Early Detection of Vaping-related Vascular Diseases

Vaping Clinical Trial

— ENDS  

Official title:

Early Detection of Vaping-related Vascular Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05454267
• Other study ID #: 20211060
• Status: Recruiting
• Start date: September 12, 2022
• Est. completion date: July 10, 2024

Study information

• Verified date: August 2023
• Source: University of Miami
• Contact: Adam Wanner, MD
• Phone: (305)243-2568
• Email: awanner[@]med.miami.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine how vaping affects blood vessels, in particular if early damage occurs in the lung vessels.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 10, 2024
• Est. primary completion date: July 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Vaping
• Vascular Diseases
• Vascular System Injuries

Locations

Country	Name	City	State
United States	University of Miami Health System	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Florida Department of Health

Country where clinical trial is conducted

United States, 

Outcome

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