RecruitingNCT04616313

Novel Pulmonary Imaging of Lung Structure and Function in E-cigarette Smokers

Novel Pulmonary Imaging of Lung Structure and Function in Symptomatic and Asymptomatic E-cigarette Smokers


Sponsor

Western University, Canada

Enrollment

150 participants

Start Date

Jan 17, 2023

Study Type

OBSERVATIONAL

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

Min Age: 16 Years

Inclusion Criteria6

  • 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.
  • participants will be c-cigarette never users.
  • participants will be former or current c-cigarette users.
  • asymptomatic age and sex-matched healthy people who have never used e- or c-cigarettes will be controls.

Exclusion Criteria3

  • 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIAGNOSTIC_TESTHyperpolarized Xenon-129 MRI of the lungs

Participants will be imaged using MRI using hyperpolarized xenon-129 gas as a contrast gas

DIAGNOSTIC_TESTComputed Tomography (CT)

Participants will undergo a CT scan of the thoracic cavity

DIAGNOSTIC_TESTPulmonary Function Tests (PFT)

Participants will have their lung function evaluated using PFT

DIAGNOSTIC_TESTCardiopulmonary exercise testing (CPET)

Participants will perform cardiopulmonary exercise testing as a measure of exercise capacity

DIAGNOSTIC_TESTSputum analysis

Participants will provide a sputum sample that will be analysed for eosinophils

DIAGNOSTIC_TESTBlood analysis

Participants will have their blood drawn and analysed for eosinophil count.

OTHERQuestionnaires

Participants will complete questionnaires to assess activity related dyspnea, respiratory symptoms and health status impairment and respiratory related quality of life.


Locations(1)

Robarts Research Institute; The University of Western Ontario; London Health Sciences Centre

London, Ontario, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04616313