Clinical trial NCT03041493: Investigation of the Effects of Electronic Cigarettes on Vascular Health
Official title: Investigation of the Effects of Electronic Cigarettes on Vascular Health
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vascular Health
Keywords: Electronic Cigarettes
17-071
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Weill Medical College of Cornell University
First posted: 2017-02-02
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, non-randomized case controlled study of the effects of electronic cigarettes on vascular health. The study population will comprise the three groups based on the criteria EC users (experimental group), (TC) smokers (positive control) and nonsmokers (negative control).
Primary purpose: DIAGNOSTIC

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.


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
* BMI ≥30

Primary outcomes:
measure: Differences in levels of F2-isoprostanes in participants
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Roman Shingarev, MD
role: PRINCIPAL_INVESTIGATOR
References: