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

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

Study Description

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)

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Contacts

Contact: Ignatios Ikonomidis, Dr; 00306944805732; ignoik@otenet.gr

Contact: Dimitrios Vlastos, Dr; 00306942446956; dimitrisbvr@hotmail.com

Locations

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

• Principal Investigator: Ignatios Ikonomidis, Dr; Attikon Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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
• Last Update Posted: April 6, 2020
• Last Verified: April 2020

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