Effect of Smoking Reduction on Endothelial Glucocalyx and Vascular Function

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02307045
• Other study ID #: SMOKING-VAR-NIC-ATTIKON
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: December 3, 2014
• Est. completion date: December 2020

Study information

• Verified date: April 2020
• Source: University of Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: December 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Smokers

Exclusion Criteria:

• Coronary artery disease

• Heart failure

• Diabetes mellitus

• Dyslipidemia

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• Varenicline
Stimulation of nicotinic receptors by varenicline (Champix) 1,0 mg po
• nicotine
Nicotine replacement therapy with transdermal patches and/or chewing gums

Locations

Country	Name	City	State
Greece	''Attikon'' University General Hospital	Athens	Attiki

Sponsors (1)

Lead Sponsor	Collaborator
University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 1 month, 3 months, 6 months and 12 months.
Secondary	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.	Baseline, 1 month, 3 months, 6 months and 12 months.
Secondary	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	baseline , ten years