NCT05454267

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Sep 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Sep 2022Dec 2026

First Submitted

Initial submission to the registry

June 30, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 12, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

September 12, 2022

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

3.8 years

First QC Date

June 30, 2022

Last Update Submit

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

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

Study Sites (1)

University of Miami Health System

Miami, Florida, 33136, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Oral swabs

MeSH Terms

Conditions

VapingVascular System Injuries

Condition Hierarchy (Ancestors)

SmokingBehaviorVascular DiseasesCardiovascular DiseasesWounds and Injuries

Study Officials

  • Adam Wanner, MD

    University of Miami

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Campos, MD

CONTACT

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

Locations