A Study to Evaluate Imaging in Non-urgent, Symptomatic and Asymptomatic Individuals with E-cigarette or Vaping Lung Injury

Overview

About this study

The purpose of this study is to evaluate the hypothesis that e-cigarette use, or vaping, product-associated lung injury (EVALI) is underdiagnosed and can be detected on high resolution computed tomography (HRCT) in non-urgent, symptomatic and asymptomatic phases.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • ≥ 18 and ≤ 45 years of age.
  • Asymptomatic individuals who vape at least once a week for the past 6 months or longer OR individuals with non-urgent symptoms possibly related to vaping whose symptom onset occurred during at least weekly vaping use for 3 months or longer (non-urgent is defined as in the opinion of the investigator or primary care physician, the patient does not require urgent/emergent medical care for symptom management).
  • Current vapers or those vapers who have quit within the past 30 days.
  • If subject is referred by a physician as a symptomatic patient, his or her health history, medications, review of symptoms, and physical exam are available in Epic EMR and would have been updated within the past 30 days.
  • Subject is a never smoker - defined as having used less than 100 cigarettes in their lifetime.
  • Able to fully participate in all aspects of the study.
  • Able to understand and sign the consent.
  • Negative pregnancy test if female (available through our study coordinator).
  • Mayo Clinic patient with a primary care physician who can be contacted if medical attention to CT findings is needed.

Exclusion Criteria:

  • Smoked a cigarette/s within the past 30 days.
  • With the exception of asthma, has a known medical condition that causes or can cause lung findings including but not limited to heart disease, liver or kidney failure, amyloidosis, cancer (excluding non-melanoma skin cancer), HIV, immunosuppression, bleeding disorders, cystic fibrosis, emphysema, or any interstitial lung disease.
  • An upper respiratory infection (includes nasal congestion with cough), pneumonia or influenza within the past 30 days.
  • Chronic respiratory symptoms prior to the start of vaping.
  • With the exception of vaping marijuana and THC products, participants must have not use illicit drugs including IV drugs and smoked marijuana.
  • Has an unstable or urgent medical condition as determined by the physician investigator.
  • Expired air carbon monoxide > 8 ppm.
  • Patient needs to be less than 50 cm across at top of liver as measured by the CIC staff.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Rebecca Lindell, M.D.

Open for enrollment

Contact information:

Fatima Zohra

(507) 422-5069

Zohra.Fatima@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20503865

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