Cardiovascular Effects of Chronic Snus Use (CHROS)

March 18, 2016 updated by: Jenny Bosson, Umeå University
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Västerbotten
      • Umeå, Västerbotten, Sweden
        • Dept of Medicine, Lung and Allergy section, University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Circulating microvesicles
Time Frame: 1 day
Blood sample, expressed in 10^6MVs/L
1 day
Endothelial progenitor cells
Time Frame: 1 day
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
Arterial Stiffness
Time Frame: 1 day
PWA, PWV. Expressed as Pulse wave velocity (m/s) och augmentation index adjusted for pulse 75 (%).
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Investigators

  • Principal Investigator: Jenny A Bosson, MD,PhD, Umeå University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

September 29, 2015

First Submitted That Met QC Criteria

September 29, 2015

First Posted (Estimate)

September 30, 2015

Study Record Updates

Last Update Posted (Estimate)

March 21, 2016

Last Update Submitted That Met QC Criteria

March 18, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/70-31

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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