Effects of E-cigarette Use on Health
ConditionElectronic Cigarette Use
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorUniversity of Wisconsin, Madison
About this trial
Electronic nicotine delivery systems (ENDS) are used by millions of Americans, however their long-term health effects are unknown. This research proposal will quantify the effects of long-term ENDS use on validated and novel biomarkers of cardiovascular and pulmonary disease and how they are influenced by use heaviness, age, body weight, and co-use of other products. This study will produce the most informative evidence to date on how long-term ENDS use affects cardiovascular and pulmonary health.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
greater than or equal to 21 years of age
has vaped a nicotine e-cigarette product at least 2 days/week for most weeks for greater than or equal to 12 months
plans to remain in catchment area for greater than or equal to 3 years
smoked 5 or fewer tobacco cigarettes in the past 6 months
Disqualifiers
serious CV, pulmonary, or other medical problems (e.g., moderate or severe aortic stenosis, class III or IV heart failure, blood pressure greater than or equal to 160/100 mmHg, interstitial lung disease, sarcoidosis, Stage 3 or 4 cancer)
combusted or vaped cannabis use 3 days/week or more in the past 3 months
currently pregnant
not able to read an write English
Trial population
The participants enrolled will comprise a large group of exclusive ENDS users who do not use combusted cigarettes and who have used ENDS regularly for at least 1 year. ENDS participants must have vaped at least 2 days/week for greater than or equal to 12 months, smoke very infrequently, and have no plans to try to stop vaping in the foreseeable future. The comparison non-user group also will be gender-matched and comprise those who report no vaping or smoking in the past 6 months and less than 5 times in 2 years.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Health Assessments
Other interventionParticipants will complete the blood tests, questionnaires, cardiovascular tests, and pulmonary test at visits 1, 2, and 4. Non-Contrast Chest CT and cardiopulmonary treadmill (VO2 max) stress tests will occur at visits 1 and 4. Visit 3 will not include cardiovascular and pulmonary tests.
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: ENDS users1 intervention
Group B: Non-users1 intervention
Trial outcomes
Primary outcomes
1
Change in mean common carotid artery intima-media thickness (CCA-IMT)
Carotid ultrasound CCA-IMT measures the thickness of the carotid artery wall and is a measure of arterial injury. Rates of change vary by age, sex, and race, but less increase is associated with less cardiovascular disease risk.
Time frame
Baseline to 3 years2
Change in LAA-856
Quantitative computed tomography (CT) can measure LAA-856 \[percent of lung voxels less than -856 HU\], which describes air trapping. Less air trapping indicates less progression of obstructive ventilation in and risk of obstructive lung diseases.
Time frame
Baseline to 3 yearsSecondary outcomes
1
Change in common carotid artery intima-media Grayscale Median (GSM)
Changes in Parenchymal Texture will be in part measured with carotid GSM. Captured via ultrasound, images analyzed using LifeQ Medical Plaque Analysis Software for GSM.
Time frame
Baseline to 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Wisconsin, Madison
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov