Early Detection of Vaping-related Vascular Diseases

Recruiting

• Conditions: Blood Vessel Injury; Vaping

• Registration Number: NCT05454267
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-30
• Study First Submitted QC: 2022-07-07
• Study First Posted: 2022-07-12
• Study Start: 2022-09-12
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-27
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Vapers Group:

1. 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.
2. Adults aged 18-40 years

Healthy Group:

1. Healthy never smokers, never vapers
2. Adults aged 18-40 years

Exclusion Criteria

1. 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.
2. 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
3. Pregnant or breastfeeding women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Airway blood flow reactivity (QAW)	Up to 1 week	QAW will be measured via soluble gas uptake method
Pulmonary vascular resistance (PVR)	Up to 4 weeks	PVR will be measured via echocardiography
Flow-mediated vasodilation (FMD)	Up to 4 weeks	FMD will be measured by blood pressure cuff deflation using ultrasound

Trial Locations

Locations (1)

University of Miami Health System; 🇺🇸 Miami, Florida, United States