E-Cigarette Effects on Markers of Cardiovascular and Pulmonary Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Smoking Cessation, Pulmonary |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/30/2019 |
| Start Date: | March 5, 2019 |
| End Date: | December 30, 2022 |
| Contact: | Claudia E Korcarz |
| Email: | ck4@medicine.wisc.edu |
| Phone: | 608-265-9947 |
E-Cigarette Effects on Markers of Cardiovascular and Pulmonary Disease Risk (Aka CLUES - Cardiac and LUng E-cig Smoking Study)
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 4 groups: exclusive e-cigarette users, exclusive cigarette
smokers, e-cigarette and cigarette users, and a control group of never-users. Participants
can expect up to 4 weeks of study participation.
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 4 groups: exclusive e-cigarette users, exclusive cigarette
smokers, e-cigarette and cigarette users, and a control group of never-users. Participants
can expect up to 4 weeks of study participation.
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=110), exclusive cigarette smokers (n=110),
dual product users (who both smoke and vape: n=110) 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, to use both
cigarettes and 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.
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 (FEV1, FVC,
FEV1/FVC, FEF25-75) 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.
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=110), exclusive cigarette smokers (n=110),
dual product users (who both smoke and vape: n=110) 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, to use both
cigarettes and 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.
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 (FEV1, FVC,
FEV1/FVC, FEF25-75) 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.
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:
-
- >/= 5 days per week E-cig use for last 3 months
-
- Cotinine > 100 ng/ml
- Specific to Dual users
- >/= 5 cigs/day for last 6 months
- >/= 5 days per week E-cig use for last 3 months
- >/= 5 ppm CO
- Continine > 100 ng/ml
- Specific to Never-users
- < 100 cigarettes in a lifetime, none for > 5 years
- < 3 E-cig uses in a lifetime
-
- Continine < 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
We found this trial at
1
site
Madison, Wisconsin 53792
(608) 263-2400
Principal Investigator: James H Stein, MD
Phone: 608-265-9947
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
Click here to add this to my saved trials
