The Effects of I Quit Ordinary Smoking on the Arterial Wall and Endothelial Glycocalyx Properties of Smokers

April 21, 2020 updated by: Ignatios Ikonomidis, University of Athens
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Two smokers groups matched for age and sex will be assessed:

  1. a group of 30 current smokers with no diagnosed cardiovascular disease as the control group for chronic phase
  2. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Greece
    • Attiki
      • Athens, Attiki, Greece, 12462
        • Recruiting
        • "ATTIKON" University General Hospital
        • Contact:
          • Ignatios Ikonomidis, MD
          • Phone Number: 00302105832187

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Active conventional cigarette smoker

Exclusion Criteria:

  • Health condition adversely affected by smoking
  • History or presence of cardiovascular disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Smoker control
Conventional cigarette smoking continuation
Other: Conventional cigarette
Conventional cigarette smoking continuation
Active Comparator: IQOS
I quit ordinary smoking (IQOS) assistes cessation program
Device: I quit ordinary smoking (IQOS)
I quit ordinary smoking (IQOS) assisted cessation program

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
7 minutes
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.
7 minutes
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
7 minutes
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
1 month
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
1 month
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
1 month
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.
1 month
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.
1 month
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.
1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acute I quit ordinary smoking (IQOS) effects on platelet activation.
Time Frame: 7 minutes
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.
7 minutes
Chronic I quit ordinary smoking (IQOS) effects on myocardial work.
Time Frame: 1 month
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)].
1 month
Chronic I quit ordinary smoking (IQOS) effects on arterial stiffness.
Time Frame: 1 month
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.
1 month
Chronic I quit ordinary smoking (IQOS) effects on platelet activation.
Time Frame: 1 month
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.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Athens

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ignatios Ikonomidis, MD, Attikon University General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IQOS-ATTIKON

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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