ordinary smoking (IQOS) effects on pulse wave velocity (PWV, m/s) using tonometry
Chronic I quit ordinary smoking (IQOS) effects on endothelial glycocalyx thickness
Time frame: 1 month
Chronic I quit ordinary smoking (IQOS) effects on endothelial glycocalyx thickness as assessed by perfused boundary region (PBR, micrometers) of the sublinqual arterial microvessels
Chronic I quit ordinary smoking (IQOS) effects in left ventricular function
Time frame: 1 month
Left Ventricular function is assessed by Global Longitudinal Strain by speckle tracking echocardiography
Chronic I quit ordinary smoking (IQOS) effects on endothelial function
Time frame: 1 month
Endothelial function was assessed by measuring coronary flow reserve of Left anterior descending artery. Coronary flow reserve was estimated by Doppler echocardiography as the ratio of coranary flow velocity after bolus intravenous adenosine infusion to coronary flow velocity at rest.
Chronic I quit ordinary smoking (IQOS) effects on endothelial function
Time frame: 1 month
Endothelial function was assessed by measuring Flow Mediated Vasodilation (FMD) using sonography. During a FMD test, vasodilation occurs following an acute increase in blood flow, typically induced via circulatory arrest in the arm (supra-systolic cuff occlusion) for a period of time. FMD is the percent of increase in brachial artery diameter after occlusion.
Chronic I quit ordinary smoking (IQOS) effects on Exhaled Carbon monoxide (CO)
Time frame: 1 month
CO concentration was measured the exhaled carbon as parts per million-ppm by the device Smokerlyzer, Covita, Bedfont, CA, USA). Participants were instructed not to smoke the night before and the morning before the CO measurements and to hold their breath for 10 sec before exhaling to the mouthpiece.
4 secondary outcomes
Acute I quit ordinary smoking (IQOS) effects on platelet activation.
Time frame: 7 minutes
Chronic I quit ordinary smoking (IQOS) effects on myocardial work.
Time frame: 1 month
Chronic I quit ordinary smoking (IQOS) effects on arterial stiffness.
Time frame: 1 month
Chronic I quit ordinary smoking (IQOS) effects on platelet activation.
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Derived from this study: PubMed 34083663Ikonomidis I, Vlastos D, Kostelli G, Kourea K, Katogiannis K, Tsoumani M, Parissis J, Andreadou I, Alexopoulos D. Differential effects of heat-not-burn and conventional cigarettes on coronary flow, myocardial and vascular function. Sci Rep. 2021 Jun 3;11(1):11808. doi: 10.1038/s41598-021-91245-9.
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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, MD principal investigator
Attikon University General 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 I quit ordinary smoking (IQOS) 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 2 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 24 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, MD (00302105832187, ignoik@otenet.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute I quit ordinary smoking (IQOS) effects on pulse wave velocity (time frame: 7 minutes). The study lists 9 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 NCT03452124, 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 24 Apr 2020.