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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02564289
Other study ID # 2015/70-31
Secondary ID
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


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
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