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Status unknownNCT02307045Updated Apr 3, 2020

Effect of Smoking Reduction on Endothelial Glucocalyx and Vascular Function

A Phase 4 interventional study of Varenicline and nicotine in Smoking Cessation, sponsored by University of Athens. Status unknown at 1 site in Greece. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-03.

Sponsored by University of Athens · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Apr 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The integrity of endothelial glucocalyx plays a vital role in vascular permeability and inflammation. Smoking cessation is related with improved vascular function and is a key component of secondary cardiovascular prevention. Pharmacotherapy is a standard component of evidence based smoking cessation treatment. This study was designed to determine the effects medically-aided smoking cessation on glucocalyx thickness and arterial elasticity smoking cessation programs

Read the detailed description

The investigators will examine smokers without cardiovascular disease treated with transdermal nicotine patches and/or varenicline at before, 4, 12, 24 and 48 weeks after treatment during validated smoking cessation program. The investigators will measure changes between baseline and 4,12,24, and 48 weeks after treatment of :

  1. exhaled carbon monoxide (CO, ppm) and self-reported number of cigarretes/day
  2. carotid-femoral pulse wave velocity (PWVc m/sec-Complior SP ALAM) and augmentation index (AI %-Arteriograph,TensioMed)
  3. perfused boundary region (PBR) of the sublingual arterial microvessels (ranged from 5-25 micrometers) using Sideview Darkfield imaging (Microscan, Glycocheck). The PBR in microvessels is the cell-poor layer which results from the phase separation between the flowing red blood cells (RBC) and plasma. The PBR includes the most luminal part of glycocalyx that does allow cell penetration. Increased PBR is considered an accurate index of reduced endothelial glucocalyx thickness because of a for deeper penetration of the RBC in the glucocalyx
  4. oxidative stress, thrombosis and inflammatory biomarkers in blood samples.

Non smokers of similar age and sex will serve as controls.

02

Conditions studied

  • Smoking Cessation

Keywords

  • Arterial stiffness
  • Endothelial Glycocalyx
03

In context

Lead sponsor

University of Athens is the lead sponsor of 133 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Smokers

Exclusion criteria

Exclusion Criteria:

  • Coronary artery disease
  • Heart failure
  • Diabetes mellitus
  • Dyslipidemia
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
600 participants (estimated)

Study arms

  • Active comparator
    varenicline

    Stimulation of nicotinic receptors by varenicline (Champix) 1,0 mg po

    Drug: Varenicline

  • Active comparator
    nicotine

    Nicotine replacement therapy with transdermal patches and/or chewing gums

    Drug: nicotine

Interventions

  • DrugVarenicline

    Stimulation of nicotinic receptors by varenicline (Champix) 1,0 mg po

    Also known as: Champix (varenicline)

  • Drugnicotine

    Nicotine replacement therapy with transdermal patches and/or chewing gums

    Also known as: Nicorette (nicotine)

06

What researchers measure

Primary outcomes

  1. Changes in endothelial function between baseline and during medically-aided smoking cessation program.

    Changes in endothelial function between baseline and during medically-aided smoking cessation program as assessed by endothelial glycocalyx thickness.

    Time frame: Baseline, 1 month, 3 months, 6 months and 12 months.

Secondary outcomes

  1. Changes in a composite of markers of vascular function between baseline and during medically-aided smoking cessation program.

    Changes in vascular function between baseline and during medically-aided as assessed by a composite of pulse wave velocity, augmentation index and central aortic blood pressure.

    Time frame: Baseline, 1 month, 3 months, 6 months and 12 months.

  2. Follow up for cardiovascular events

    Association of endothelial glycocalyx as assessed by perfused boundary region (μm) with adverse cardiac events (composite of death, myocardial infarction, stroke , hospitalization for heart failure) during ten year follow -up in smokers and non-smoker subjects

    Time frame: baseline , ten years

07

Study locations

1 site
  • ''Attikon'' University General Hospital
    Athens, Attiki 12462, Greece
08

References and documents

Publications

  • Ikonomidis I, Marinou M, Vlastos D, Kourea K, Andreadou I, Liarakos N, Triantafyllidi H, Pavlidis G, Tsougos E, Parissis J, Lekakis J. Effects of varenicline and nicotine replacement therapy on arterial elasticity, endothelial glycocalyx and oxidative stress during a 3-month smoking cessation program. Atherosclerosis. 2017 Jul;262:123-130. doi: 10.1016/j.atherosclerosis.2017.05.012. Epub 2017 May 13. PubMed 28549278 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02307045
Lead sponsor
University of Athens
Responsible party
Ignatios Ikonomidis (Assistant Professor in Cardiology, University of Athens) — Principal investigator
First posted
Dec 3, 2014
Start date
Dec 3, 2014
Primary completion
Nov 30, 2020 (estimated)
Completion
Dec 2020 (estimated)
Last update
Apr 3, 2020

Study contacts

Ignatios Ikonomidis, MD
principal investigator · 2nd Cardiology Department, University of Athens, Greece
Kalliroi Kourea, MD
principal investigator · 2nd Cardiology Department, University of Athens, Greece
George Pavlidis, MD
principal investigator · 2nd Cardiology Department, University of Athens, Greece
Margarita Marinou, MD
principal investigator · 2nd Cardiology Department, University of Athens, Greece
John Lekakis, MD
principal investigator · 2nd Cardiology Department, University of Athens, Greece

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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