Investigation of the Effects of Electronic Cigarettes on Vascular Health

Memorial Sloan Kettering Cancer Center1 site in 1 country12 target enrollmentFebruary 1, 2017

ConditionsVascular Health

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Vascular Health
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 12
Locations: 1
Primary Endpoint: Differences in levels of F2-isoprostanes in participants
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The goal is find out if the use of Electronic cigarettes (EC) leads to the same changes that we see in blood vessels of traditional cigarettes (TC) users. The investigators will also enroll non-smokers as "controls", against which they will measure changes in blood vessels in TC and EC users.

Registry

clinicaltrials.gov

Start Date

February 1, 2017

End Date

June 11, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female between 18 and 50 years of age.
•Good general health with no history of diabetes, coronary artery disease, peripheral arterial disease, chronic disease or hypertension.
•Ability to sign an informed consent.
•Tobacco product users will have additional inclusion criteria:
•For TC smokers, daily TC smoking in the past 6 months, at least 10 cigarettes per day, with no EC exposure in the past 6 months
•For EC users, daily EC use in the past 6 months, at least 10 sessions per day, with no TC exposure in the past 6 month
•For non-smokers, no significant lifetime exposure to any nicotine-containing product, where significant exposure is defined as daily use of any nicotine-containing product for more than one week or once monthly use for more than 6 months.

Exclusion Criteria

•History of renal disease, hypertension, diabetes, congestive heart failure or emphysema
•Use of ACE inhibitors, Angiotensin II receptor blockers, diuretics, aldosterone, renin blockers, aspirin, statins, sildenafil (or other PDE5 inhibitors) and NSAIDs.
•History of substance abuse
•Currently using nicotine replacement or other tobacco cessation products or intentionally abstaining from nicotine-containing products
•IV contrast exposure in the past 1 month
•Inability to place an IV catheter or draw blood for any reason
•Pregnant women or breastfeeding
•Potential subjects will be asked if they are pregnant. Verbal confirmation of pregnancy will be sufficient.
•Fever of \>101°F or BP \>180/95