E-Cigarette Effects on Markers of Cardiovascular and Pulmonary Disease

NCT ID: NCT03863509

Last Updated: 2023-08-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 450 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-05
• Study Completion Date: 2022-03-09

Brief Summary

This study is designed to enhance the understanding of the possible health effects of e-cigarette use by relating the acute and long-term use of e-cigarettes and conventional cigarettes ("products") to well-validated cardiovascular and pulmonary disease biomarkers. Participants will be enrolled in 3 groups: exclusive e-cigarette users, exclusive cigarette smokers, and a control group of never-users. Participants can expect up to 4 weeks of study participation.

Detailed Description

E-cigarette use is increasing rapidly in the United States, especially amongst youth, underscoring the vital need to improve understanding of its health risks. Relevant data could inform policy, guide public health and clinical intervention efforts, and inform individuals who might use or who are using this product. This research will significantly enhance the understanding of the possible health effects of e-cigarette use by relating the acute and long-term use of e-cigarettes and conventional cigarettes ("products") to well-validated cardiovascular and pulmonary disease biomarkers. 3 different "use-groups" of participants will be enrolled: exclusive e-cigarette users (n=165), exclusive cigarette smokers (n=165), and a "control" group of never-users (n=110). These groups reflect the primary decisions that people can make regarding their future tobacco use: to continue to smoke cigarettes, to switch to e-cigarettes, or to avoid tobacco use entirely. It is essential that smokers and health care providers have accurate information on the health effect of these choices.

[Additionally, 100 participants will be invited to be part of an epigenetics sub-study (50 E-cig users, 25 smokers and 25 controls), prior to smoking, an additional 16 ml of blood will be collected in Vacutainer cell separation tubes for peripheral blood monocyte (PBMC) Isolation containing sodium citrate.]

Product use will be related to well-validated biomarkers that sensitively and reproducibly reflect mechanisms, injury, and/or future risk related to cardiovascular or pulmonary disease. Biomarkers will be related to: 1) acute product use in the laboratory (exposure challenges), 2) lifetime history of product use, and/or 3) real-time measures of product use in participants' daily lives. The primary cardiovascular biomarkers are brachial artery flow-mediated dilation (a measure of endothelial function) and carotid intima-media thickness, a measure of subclinical arterial injury and atherosclerosis. The primary pulmonary disease biomarkers will be measures of lung volumes and flow rates (Forced Expiatory Volume exhaled in the first second (FEV1), Forced vital capacity (FVC), FEV1/FVC) obtained by spirometry. Treadmill exercise stress testing will be performed (to assess aerobic fitness), electrocardiography (to measure heart rate variability, HRV), and measure heart rate, blood pressure, lipids, HgbA1c, and inflammation/oxidation markers (leukocyte count, C-reactive protein, urinary F2 isoprostanes and exhaled nitric oxide). This research will show how product use-groups differ in response to acute product use and long-term use as they are related to key cardiovascular and pulmonary biomarkers. Objective measures of product use include exhaled CO and plasma nicotine/cotinine and urinary nicotine/cotinine concentrations. History of product use within use-groups will be related to biomarker status.

The proposed research will yield vital and comprehensive data regarding product use, subclinical arterial injury, atherosclerosis burden, arterial and pulmonary function, cardiac and aerobic fitness, cardiac autonomic regulation, systemic and pulmonary inflammation, and oxidative stress, as well as other key outcomes. These data will serve as a foundation for future longitudinal investigations of e-cigarette health effects and will inform public policy decisions, clinical intervention, and patient guidance regarding e-cigarettes.

Conditions

Tobacco Use; E-Cigarette Use; Cardiovascular Diseases; Pulmonary Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Exclusive Smokers

Smokes Daily; \>/= 5 cigarettes/day for last 6 months

Cigarettes

Intervention Type: BEHAVIORAL

smokes daily

Exclusive E-Cig users

E-cig usage \>/= 5 days/week for last 3 months

E-Cigarettes

Intervention Type: BEHAVIORAL

E-cigarette usage \>/= 5 days/week

Never users

\< 100 cigarettes in lifetime, none for \> 5 years; \< 3 E-cig usage in lifetime

No interventions assigned to this group

Interventions

Cigarettes

smokes daily

Intervention Type: BEHAVIORAL

E-Cigarettes

E-cigarette usage \>/= 5 days/week

Intervention Type: BEHAVIORAL

Other Intervention Names

E-cig; Vape

Eligibility Criteria

Inclusion Criteria

• able to read and write English
• no plans to quit smoking and/or e-cig use in the next month
• not using cigars/smokeless/snus tobacco >/= 1 time per week
• having a stable pattern of current product use
• able to walk at least 2 blocks without assistance or stopping
• Specific to Exclusive Smokers:

• smokes daily
• >/= 5 cigs/day for last 6 months
• < 3 uses E-cigs in lifetime
• >/= 5 ppm carbon monoxide (CO)
• Cotinine > 100 ng/ml
• Specific to Exclusive E-cig users:

• </= 2 days per month cigarette use for last 6 months
• >/= 5 days per week E-cig use for last 3 months
• </= 4 ppm CO
• Cotinine > 100 ng/ml
• Specific to Never-users

• < 100 cigarettes in a lifetime, none for > 5 years
• < 3 E-cig uses in a lifetime
• </= 4 ppm CO
• Cotinine < 100 ng/ml

Exclusion Criteria

• current use of a smoking cessation medication
• women who are pregnant or plan to get pregnant in the coming month
• women who might be pregnant
• incarcerated individuals
• history of sarcoidosis in past 5 years, or active interstitial lung/pulmonary fibrosis
• history of positive Coronavirus-19 test

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James H Stein, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin

Madison, Wisconsin, United States

Countries

United States

References

Tattersall MC, Hughey CM, Piasecki TM, Korcarz CE, Hansen KM, Ott NR, Sandbo N, Fiore MC, Baker TB, Stein JH. Cardiovascular and Pulmonary Responses to Acute Use of Electronic Nicotine Delivery Systems and Combustible Cigarettes in Long-Term Users. Chest. 2023 Sep;164(3):757-769. doi: 10.1016/j.chest.2023.03.047. Epub 2023 Apr 10.

Reference Type: RESULT

PMID: 37044158 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

https://doi.org/10.1016/j.chest.2023.03.047

link to full manuscript with published results for this trial

Other Identifiers

1R01HL139331-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Protocol Version 4/26/2021

Identifier Type: OTHER

Identifier Source: secondary_id

A534225

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH\MEDICINE\CARDIOLOGY

Identifier Type: OTHER

Identifier Source: secondary_id

2017-1090

Identifier Type: -

Identifier Source: org_study_id