Clinical trial NCT02564289: Cardiovascular Effects of Chronic Snus Use
Official title: Cardiovascular Effects of Chronic Snus Use
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vascular Complications
Vascular Stiffness
Tobacco Dependence
Keywords: microvesicles, microparticles
Plethysmography
Snus
Arterial Stiffness
EPC
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2015-09-30
Enrollment: 50
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 25 healthy non-smoking males with regular snus consumption and 25 healthy non-smoking and non-snus using. Healthy volunteers were recruited in Umeå and surrounding communities.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Venous occlusion plethysmography
timeFrame: 1 day
Secondary outcomes:
measure: Circulating microvesicles
timeFrame: 1 day
measure: Endothelial progenitor cells
timeFrame: 1 day
measure: Arterial Stiffness
timeFrame: 1 day
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Dept of Medicine, Lung and Allergy section, University Hospital
state: Västerbotten
Study officials:
affiliation: Umeå University
name: Jenny A Bosson, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hergens MP, Alfredsson L, Bolinder G, Lambe M, Pershagen G, Ye W. Long-term use of Swedish moist snuff and the risk of myocardial infarction amongst men. J Intern Med. 2007 Sep;262(3):351-9. doi: 10.1111/j.1365-2796.2007.01816.x.
citation: Bolinder G, Alfredsson L, Englund A, de Faire U. Smokeless tobacco use and increased cardiovascular mortality among Swedish construction workers. Am J Public Health. 1994 Mar;84(3):399-404. doi: 10.2105/ajph.84.3.399.
citation: Rohani M, Agewall S. Oral snuff impairs endothelial function in healthy snuff users. J Intern Med. 2004 Mar;255(3):379-83. doi: 10.1046/j.1365-2796.2003.01279.x.
citation: Boffetta P, Straif K. Use of smokeless tobacco and risk of myocardial infarction and stroke: systematic review with meta-analysis. BMJ. 2009 Aug 18;339:b3060. doi: 10.1136/bmj.b3060.
citation: Arefalk G, Hambraeus K, Lind L, Michaelsson K, Lindahl B, Sundstrom J. Discontinuation of smokeless tobacco and mortality risk after myocardial infarction. Circulation. 2014 Jul 22;130(4):325-32. doi: 10.1161/CIRCULATIONAHA.113.007252. Epub 2014 Jun 23.
citation: Arefalk G, Hergens MP, Ingelsson E, Arnlov J, Michaelsson K, Lind L, Ye W, Nyren O, Lambe M, Sundstrom J. Smokeless tobacco (snus) and risk of heart failure: results from two Swedish cohorts. Eur J Prev Cardiol. 2012 Oct;19(5):1120-7. doi: 10.1177/1741826711420003. Epub 2011 Aug 9.
citation: Mobarrez F, Antoniewicz L, Bosson JA, Kuhl J, Pisetsky DS, Lundback M. The effects of smoking on levels of endothelial progenitor cells and microparticles in the blood of healthy volunteers. PLoS One. 2014 Feb 28;9(2):e90314. doi: 10.1371/journal.pone.0090314. eCollection 2014.