NCT02307045

Effect of Smoking Reduction on Endothelial Glucocalyx and Vascular Function

Effect of Smoking Reduction on Endothelial Glucocalyx and Arterial Wall Properites During Medically-aided Smoking Cessation Program.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: University of Athens · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Smoking Cessation

Interventions

Type	Name	Description
DRUG	Varenicline	Stimulation of nicotinic receptors by varenicline (Champix) 1,0 mg po
DRUG	nicotine	Nicotine replacement therapy with transdermal patches and/or chewing gums

Timeline

• Start date: 2014-12-03
• Primary completion: 2020-11-30
• Completion: 2020-12-01
• First posted: 2014-12-03
• Last updated: 2020-04-03

Locations

1 site across 1 country: Greece