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临床试验/NCT02564289
NCT02564289已完成不适用

Cardiovascular Effects of Chronic Snus Use

Umeå University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Venous occlusion plethysmography

研究概览

简要总结

The current study proposes to investigate the effects of chronic snus use on the blood vessels. Several cardiovascular endpoints are measured using various methods in healthy daily snus users as well as in healthy matched controls.

详细描述

The Swedish moist oral snuff known as "snus" has previously been found primarily in Scandinavia. In Sweden approximately 1 in 5 men are habitual users of snus. It is estimated that 3-4% of the female population are regular users. However, the last few years has seen a shift in the global tobacco industry towards finding novel ways of entering the smokeless tobacco (ST) markets. In the United States both Camel and Marlboro brands, among others, have launched an array of ST products similar to Swedish snus. Since its launch in 2007, the US snus market has continued to grow at an exponential rate and now sells approximately 50 million cans a year.

Smoking has been studied extensively and been undoubtedly linked to a range of detrimental health effects, including cardiovascular disease. As snus has until recently been available in a limited Scandinavian market, few experimental and epidemiological studies have been performed.

A recent meta-analysis found snus to be associated with heart failure and higher risk of fatal myocardial infarctions and stroke. Following myocardial infarction, discontinuation of snus use was associated with a 50% decreased risk of mortality.

With new emerging markets worldwide publicizing the product as a discrete and healthier alternative to cigarettes, it has become all the more imperative to study the health effects of this smokeless tobacco. Using well validated methods the investigators intend to study the possible effects of chronic snus use on vascular endothelial function, thrombosis, circulating microparticles in blood and arterial stiffness.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Normal clinical examination
  • Normal ECG
  • Normal routine blood test including serum lipids and HbA1C

排除标准

  • Any form of cardiovascular disease
  • Any form of systemic or chronic disorder like rheumatologic or metabolic diseases.
  • Active allergy within 4 weeks of the study
  • Symptoms of infection or inflammation within 4 weeks of the study

结局指标

主要结局

Venous occlusion plethysmography

时间窗: 1 day

Venous occlusion plethysmography is a semi-invasive method of estimating vascular function in which brachial forearm blood flow is measured. In combination with intra-arterial infusion of substances with vasodilatory effects (for example bradykinin, sodium nitroprusside and acetylcholine) this method is considered the "golden standard" for assessing endothelial function. Measurements are given in ml/100 ml tissue/min.

次要结局

  • Endothelial progenitor cells(1 day)
  • Circulating microvesicles(1 day)
  • Arterial Stiffness(1 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jenny Bosson

MD, PhD

Umeå University

研究点 (1)

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