Smoking Cessation
Conditions
Keywords
Arterial stiffness, Endothelial Glycocalyx
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.
Interventions
DRUGVarenicline
Stimulation of nicotinic receptors by varenicline (Champix) 1,0 mg po
DRUGnicotine
Nicotine replacement therapy with transdermal patches and/or chewing gums
Sponsors
University of Athens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Smokers
Exclusion criteria
* Coronary artery disease * Heart failure * Diabetes mellitus * Dyslipidemia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in endothelial function between baseline and during medically-aided smoking cessation program. | Baseline, 1 month, 3 months, 6 months and 12 months. | Changes in endothelial function between baseline and during medically-aided smoking cessation program as assessed by endothelial glycocalyx thickness. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in a composite of markers of vascular function between baseline and during medically-aided smoking cessation program. | Baseline, 1 month, 3 months, 6 months and 12 months. | 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. |
| Follow up for cardiovascular events | baseline , ten years | 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 |
Countries
Greece
Outcome results
None listed