Vascular ComplicationsCHROSNCT02564289
Cardiovascular Effects of Chronic Snus Use
An observational study of Vascular Complications and Vascular Stiffness, run by Umeå University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 30 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Vascular Complications, Vascular Stiffness, Tobacco Dependence
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2015to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Normal clinical examination
- Normal ECG
- Normal routine blood test including serum lipids and HbA1C
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dept of Medicine, Lung and Allergy section, University Hospital
Umeå, Västerbotten County
About this study
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.
Read the 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.
- Keywords
- microvesicles, microparticles, Plethysmography, Snus, Arterial Stiffness, EPC
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Chronic snus users | Healthy subjects that used snus for more than 15 years. | |
| Healthy Controls | Healthy subjects that are never-users of snus. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (3)
Circulating microvesicles
Blood sample, expressed in 10^6MVs/L
Measured: 1 day
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.
Measured: 1 day
Arterial Stiffness
PWA, PWV. Expressed as Pulse wave velocity (m/s) och augmentation index adjusted for pulse 75 (%).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionFeb 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Vascular ComplicationsStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jenny Bosson, Umeå University
- Investigators
- Jenny A Bosson, MD,PhD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02564289
- Sponsor's protocol ID
- 2015/70-31
- Acronym
- CHROS
- Status last verified
- Mar 2016
- First submitted
- 29 Sep 2015
- Last updated
- 21 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 17697156Bolinder 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.
PubMed 8129055Rohani 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.
PubMed 14871462Boffetta 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.
PubMed 19690343Arefalk 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.
PubMed 24958793Arefalk 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.
PubMed 21828223Mobarrez 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.
PubMed 24587320
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Effects of Chronic Snus Use
- ClinicalTrials.gov ID
- NCT02564289
- Acronym / sponsor ID
- CHROS / 2015/70-31
- Keywords
- microvesicles, microparticles, Plethysmography, Snus, Arterial Stiffness, EPC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 30 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Chronic snus users | – | –Healthy subjects that used snus for more than 15 years. |
| Healthy Controls | – | –Healthy subjects that are never-users of snus. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Normal clinical examination
- Normal ECG
- Normal routine blood test including serum lipids and HbA1C
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Venous occlusion plethysmography
Time frame: 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.
3 secondary outcomes
Circulating microvesicles
Time frame: 1 day
Endothelial progenitor cells
Time frame: 1 day
Arterial Stiffness
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2016.
- Background: PubMed 17697156Hergens 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.
- Background: PubMed 8129055Bolinder 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.
- Background: PubMed 14871462Rohani 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.
- Background: PubMed 19690343Boffetta 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.
- Background: PubMed 24958793Arefalk 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.
- Background: PubMed 21828223Arefalk 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.
- Background: PubMed 24587320Mobarrez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenny A Bosson, MD,PhD principal investigator
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Complications and Vascular Stiffness, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Venous occlusion plethysmography (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02564289, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2016.