Hyperpolarized Xenon 129
DrugDetermine the impact of e-cigarette use on pulmonary gas exchange capacity in interstitial tissues and capillaries using hyperpolarized xenon-129 MRI.
Other names: 129HxeMRI
NCT Number: NCT06856525
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.
Interested in participating?
Request Info18 year–35 year
All sexes
Interventional
Phase 2 / Phase 3
Duke University, Durham, North Carolina, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-
Exclusion criteria
Determine the impact of e-cigarette use on pulmonary gas exchange capacity in interstitial tissues and capillaries using hyperpolarized xenon-129 MRI.
Other names: 129HxeMRI
Exercise stress test to evaluate cardiac and pulmonary fitness.
Other names: CPET
Standard clinic pulmonary function test to evaluate lung function
Other names: PFT
Clinical standard chest computer tomography to evaluate any lung tissue scars or air movement.
Time frame: 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).
Time frame: baseline and 12 months follow-up
Cardiopulmonary stress test maximum oxygen uptake
Time frame: Baseline and 12 months follow up
Pulmonary Function Test with 6 minute walk test
Time frame: baseline and 12 months follow-up
blood levels of 32 chemical toxins
Contact information is provided by the study sponsor or research team.
Caleigh Smith, BS
CONTACT
Roselove Asare, MA
CONTACT
Y. Michael Shim, MD
Other
Dissolved Phase Hyperpolarized Xenon-129 MRI: a Novel Biomarker to Quantify Pulmonary Pathology in Healthy Participants and E-cigarette Users
Acronym: ECig
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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