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

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ClinicalTrials.gov Identifier: NCT03452124
Recruitment Status : Recruiting
First Posted : March 2, 2018
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Ignatios Ikonomidis, University of Athens

Brief 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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Device: I quit ordinary smoking (IQOS) Other: Conventional cigarette Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects of I Quit Ordinary Smoking on the Arterial Wall and Endothelial Glycocalyx Properties of Smokers
Actual Study Start Date : March 30, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Active Comparator: Smoker control
Conventional cigarette smoking continuation
Other: Conventional cigarette
Conventional cigarette smoking continuation




Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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.

  9. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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)].

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Active conventional cigarette smoker

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03452124


Contacts
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Contact: Ignatios Ikonomidis, MD 00302105832187 ignoik@otenet.gr
Contact: George Pavlidis, MD 00302105832187 geo_pavlidis@yahoo.gr

Locations
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Greece
"Attikon" University General Hospital Recruiting
Athens, Attiki, Greece, 12462
Contact: Ignatios Ikonomidis, MD    00302105832187      
Principal Investigator: Ignatios Ikonomidis, MD         
Sponsors and Collaborators
University of Athens
Investigators
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Principal Investigator: Ignatios Ikonomidis, MD Attikon University General Hospital
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Responsible Party: Ignatios Ikonomidis, Associate Professor, University of Athens
ClinicalTrials.gov Identifier: NCT03452124    
Other Study ID Numbers: IQOS-ATTIKON
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No