Effect of Smoking Reduction on Endothelial Glucocalyx and Arterial Wall Properites During Medically-aided Smoking Cessation Program.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Changes in endothelial function between baseline and during medically-aided smoking cessation program.
研究概览
简要总结
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
详细描述
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 :
- exhaled carbon monoxide (CO, ppm) and self-reported number of cigarretes/day
- carotid-femoral pulse wave velocity (PWVc m/sec-Complior SP ALAM) and augmentation index (AI %-Arteriograph,TensioMed)
- 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
- oxidative stress, thrombosis and inflammatory biomarkers in blood samples.
Non smokers of similar age and sex will serve as controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Coronary artery disease
- •Heart failure
- •Diabetes mellitus
- •Dyslipidemia
研究组 & 干预措施
varenicline
Stimulation of nicotinic receptors by varenicline (Champix) 1,0 mg po
干预措施: Varenicline (Drug)
nicotine
Nicotine replacement therapy with transdermal patches and/or chewing gums
干预措施: nicotine (Drug)
结局指标
主要结局
Changes in endothelial function between baseline and during medically-aided smoking cessation program.
时间窗: 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.
次要结局
- 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.)
- Follow up for cardiovascular events(baseline , ten years)
研究者
Ignatios Ikonomidis
Assistant Professor in Cardiology
University of Athens