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Cardiovascular Disease Biomarkers in Smokers and Moist Snuff Consumers

NCT01692353 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 168

Last updated 2016-02-17

No results posted yet for this study

Summary

This cross-sectional study was primarily a cardiovascular disease (CVD) study designed a) to compare selected CVD biomarker data between subjects who were long-term consumers of cigarettes or moist snuff and non-consumers of tobacco and b) to identify principal endpoints related to CVD risk that differed among the three tobacco-use cohorts. The following assessments provided the primary study endpoints for comparative analyses between the cohorts:

1. CVD-related physiological assessments: Flow-mediated dilation (FMD), carotid intima-media thickness (CIMT), ankle-brachial index (ABI), spirometry and expired carbon monoxide (ECO).
2. CVD-related biomarker assessments in blood and urine (biomarkers of tobacco effect).
3. Biomarkers of tobacco exposure in urine and blood.

Conditions

Interventions

OTHER

Subject's usual brand (UB) tobacco product

For SMK: UB of cigarettes; For MSC: UB of moist snuff

Sponsors & Collaborators

  • MDS Pharma Services

    collaborator INDUSTRY

  • Analytisch-biologisches Forschungslabor GmbH

    collaborator INDUSTRY

  • BioClinica, Inc.

    collaborator INDUSTRY

  • Pacific Biomarkers

    collaborator OTHER

  • Rules-Based Medicine, Inc.

    collaborator INDUSTRY

  • R.J. Reynolds Tobacco Company

    lead INDUSTRY

Principal Investigators

  • David L Heavner, MS · R.J. Reynolds Tobacco Company

  • Buddy G Brown, MS · R.J. Reynolds Tobacco Company

  • Bobbette A Jones, DrPH, CCRP · R.J. Reynolds Tobacco Company

Eligibility

Min Age
26 Years
Max Age
49 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-02-28
Completion
2009-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01692353 on ClinicalTrials.gov