Electronic Cigarette UseVAPECHECKNCT06610838
Effects of E-cigarette Use on Health
An observational study of Electronic Cigarette Use, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Electronic Cigarette Use
- What is being tested?
- Health Assessments
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2025to 30 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study 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.
Who may be able to join
- 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
- no serious CV, pulmonary, or other medical problems
- not currently pregnant
- no plans to stop vaping
Who cannot join
- 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
- incarceration
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UW Center for Tobacco Research and Intervention
Madison, Wisconsin, 53711
About this study
Official title: Longitudinal Effects of E-cigarette Use on Cardiovascular and Pulmonary Health
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.
Read the detailed description
Electronic nicotine delivery systems (ENDS) are used by millions of Americans, however, their long-term health effects are unknown. Although ENDS use delivers far lower levels of carcinogens than tobacco smoking, very little is known about whether ENDS use affects the risks of developing cardiovascular (CV) or pulmonary diseases, two of the most highly prevalent causes of morbidity and mortality in the United States. This research proposal will quantify the effects of long-term ENDS use on validated and novel biomarkers of CV and pulmonary disease and how they are influenced by use heaviness, age, body weight, and co-use of other products. This research also will shed additional light on long-term ENDS use patterns and ENDS dependence. The importance of this study does not rest upon demonstrating adverse effects of ENDS use.
The study team will recruit up to 400 long-term, stable users of ENDS and up to 200 age- and gender-matched control participants who do not use ENDS or combustible cigarettes. They will undergo comprehensive biomarker assessments over 36 months. Biomarkers assess CV and pulmonary health status and risk and include vital signs, blood samples for systemic inflammation and oxidative stress, lipids, and markers of insulin resistance and cardiometabolic health. Arterial structure changes will be assessed using carotid ultrasound. Sympathetic nervous system activation will be assessed by heart rate variability and arterial diameters. For pulmonary measures, the study team will obtain non-contrast quantitative computed tomography (CT) images to assess air trapping and texture-based measures of inflammation. The researcher also will perform spirometry. Integrated cardiopulmonary health will be assessed via treadmill stress testing. Other measures will include exhaled carbon monoxide, real-time measures of nicotine product use, nicotine dependence, and use of cannabis and alcohol. Biomarker status over time will be compared across groups and related to ENDS use heaviness, use of other products, and person factors (i.e., age, gender, race/ethnicity, weight, and smoking history). About 130 participants who were phenotyped from 2019-2021 will be included.
The Primary Aim is to determine relationships between ENDS use heaviness and changes in our CV and pulmonary health biomarkers over 3 years. Biomarker status across ENDS users and non-users over time will be compared and associations between biomarker status and ENDS use heaviness within the ENDS user group will be examined.
The Secondary Aim is to characterize changes in ENDS use patterns and dependence over time and to determine how these are related to biomarker status changes and how they are influenced by the person factors described above. The primary and secondary CV measures are changes in common carotid artery intima-media thickness (CCA IMT) and grayscale median (GSM). The primary and secondary pulmonary measures are the changes in the quantitative CT measures of air trapping and parenchymal texture. This proposal will produce the most informative evidence to date on how long-term ENDS use affects CV and pulmonary health and disease risk.
- Conditions
- Electronic Cigarette Use
- Being tested
- Health Assessments
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health AssessmentsOther
Participants 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.
| Study group | Role | What they receive |
|---|---|---|
| ENDS users | Long-term stable users of electronic nicotine delivery systems, 21 years of age or older, who do not use combustible (conventional) cigarettes Receives: Other: Health Assessments | |
| Non-users | Gender-matched control participants who do not use ENDS or combustible cigarettes Receives: Other: Health Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 3 years
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.
Measured: Baseline to 3 years
Secondary 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.
Measured: Baseline to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start6 Jan 2025
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electronic Cigarette UseStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Timothy Baker, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06610838
- Sponsor's protocol ID
- 2024-0684
- Other IDs
- 1R01HL175602-01, A534253, SMPH/MEDICINE/GEN INT MD, Protocol Version 10/23/25
- Acronym
- VAPECHECK
- Status last verified
- Dec 2025
- First submitted
- 19 Sep 2024
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the questionnaire and interview responses, the ecological momentary assessment (EMA) data, results of cardiovascular and pulmonary tests, and urine and blood test results will be preserved and shared to the Biologic Specimen and Data Repository (BioLINCC) in comma separated value (CSV) format.
