Effect of Smoking Reduction on Endothelial Glucocalyx and Vascular Function

• Sponsor: University of Athens (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02307045
• Collaborator: (none)
• Enrollment: 600
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 72
• Patients Per Site Per Month: 8.3

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• Anticipated 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: Dec 3, 2014
• Anticipated Primary Completion Date: Nov 30, 2020
• Anticipated Study Completion Date: Dec 1, 2020

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Smokers

Exclusion Criteria:

• Coronary artery disease

• Heart failure

• Diabetes mellitus

• Dyslipidemia

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	''Attikon'' University General Hospital	Athens	Attiki	Greece	12462

Sponsors and Collaborators

• University of Athens

Investigators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Dec 3, 2014
• Last Update Posted: Apr 3, 2020
• Last Verified: Apr 1, 2020

• Keywords provided by Ignatios Ikonomidis, Assistant Professor in Cardiology, University of Athens: Arterial stiffness; Endothelial Glycocalyx
• Additional relevant MeSH terms: Nicotine; Varenicline

Study Results

No Results Posted as of Apr 3, 2020