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Recruiting NCT06860698

The Impact of Chronic E-Cigarette Usage on Microvascular Health

— Observational E-Cig Use

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: E-cig use.
Who it may be relevant to
Registry conditions: E-Cig Use. Basic parameters: 18 years — 29 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The study is focused on investigating the mechanisms involved in microvascular health in subjects that use e-cigarettes frequently. To explore microvascular health, different techniques and compounds. For one of the tests, iontophoresis, the drug's use will be stored and handled as described by the approved IND and non-IDS plan.

Detailed description

Electronic cigarettes or e-cigarettes have become increasingly popular, due to their promotion as a healthy alternative to traditional tobacco cigarettes. However, there are large discrepancies of knowledge in understanding how these e-cigarettes affect the subjects health and the way their body uses oxygen. The overall goal of this study is to evaluate e-cigarettes usage on subjects health.

Interventions

  • Other E-cig use
    Based on e-cigarette usage, participants will be divided into those who used e-cigarettes and those who did not use e-cigarettes

Primary outcome measures

  • Endothelial dependent dilation [Time frame: Participation is one week]
  • Neurogenic response [Time frame: Participation is one week]

Eligibility criteria

e-Cig users arm

Inclusion criteria

  • Between 18 and 29 years of age
  • Used e-cigarettes with nicotine (≥3 times/week for ≥6 months)

Exclusion criteria

  • 17 years old and younger or 30 years old or older.
  • Former combustible tobacco user/ former smoker
  • Use of cigarettes for 15 days or more in the past 60 days
  • Use of other tobacco products (cigars, hookah, smokeless), marijuana and/or illicit or prescription drugs weekly or more frequently in the past 60 days
  • Evidence of cardiovascular, pulmonary, renal, hepatic, metabolic, cerebral diseases or sleep disorders
  • Disorder or use of medication that affects cardiopulmonary health
  • Evidence of pregnancy or current nursing

Non e-Cig using arm

Inclusion

\- Between 18 and 29 years of age

Exclusion

  • 17 years old and younger or 30 years old and older
  • Use of cigarettes or other tobacco products more than 50 times in their lifetime.
  • Evidence of cardiovascular, pulmonary, renal, hepatic, metabolic, cerebral diseases or sleep disorders
  • Disorder or use of medication that affects cardiopulmonary health
  • Evidence of pregnancy or current nursing

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Virginia Commonwealth University — Richmond

Identifiers

NCT: NCT06860698 · HM20029023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