Clinical trial NCT02307045: Effect of Smoking Reduction on Endothelial Glucocalyx and Vascular Function
Official title: Effect of Smoking Reduction on Endothelial Glucocalyx and Arterial Wall Properites During Medically-aided Smoking Cessation Program.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Smoking Cessation
Keywords: Arterial stiffness
Endothelial Glycocalyx
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2014-12-03
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

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.

Eligibility criteria: Inclusion Criteria:

* Smokers

Exclusion Criteria:

* Coronary artery disease
* Heart failure
* Diabetes mellitus
* Dyslipidemia

Primary outcomes:
measure: Changes in endothelial function between baseline and during medically-aided smoking cessation program.
timeFrame: Baseline, 1 month, 3 months, 6 months and 12 months.
Secondary outcomes:
measure: Changes in a composite of markers of vascular function between baseline and during medically-aided smoking cessation program.
timeFrame: Baseline, 1 month, 3 months, 6 months and 12 months.
measure: Follow up for cardiovascular events
timeFrame: baseline , ten years
Other outcomes:
Locations:
city: Athens
country: Greece
facility: ''Attikon'' University General Hospital
state: Attiki
Study officials:
affiliation: 2nd Cardiology Department, University of Athens, Greece
name: Ignatios Ikonomidis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 2nd Cardiology Department, University of Athens, Greece
name: Kalliroi Kourea, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 2nd Cardiology Department, University of Athens, Greece
name: George Pavlidis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 2nd Cardiology Department, University of Athens, Greece
name: Margarita Marinou, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 2nd Cardiology Department, University of Athens, Greece
name: John Lekakis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.