Effect of Smoking Reduction on Endothelial Glucocalyx and Vascular Function

April 1, 2020 updated by: Ignatios Ikonomidis, University of Athens

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Attiki
      • Athens, Attiki, Greece, 12462
        • ''Attikon'' University General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Smokers

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: varenicline
Stimulation of nicotinic receptors by varenicline (Champix) 1,0 mg po
Drug: Varenicline
Stimulation of nicotinic receptors by varenicline (Champix) 1,0 mg po
Other Names:
  • Champix (varenicline)
Active Comparator: nicotine
Nicotine replacement therapy with transdermal patches and/or chewing gums
Drug: nicotine
Nicotine replacement therapy with transdermal patches and/or chewing gums
Other Names:
  • Nicorette (nicotine)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in endothelial function between baseline and during medically-aided smoking cessation program.
Time Frame: 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.
Baseline, 1 month, 3 months, 6 months and 12 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in a composite of markers of vascular function between baseline and during medically-aided smoking cessation program.
Time Frame: 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.
Baseline, 1 month, 3 months, 6 months and 12 months.
Follow up for cardiovascular events
Time Frame: 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
baseline , ten years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Athens

Investigators

  • Principal Investigator: Kalliroi Kourea, MD, 2nd Cardiology Department, University of Athens, Greece
  • Principal Investigator: Margarita Marinou, MD, 2nd Cardiology Department, University of Athens, Greece

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2014

Primary Completion (Anticipated)

November 30, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

December 1, 2014

First Submitted That Met QC Criteria

December 1, 2014

First Posted (Estimate)

December 3, 2014

Study Record Updates

Last Update Posted (Actual)

April 3, 2020

Last Update Submitted That Met QC Criteria

April 1, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMOKING-VAR-NIC-ATTIKON

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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