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Effect of Smoking Reduction on Endothelial Glucocalyx and Vascular Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02307045
Recruitment Status : Unknown
Verified April 2020 by Ignatios Ikonomidis, University of Athens.
Recruitment status was:  Active, not recruiting
First Posted : December 3, 2014
Last Update Posted : April 3, 2020
Sponsor:
Information provided by (Responsible Party):
Ignatios Ikonomidis, University of Athens

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

Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: Varenicline Drug: nicotine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Effect of Smoking Reduction on Endothelial Glucocalyx and Arterial Wall Properites During Medically-aided Smoking Cessation Program.
Actual Study Start Date : December 3, 2014
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Nicorette (nicotine)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Smokers

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02307045


Locations
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Greece
''Attikon'' University General Hospital
Athens, Attiki, Greece, 12462
Sponsors and Collaborators
University of Athens
Investigators
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Principal Investigator: Ignatios Ikonomidis, MD 2nd Cardiology Department, University of Athens, Greece
Principal Investigator: Kalliroi Kourea, MD 2nd Cardiology Department, University of Athens, Greece
Principal Investigator: George Pavlidis, MD 2nd Cardiology Department, University of Athens, Greece
Principal Investigator: Margarita Marinou, MD 2nd Cardiology Department, University of Athens, Greece
Principal Investigator: John Lekakis, MD 2nd Cardiology Department, University of Athens, Greece
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ignatios Ikonomidis, Assistant Professor in Cardiology, University of Athens
ClinicalTrials.gov Identifier: NCT02307045    
Other Study ID Numbers: SMOKING-VAR-NIC-ATTIKON
First Posted: December 3, 2014    Key Record Dates
Last Update Posted: April 3, 2020
Last Verified: April 2020
Keywords provided by Ignatios Ikonomidis, University of Athens:
Arterial stiffness
Endothelial Glycocalyx
Additional relevant MeSH terms:
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Nicotine
Varenicline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action