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Understanding the Impact of Cartridge-Based Electronic Cigarettes and Generated Aerosols on Cardiopulmonary Health

Understanding the Impact of Cartridge-Based Electronic Cigarettes and Generated Aerosols on Cardiopulmonary Health

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05199480
Enrollment
4
Registered
2022-01-20
Start date
2022-01-10
Completion date
2024-07-30
Last updated
2025-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E-Cig Use

Brief summary

Over the last decade, 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 user's health. The overall goal of this study is to evaluate the impact of e-cigarettes usage on user's cardiopulmonary health

Interventions

DRUGTobacco flavored liquid type 1

A commercially available cartridge-based device with tobacco flavored liquid.

DRUGTobacco flavored liquid type 2

A commercially available cartridge-based device with tobacco flavored liquid.

Sponsors

Virginia Commonwealth University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

E-Cigarette group: * 21 years of age or older * Used e-cigarettes (≥3 times/week for ≥3 months) Non e-cigarette group ● 21 years of age or older

Exclusion criteria

* 20 years old and younger * Use of cigarettes for 15 days or more in the past 60 days * Use of other tobacco products (cigars, hookah, smokeless) weekly or more frequently in the past 60 days * Use of marijuana or any illicit or prescription drugs for non-medical use weekly or more frequently in the past 60 days * Known allergy to propylene glycol or vegetable glycerin * Evidence of cardiovascular, pulmonary, renal, hepatic, metabolic, or cerebral diseases * Disorder or use of medication that affects cardiopulmonary health * Evidence of pregnancy or current nursing

Design outcomes

Primary

MeasureTime frameDescription
Change in Peak oxygen consumption (VO2 peak)Change from baseline to 2 weeksParticipants' peak oxygen consumption (VO2 peak) will be measured using a standardized exercise capacity test performed on a stationary bike.
Change in Expiratory VolumeChange from baseline to 2 weeksParticipants expiratory volume will be measured through spirometry using a pulmonary function device.

Secondary

MeasureTime frameDescription
Change in Skeletal muscle O2 utilizationChange from baseline to 2 weeksAssessment of skeletal muscle oxygen utilization using near-infrared spectroscopy through the ratio of O2 delivery and O2 extraction
Change in Maximal microvascular dilationChange from baseline to 2 weeksParticipants' microvascular function (maximal dilation) will be measured using local thermal hyperemia.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026