Using MRI to Measure Lung Damage in Young E-cigarette Users

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study involves a longitudinal assessment of 40 young electronic cigarette users and 40 healthy controls to evaluate the impact of e-cigarette use on lung function. Participants will undergo hyperpolarized xenon-129 MRI and cardiopulmonary stress tests at the beginning and after 12 months. The goal is to quantify changes in pulmonary gas exchange capacity and physical fitness related to e-cigarette use. The study aims to provide insights into the early effects of vaping on lung health.

Why it matters

Who can join: the full rules

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)

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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

Where it's running

• Duke University
  Durham, North Carolina, United States Recruiting
• University of Virginia
  Charlottesville, Virginia, United States Recruiting

Study contacts

• Principal investigator: Yun M Shim, MD — University of Virginia
• Study coordinator: Roselove Asare, MA
• Email: rnn3b@virginia.edu
• Phone: 4342436074

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.