Dissolved Phase HXe-129 MRI: A Novel Biomarker to Quantify Pulmonary Pathology (NCT06856525) | Clinical Trial Compass
RecruitingPhase 2/3
Dissolved Phase HXe-129 MRI: A Novel Biomarker to Quantify Pulmonary Pathology
United States80 participantsStarted 2024-12-19
Plain-language 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.
Who can participate
Age range18 Years – 35 Years
SexALL
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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)
Exclusion criteria
✕. History of any other lung disease
✕. History of brain diseases including stroke (CNS) and dementia, end-stage liver disease, coronary artery disease, renal failure
✕. Acute infection of any kind previous 6 weeks
✕. Pregnancy or a possibility of pregnancy
✕. Anemia
✕. Inability to undergo PFT, CPET, or MR imaging (usual clinical standard criteria for MRI)
What they're measuring
1
Comparison between e-cig user vs. healthy participants at baseline and 12 month later
Timeframe: baseline and 12 month follow-up
2
Acute effects of e-cig in e-cig users before and after using one usual dose at baseline and 12 months follow-up
Timeframe: baseline and 12 months follow-up
3
Acute effects of e-cig in e-cig users before and after using one usual dose at baseline and 12 months follow-up
. Prior cigarette smoking of greater than one pack-year within six months before enrolling in the study.
✕. 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