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| ID | Type | Description | Link |
|---|---|---|---|
| Pro00116167 | Other Identifier | Duke University IRB |
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| Name | Class |
|---|---|
| Duke University | OTHER |
| George Mason University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Participants | Other | Young, healthy subjects without any lung disease or other inflammatory diseases. |
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| eCig user | Experimental | Young, otherwise healthy subjects who have used electronic cigarettes for at least 6 months past year. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperpolarized xenon 129 | Drug | Determine the impact of e-cigarette use on pulmonary gas exchange capacity in interstitial tissues and capillaries using hyperpolarized xenon-129 MRI. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison between e-cig user vs. healthy participants at baseline and 12 month later | 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). | baseline and 12 month follow-up |
| Acute effects of e-cig in e-cig users before and after using one usual dose at baseline and 12 months follow-up | Cardiopulmonary stress test maximum oxygen uptake | baseline and 12 months follow-up |
| Acute effects of e-cig in e-cig users before and after using one usual dose at baseline and 12 months follow-up | Pulmonary Function Test with 6 minute walk test | Baseline and 12 months follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Effects of eCig use at baseline and 12 months follow-up | blood levels of 32 chemical toxins | baseline and 12 months follow-up |
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Inclusion Criteria:
Ages between 18 and 35 years old.
At their baseline health
Ability to understand a written informed consent form and comply with the requirements of the study.
Exclusive long-term, recent, and greater than six months continuous e-cigarette use with greater than three days a week frequency.
Users of "closed-container" and "pre-packaged" electronic cigarette juices that must contain nicotine.
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)
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roselove Asare, MA | Contact | 4342436074 | rnn3b@virginia.edu | |
| Caleigh Smith, BS | Contact | 434-243-1140 | RJT3QF@uvahealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Yun M Shim, MD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Recruiting | Durham | North Carolina | 27705 | United States |
As a part of publications.
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| ID | Term |
|---|---|
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D005080 | Exercise Test |
| D012129 | Respiratory Function Tests |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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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.
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| Cardiopulmonary Stress Test | Diagnostic Test | Exercise stress test to evaluate cardiac and pulmonary fitness. |
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| Pulmonary Function Test | Diagnostic Test | Standard clinic pulmonary function test to evaluate lung function |
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| Chest CT | Diagnostic Test | Clinical standard chest computer tomography to evaluate any lung tissue scars or air movement. |
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| University of Virginia | Recruiting | Charlottesville | Virginia | 22908 | United States |
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| D003948 | Diagnostic Techniques, Respiratory System |
| D016552 | Ergometry |
| D008919 | Investigative Techniques |