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Effects of E-cigarette Use on Cardiovascular and Pulmonary Health
- ClinicalTrials.gov ID
- NCT06610838
- Acronym / sponsor ID
- VAPECHECK / 2024-0684
- Conditions
- Electronic Cigarette Use
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Electronic nicotine delivery systems (ENDS) are used by millions of Americans, however, their long-term health effects are unknown. Although ENDS use delivers far lower levels of carcinogens than tobacco smoking, very little is known about whether ENDS use affects the risks of developing cardiovascular (CV) or pulmonary diseases, two of the most highly prevalent causes of morbidity and mortality in the United States. This research proposal will quantify the effects of long-term ENDS use on validated and novel biomarkers of CV and pulmonary disease and how they are influenced by use heaviness, age, body weight, and co-use of other products. This research also will shed additional light on long-term ENDS use patterns and ENDS dependence. The importance of this study does not rest upon demonstrating adverse effects of ENDS use.
The study team will recruit up to 400 long-term, stable users of ENDS and up to 200 age- and gender-matched control participants who do not use ENDS or combustible cigarettes. They will undergo comprehensive biomarker assessments over 36 months. Biomarkers assess CV and pulmonary health status and risk and include vital signs, blood samples for systemic inflammation and oxidative stress, lipids, and markers of insulin resistance and cardiometabolic health. Arterial structure changes will be assessed using carotid ultrasound. Sympathetic nervous system activation will be assessed by heart rate variability and arterial diameters. For pulmonary measures, the study team will obtain non-contrast quantitative computed tomography (CT) images to assess air trapping and texture-based measures of inflammation. The researcher also will perform spirometry. Integrated cardiopulmonary health will be assessed via treadmill stress testing. Other measures will include exhaled carbon monoxide, real-time measures of nicotine product use, nicotine dependence, and use of cannabis and alcohol. Biomarker status over time will be compared across groups and related to ENDS use heaviness, use of other products, and person factors (i.e., age, gender, race/ethnicity, weight, and smoking history). About 130 participants who were phenotyped from 2019-2021 will be included.
The Primary Aim is to determine relationships between ENDS use heaviness and changes in our CV and pulmonary health biomarkers over 3 years. Biomarker status across ENDS users and non-users over time will be compared and associations between biomarker status and ENDS use heaviness within the ENDS user group will be examined.
The Secondary Aim is to characterize changes in ENDS use patterns and dependence over time and to determine how these are related to biomarker status changes and how they are influenced by the person factors described above. The primary and secondary CV measures are changes in common carotid artery intima-media thickness (CCA IMT) and grayscale median (GSM). The primary and secondary pulmonary measures are the changes in the quantitative CT measures of air trapping and parenchymal texture. This proposal will produce the most informative evidence to date on how long-term ENDS use affects CV and pulmonary health and disease risk.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ENDS users | – | Other: Health AssessmentsLong-term stable users of electronic nicotine delivery systems, 21 years of age or older, who do not use combustible (conventional) cigarettes |
| Non-users | – | Other: Health AssessmentsGender-matched control participants who do not use ENDS or combustible cigarettes |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (7 listed)
- 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
- no serious CV, pulmonary, or other medical problems
Key exclusion criteria (5 listed)
- 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
- incarceration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health AssessmentsParticipants 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. | Other | ENDS users, Non-users |
Primary outcome
Change in mean common carotid artery intima-media thickness (CCA-IMT)
Time frame: Baseline to 3 years
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.
Change in LAA-856
Time frame: Baseline to 3 years
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.
1 secondary outcome
Change in common carotid artery intima-media Grayscale Median (GSM)
Time frame: Baseline to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: Yes. All of the questionnaire and interview responses, the ecological momentary assessment (EMA) data, results of cardiovascular and pulmonary tests, and urine and blood test results will be preserved and shared to the Biologic Specimen and Data Repository (BioLINCC) in comma separated value (CSV) format.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Timothy Baker, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Electronic Cigarette Use, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James Stein, MD (608-262-2075, jhs@medicine.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean common carotid artery intima-media thickness (CCA-IMT) (time frame: Baseline to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.