Dissolved Phase HXe-129 MRI: a Novel Biomarker to Quantify Pulmonary Pathology in Young Healthy E-cigarette Users

Description

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.

Conditions

Electronic Cigarette Related Lung Damage

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Study Overview

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Study Details

Study overview

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.

Dissolved Phase Hyperpolarized Xenon-129 MRI: a Novel Biomarker to Quantify Pulmonary Pathology in Young Healthy E-cigarette Users

Dissolved Phase HXe-129 MRI: a Novel Biomarker to Quantify Pulmonary Pathology in Young Healthy E-cigarette Users

Condition
Electronic Cigarette Related Lung Damage
Intervention / Treatment

-

Contacts and Locations

Durham

Duke University, Durham, North Carolina, United States, 27705

Charlottesville

University of Virginia, Charlottesville, Virginia, United States, 22908

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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. At baseline, normal spirometry with or without bronchodilator, plethysmograph lung volume, carbon monoxide diffusion capacity, and 6-minute walk by ATS/ERS with Global Lung Initiative Reference.
  • 1. History of any other lung disease
  • 2. History of brain diseases including stroke 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
  • 9. Significant history of smoking other substances in the past year.

Ages Eligible for Study

18 Years to 35 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Y. Michael Shim, MD,

Yun M Shim, MD, PRINCIPAL_INVESTIGATOR, University of Virginia

Study Record Dates

2032-12-31