Recruiting NCT05454267
Early Detection of Vaping-related Vascular Diseases
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
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Vaping, Blood Vessel Injury. Basic parameters: 18 years — 40 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 purpose of this study is to determine how vaping affects blood vessels, in particular if early damage occurs in the lung vessels.
Primary outcome measures
- Airway blood flow reactivity (QAW) [Time frame: Up to 1 week]
- Pulmonary vascular resistance (PVR) [Time frame: Up to 4 weeks]
- Flow-mediated vasodilation (FMD) [Time frame: Up to 4 weeks]
Eligibility criteria
Inclusion criteria
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
Exclusion criteria
- 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
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
- Other
Study locations
United States · 1 center
- University of Miami Health System — Miami
Identifiers
NCT: NCT05454267 · 20211060