Cardiovascular Effects of Chronic Snus Use

Tobacco Dependence Clinical Trial

— CHROS  

Official title:

Cardiovascular Effects of Chronic Snus Use

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02564289
• Other study ID #: 2015/70-31
• Status: Recruiting
• Phase: N/A
• First received: September 29, 2015
• Last updated: January 21, 2016
• Start date: September 2015
• Est. completion date: February 2016

Study information

• Verified date: January 2016
• Source: Umeå University
• Contact: Jenny A Bosson, MD, PhD
• Phone: 0046-90-7850000
• Email: jenny.bosson[@]umu.se
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Tobacco Dependence
• Vascular Complications
• Vascular Stiffness

Locations

Country	Name	City	State
Sweden	Dept of Medicine, Lung and Allergy section, University Hospital	Umeå	Västerbotten

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

References & Publications (7)

Arefalk G, Hambraeus K, Lind L, Michaëlsson K, Lindahl B, Sundström 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. — View Citation

Arefalk G, Hergens MP, Ingelsson E, Arnlöv J, Michaëlsson K, Lind L, Ye W, Nyrén O, Lambe M, Sundström 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. — View 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. Review. — View 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. — View 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. Erratum in: J Intern Med. 2007 Nov;262(5):590. — View Citation

Mobarrez F, Antoniewicz L, Bosson JA, Kuhl J, Pisetsky DS, Lundbäck 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. — View Citation

Rohani M, Agewall S. Oral snuff impairs endothelial function in healthy snuff users. J Intern Med. 2004 Mar;255(3):379-83. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Venous occlusion plethysmography	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.	1 day	No
Secondary	Circulating microvesicles	Blood sample, expressed in 10^6MVs/L	1 day	No
Secondary	Endothelial progenitor cells	Blood sample, measured as CD34+KDR+(KDR:vascular endothelial growth factor receptor 2) double positive cells, and results are presented as the number of EPC events.	1 day	No
Secondary	Arterial Stiffness	PWA, PWV. Expressed as Pulse wave velocity (m/s) och augmentation index adjusted for pulse 75 (%).	1 day	No