Early Detection of Vaping-related Vascular Diseases
ENDS
1 other identifier
observational
90
1 country
1
Brief Summary
The purpose of this study is to determine how vaping affects blood vessels, in particular if early damage occurs in the lung vessels.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2022
CompletedFirst Posted
Study publicly available on registry
July 12, 2022
CompletedStudy Start
First participant enrolled
September 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
May 28, 2025
May 1, 2025
3.8 years
June 30, 2022
May 25, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Airway blood flow reactivity (QAW)
QAW will be measured via soluble gas uptake method
Up to 1 week
Pulmonary vascular resistance (PVR)
PVR will be measured via echocardiography
Up to 4 weeks
Flow-mediated vasodilation (FMD)
FMD will be measured by blood pressure cuff deflation using ultrasound
Up to 4 weeks
Study Arms (3)
Healthy Volunteer Group
Participants who have never smoked or vaped
High Frequency Vaping Group
Participants who vape \>20 days per month.
Low-Frequency Vaping Group
Participants who vape \< 20 days per month
Eligibility Criteria
Healthy non smokers and vapers residing in Florida
You may qualify if:
- Vapers Group:
- Current electronic cigarette (EC) Puff Bar users defined as using EC either daily or occasionally in the past 30 days for at least 6 months, and with 5% nicotine concentration pods.
- Adults aged 18-40 years
- Healthy Group:
- Healthy never smokers, never vapers
- Adults aged 18-40 years
You may not qualify if:
- Current or past smoking of tobacco cigarette (TC) or other tobacco/nicotine products (e.g., smokeless tobacco, Hookah) or marijuana will be excluded from the study.
- Subjects with self-reported history of chronic health problems including asthma, chronic obstructive pulmonary disease (COPD), morbid obesity (BMI\>40 kg/m2), hypertension or diabetes
- Pregnant or breastfeeding women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Miamilead
- Florida Department of Healthcollaborator
Study Sites (1)
University of Miami Health System
Miami, Florida, 33136, United States
Biospecimen
Oral swabs
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adam Wanner, MD
University of Miami
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
June 30, 2022
First Posted
July 12, 2022
Study Start
September 12, 2022
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
May 28, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share