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

NCT03039920 | Unknown

• 1 other identifier: 698/11-3-15
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (6)

• Acute electronic cigarette vaping effects on arterial stiffness.

  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.

  7 minutes

• Acute electronic cigarette vaping effects on endothelial integrity.

  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).

  7 minutes

• Chronic electronic cigarette vaping effects on arterial stiffness.

  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.

  1 month

• Chronic electronic cigarette vaping effects on endothelial integrity.

  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).

  1 month

• Chronic electronic cigarette vaping effects on platelet aggregation.

  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

  1 month

• Chronic electronic cigarette vaping effects on high-shear stress-dependent platelet function.

  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.

  1 month

Study Arms (2)

Electronic cigarette with or without nicotine

ACTIVE COMPARATOR

Electronic cigarette assisted cessation program

Other: Electronic cigarette

Smoker control

ACTIVE COMPARATOR

Conventional cigarette smoking continuation

Other: Conventional cigarette

Interventions

Electronic cigarette OTHER

Smoking of electronic cigarette

Electronic cigarette with or without nicotine

Conventional cigarette OTHER

Smoking tobacco cigarette

Smoker control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Active conventional cigarette smoker

You may not qualify if:

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

Sponsors & Collaborators

• University of Athens: lead

Study Sites (1)

''Attikon'' University General Hospital

Athens, Attica, 12462, Greece

RECRUITING

Related Publications (1)

• 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. No abstract available.

  PMID: 29335291 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Ignatios Ikonomidis, Dr

  Attikon Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ignatios Ikonomidis, Dr

CONTACT

00306944805732; ignoik@otenet.gr

Dimitrios Vlastos, Dr

CONTACT

00306942446956; dimitrisbvr@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 28, 2017
• First Posted: February 1, 2017
• Study Start: January 31, 2017
• Primary Completion: December 1, 2021
• Study Completion: June 1, 2022
• Last Updated: April 6, 2020

Record last verified: 2020-04

Locations

GR (1)