Electronic Cigarette Related Lung Damage
Conditions
Keywords
hyperpolarized xenon-129 MRI, cardiopulmonary stress test, lung damage, vaping, healthy young adult
Brief summary
A two-center, longitudinal assessment of 40 electronic cigarette users and 40 healthy controls at the initial visit and a follow-up visit 12 months later. This study will determine the impact of electronic cigarette use on pulmonary gas exchange capacity and then corroborate the Hyperpolarized Xenon MRI (HXeMRI) results with the cardiopulmonary stress test at the initial visit and a follow-up visit 12 months later.
Detailed description
Electronic cigarettes have been commercialized as a "less harmful" alternative to traditional cigarettes. Electronic cigarettes generate vapor from ingredients containing well-known toxic materials such as carbonyls, tobacco-specific N-nitrosamines, and heavy metals. Nonhuman studies show that Electronic cigarettes cause pulmonary epithelial, endothelial, and vascular dysfunction. Electronic cigarette use has also been associated with cardiac and pulmonary diseases, including severe respiratory failure. Our preliminary studies suggest that we can detect subtle early changes in healthy young e-cigarette users by hyperpolarized xenon-129 MR imaging. We anticipate the following results from the three primary analyses. First, there will be significantly impaired gas exchange in electronic cigarette users compared to healthy controls at the initial and follow-up visits. Second, gas exchange impairment in electronic cigarette users will increase after an additional 12 months of electronic cigarette use. Further, as a secondary analysis, we speculate that because electronic cigarette users exhaust their cardiopulmonary reserve at rest, they will have reduced physical fitness detectable by the 6-minute walk and Cardio-pulmonary exercise tests.
Interventions
Determine the impact of e-cigarette use on pulmonary gas exchange capacity in interstitial tissues and capillaries using hyperpolarized xenon-129 MRI.
DIAGNOSTIC_TESTCardiopulmonary Stress Test
Exercise stress test to evaluate cardiac and pulmonary fitness.
DIAGNOSTIC_TESTPulmonary Function Test
Standard clinic pulmonary function test to evaluate lung function
DIAGNOSTIC_TESTChest CT
Clinical standard chest computer tomography to evaluate any lung tissue scars or air movement.
Sponsors
Y. Michael Shim, MD
Duke University
George Mason University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
40 Participants who are healthy with less than 6 months of smoking history and 40 electronic cigarette users with more than 6 months of electronic cigarette usage. Subjects will be recruited and consented at the University of Virginia and Duke University.
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
1. Ages between 18 and 35 years old. 2. At their baseline health 3. Ability to understand a written informed consent form and comply with the requirements of the study. 4. Exclusive long-term, recent, and greater than six months continuous e-cigarette use with greater than three days a week frequency. 5. Users of "closed-container" and "pre-packaged" electronic cigarette juices that must contain nicotine. 6. Healthy subjects must be at baseline normal spirometry with or without bronchodilator, plethysmograph lung volume, DLCO, and 6-minute walk by ATS/ERS with Global Lung Initiative Reference. (PFT will be completed during a screening visit); Ecigarette users can have normal spirometry (FEV1/FVC\>70) or abnormal spirometry (FEV1/FVC 26-70) \-
Exclusion criteria
1. History of any other lung disease 2. History of brain diseases including stroke (CNS) and dementia, end-stage liver disease, coronary artery disease, renal failure 3. Acute infection of any kind previous 6 weeks 4. Pregnancy or a possibility of pregnancy 5. Anemia 6. Inability to undergo PFT, CPET, or MR imaging (usual clinical standard criteria for MRI) 7. Prior cigarette smoking of greater than one pack-year within six months before enrolling in the study. 8. Using a non-closed container, custom-made electronic cigarette juice, or inability for the study team to access "closed-container" and "pre-packaged" electronic cigarette juice for chemical analysis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison between e-cig user vs. healthy participants at baseline and 12 month later | baseline and 12 month follow-up | Hyperpolarized MRI (ventilation defect, RBC/Gas, Membrane/Gas, and RBC/membrane numbers) capillaries using HXeMRI, and corroborate the HXeMRI signatures with the CPET for 40 healthy participants and 40 e-cigarette users use at an initial visit (V1) and a follow-up visit 12-months later (V2). |
| Acute effects of e-cig in e-cig users before and after using one usual dose at baseline and 12 months follow-up | baseline and 12 months follow-up | Cardiopulmonary stress test maximum oxygen uptake |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute Effects of eCig use at baseline and 12 months follow-up | baseline and 12 months follow-up | blood levels of 32 chemical toxins |
Countries
United States
Contacts
CONTACTRoselove Asare, MA
CONTACTCaleigh Smith, BS
PRINCIPAL_INVESTIGATORYun M Shim, MD
University of Virginia
Outcome results
None listed