Effect of Smoking Reduction on Endothelial Glucocalyx and Vascular Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-03

Study Completion Date

2020-12-31

Brief Summary

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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

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Detailed Description

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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

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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varenicline

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

Group Type ACTIVE_COMPARATOR

Varenicline

Intervention Type DRUG

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

nicotine

Nicotine replacement therapy with transdermal patches and/or chewing gums

Group Type ACTIVE_COMPARATOR

nicotine

Intervention Type DRUG

Nicotine replacement therapy with transdermal patches and/or chewing gums

Interventions

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Varenicline

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

Intervention Type DRUG

nicotine

Nicotine replacement therapy with transdermal patches and/or chewing gums

Intervention Type DRUG

Other Intervention Names

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Champix (varenicline) Nicorette (nicotine)

Eligibility Criteria

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Inclusion Criteria

* Smokers

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Ignatios Ikonomidis

Assistant Professor in Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR