Article Text
Abstract
Introduction Tobacco use leads to increased mortality, the majority of which is attributed to cardiovascular disease. Despite this knowledge, the early cardiovascular impact of tobacco product use is not well understood. Tobacco use increases exposure to harmful and potentially harmful constituents including volatile organic compounds (VOCs) such as acrolein and crotonaldehyde, which may contribute to cardiovascular risk. The link between exposure patterns, risk profiles and demographic distribution of tobacco product users, particularly users of new and emerging products, are not well known. Therefore, we designed the Cardiovascular Injury due to Tobacco Use (CITU) study to assess population characteristics, demographic features, exposure patterns and cardiovascular risk in relation to tobacco.
Methods and analysis We present the design and methodology of the CITU study, a cross-sectional observational tobacco study conducted in Boston, Massachusetts and Louisville, Kentucky starting in 2014. Healthy participants 21–45 years of age who use tobacco products, including electronic nicotine devices, or who never used tobacco are being recruited. The study aims to recruit an evenly split cohort of African-Americans and Caucasians, that is, sex balanced for evaluation of self-reported tobacco exposure, VOC exposure and tobacco-induced injury profiling. Detailed information about participant’s demographics, health status and lifestyle is also collected.
Ethics and dissemination The study protocol was approved institutional review boards at both participating universities. All study protocols will protect participant confidentiality. Results from the study will be disseminated via peer-reviewed journals and presented at scientific conferences.
- smoking
- tobacco
- electronic cigarette
- cardiovascular risk
- vascular injury
- cigarettes
This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
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Footnotes
Contributors RJK: study design, study recruitment, study visits, statistical analysis and manuscript preparation. JLF: study recruitment, study visits, manuscript preparation and editing. DWR: statistical analysis, manuscript preparation and editing. TO: biomarker measurements, manuscript preparation and editing. JLN: study recruitment and study visits. MH: study recruitment and study visits. PL: volatileorganic compound measurements and manuscript preparation. AB: study design, study funding and manuscript editing. APD: human subject assessment planning, manuscript preparation and editing. NMH: study design, study funding, vascular core, manuscript preparation and editing.
Funding This work was supported by the National Institutes of Health and the FDA Center for Tobacco Products (CTP) grant number P50HL120163.
Disclaimer The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH or the Food and Drug Administration.
Competing interests None declared.
Patient consent Not required.
Ethics approval The CITU study was approved at each institution by their institutional review board (BU #H-32613 and UofL #13.0590).
Provenance and peer review Not commissioned; externally peer reviewed.