- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06860698
The Impact of Chronic E-Cigarette Usage on Microvascular Health
April 2, 2026 updated by: Virginia Commonwealth University
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.
Study Overview
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.
Study Type
Observational
Enrollment (Estimated)
44
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Paula Rodriguez Miguelez
- Phone Number: (804) 396-4498
- Email: prodriguezmig@vcu.edu
Study Locations
-
-
Virginia
-
Richmond, Virginia, United States, 23298
- Recruiting
- Virginia Commonwealth University
-
Contact:
- Paula Rodriguez Miguelez
- Phone Number: 804-396-4498
- Email: prodriguezmig@vcu.edu
-
-
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.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Chronic e-cigs users and never users that are between 18 and 29 years of age.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Chronic e-cigs users
Used e-cigarettes with nicotine (≥3 times/week for ≥6 months)
|
Based on e-cigarette usage, participants will be divided into those who used e-cigarettes and those who did not use e-cigarettes
|
|
Never Users
Use of cigarettes or other tobacco products less than 50 times in their lifetime.
|
Based on e-cigarette usage, participants will be divided into those who used e-cigarettes and those who did not use e-cigarettes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Endothelial dependent dilation
Time Frame: Participation is one week
|
Endothelial-dependent dilation will be assessed using laser doppler speckle contrast in both groups through the intervention
|
Participation is one week
|
|
Neurogenic response
Time Frame: Participation is one week
|
Neurogenic response will be assessed using axon reflex in both groups through the intervention
|
Participation is one week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Paula Rodriguez Miguelez, Virginia Commonwealth University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 14, 2023
Primary Completion (Estimated)
April 28, 2026
Study Completion (Estimated)
April 28, 2026
Study Registration Dates
First Submitted
February 24, 2025
First Submitted That Met QC Criteria
February 28, 2025
First Posted (Actual)
March 6, 2025
Study Record Updates
Last Update Posted (Actual)
April 3, 2026
Last Update Submitted That Met QC Criteria
April 2, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HM20029023
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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