Early Detection of Vaping-related Vascular Diseases (ENDS)

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

Study Overview

• Status: Recruiting
• Conditions: Vaping; Blood Vessel Injury

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: Adam Wanner, MD; Phone Number: (305)243-2568; Email: awanner@med.miami.edu
• Study Contact Backup: Name: Michael Campos, MD; Phone Number: 3052436388; Email: mcampos1@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami Health System
      • Principal Investigator: Adam Wanner, MD
      • Contact: Michael Campos, MD; Phone Number: 305-243-6388; Email: mcampos1@med.miami.edu
      • Sub-Investigator: Michael Campos, MD
      • Sub-Investigator: Barry Hurwitz, MD
      • Sub-Investigator: Taghrid Asfar, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy non smokers and vapers residing in Florida

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Florida Department of Health
• Investigators: Principal Investigator: Adam Wanner, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2022
• Primary Completion (Estimated): July 10, 2024
• Study Completion (Estimated): July 10, 2024

Study Registration Dates

• First Submitted: June 30, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 12, 2022

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Wounds and Injuries; Vascular Diseases; Vascular System Injuries
• Other Study ID Numbers: 20211060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No