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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
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 :
Non smokers of similar age and sex will serve as controls.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| varenicline | Active Comparator | Stimulation of nicotinic receptors by varenicline (Champix) 1,0 mg po |
|
| nicotine | Active Comparator | Nicotine replacement therapy with transdermal patches and/or chewing gums |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varenicline | Drug | Stimulation of nicotinic receptors by varenicline (Champix) 1,0 mg po |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ''Attikon'' University General Hospital | Athens | Attica | 12462 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28549278 | Derived | Ikonomidis I, Marinou M, Vlastos D, Kourea K, Andreadou I, Liarakos N, Triantafyllidi H, Pavlidis G, Tsougos E, Parissis J, Lekakis J. Effects of varenicline and nicotine replacement therapy on arterial elasticity, endothelial glycocalyx and oxidative stress during a 3-month smoking cessation program. Atherosclerosis. 2017 Jul;262:123-130. doi: 10.1016/j.atherosclerosis.2017.05.012. Epub 2017 May 13. |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000068580 | Varenicline |
| D009538 | Nicotine |
| D000074164 | Nicotine Chewing Gum |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| nicotine | Drug | Nicotine replacement therapy with transdermal patches and/or chewing gums |
|
|
| 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 |
| D011810 | Quinoxalines |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D002638 | Chewing Gum |
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D061485 | Tobacco Use Cessation Devices |
| D013812 | Therapeutics |
| D002182 | Candy |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |