Hyperpolarized Xenon-129 MRI of the lungsComputed Tomography (CT)Pulmonary Function Tests (PFT)Cardiopulmonary exercise testing (CPET)Sputum analysisBlood analysisQuestionnaires
Hyperpolarized Xenon-129 MRI of the lungs: Participants will be imaged using MRI using hyperpolarized xenon-129 gas as a contrast gas
Computed Tomography (CT): Participants will undergo a CT scan of the thoracic cavity
Pulmonary Function Tests (PFT): Participants will have their lung function evaluated using PFT
Cardiopulmonary exercise testing (CPET): Participants will perform cardiopulmonary exercise testing as a measure of exercise capacity
Sputum analysis: Participants will provide a sputum sample that will be analysed for eosinophils
Blood analysis: Participants will have their blood drawn and analysed for eosinophil count.
Questionnaires: Participants will complete questionnaires to assess activity related dyspnea, respiratory symptoms and health status impairment and respiratory related quality of life.
Study summary
This is a longitudinal study of the long-term health impact of e-cigarette smoking on the lungs. Participants will be followed over a period of 5 years, and impacts of e-cigarette smoking on the lungs will be measured with magnetic resonance imaging (MRI) using hyperpolarized xenon-129 gas, pulmonary function tests, exercise capacity, computed tomography images and questionnaires.
Eligibility
Sex
ALL
Min age
16 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
* Written informed consent must be directly obtained from legally competent participants before any study-related assessment is performed.
* Male and female participant age ≥16 years.
* Participant has recently started vaping, \>1 and \<5 years weekly use.
* 70 participants will be c-cigarette never users.
* 70 participants will be former or current c-cigarette users.
* 10 asymptomatic age and sex-matched healthy people who have never used e- or c-cigarettes will be controls.
Exclusion Criteria:
* Participants with contraindications for undergoing an MRI such as participants with MRI-sensitive implants, tattoos with MRI-sensitive dye and severe claustrophobia.
* Participant is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained, or cannot read or understand written material.
* Participant unable to perform spirometry or plethysmography maneuvers.
Primary outcome measure(s)
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report pulmonary imaging abnormalities. — 12 weeks following enrollment Measured using 129-Xe MRI
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report pulmonary imaging abnormalities. — 12 weeks following enrollment Measured using computed tomography imaging
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by FEV1. — 12 weeks following enrollment Measured using forced expiratory volume in one second (FEV1)
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by FVC. — 12 weeks following enrollment Measured using forced vital capacity (FVC)
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by TLC. — 12 weeks following enrollment Measured using total lung capacity (TLC)
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by FRC. — 12 weeks following enrollment Measured using functional residual capacity (FRC)
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by RV. — 12 weeks following enrollment Measured using residual volume (RV)
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by FOT. — 12 weeks following enrollment Measured using forced oscillation technique (FOT)
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by LCI. — 12 weeks following enrollment Measured using lung clearance index (LCI)
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by FeNO. — 12 weeks following enrollment Measured using Fractional Exhaled Nitric Oxide (FeNO).
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by exercise capacity — 12 weeks following enrollment Exercise capacity measured by cardio-pulmonary exercise testing (CPET)
Trial sites (1)
Facility
City
Region
Status
Robarts Research Institute; The University of Western Ontario; London Health Sciences Centre
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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