E-Cigarette Effects on Markers of Cardiovascular and Pulmonary Disease

University of Wisconsin (UW)

Status: Completed

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

Treatments: Behavioral: E-Cigarettes; Behavioral: Cigarettes

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03863509

1R01HL139331-01 (U.S. NIH Grant/Contract)

SMPH\MEDICINE\CARDIOLOGY (Other Identifier)

2017-1090

Protocol Version 4/26/2021 (Other Identifier)

A534225 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 450 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

450 participants in 3 patient groups

Exclusive Smokers

Description:

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

Treatment:

Behavioral: Cigarettes

Exclusive E-Cig users

Description:

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

Treatment:

Behavioral: E-Cigarettes

Never users

Description:

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