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The Effects of Electronic Cigarette Smoking on the Arterial Wall and Endothelial Glycocalyx Properties of Smokers

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ClinicalTrials.gov Identifier: NCT03039920
Recruitment Status : Recruiting
First Posted : February 1, 2017
Last Update Posted : April 6, 2020
Sponsor:
Information provided by (Responsible Party):
Ignatios Ikonomidis, University of Athens

Brief 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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Other: Electronic cigarette Other: Conventional cigarette Not Applicable

Detailed Description:

Two smoker 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 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)

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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 Electronic Cigarette Smoking on the Arterial Wall and Endothelial Glycocalyx Properties of Smokers
Actual Study Start Date : January 31, 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Electronic cigarette with or without nicotine
Electronic cigarette assisted cessation program
Other: Electronic cigarette
Smoking of electronic cigarette

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




Primary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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).

  5. 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

  6. 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.



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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): NCT03039920


Contacts
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Contact: Ignatios Ikonomidis, Dr 00306944805732 ignoik@otenet.gr
Contact: Dimitrios Vlastos, Dr 00306942446956 dimitrisbvr@hotmail.com

Locations
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Greece
''Attikon'' University General Hospital Recruiting
Athens, Attiki, Greece, 12462
Contact: Ignatios Ikonomidis, MD    00302105831264      
Principal Investigator: Ignatios Ikonomidis, MD         
Sponsors and Collaborators
University of Athens
Investigators
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Principal Investigator: Ignatios Ikonomidis, Dr Attikon Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ignatios Ikonomidis, Assistant Professor, University of Athens
ClinicalTrials.gov Identifier: NCT03039920    
Other Study ID Numbers: 698/11-3-15
First Posted: February 1, 2017    Key Record Dates
Last Update Posted: April 6, 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