Investigation of the Effects of Electronic Cigarettes on Vascular Health

Memorial Sloan Kettering Cancer Center (MSK)

Status: Terminated

Conditions: Vascular Health

Treatments: Behavioral: (sham cigarette) - no actual exposure to cigarettes; Behavioral: Electronic cigarette; Behavioral: traditional cigarette

Study type: Interventional

Funder types: Other

Identifiers

NCT03041493

17-071

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

12 participants in 3 patient groups

Electronic cigarettes (EC) smokers

Experimental group

Treatment:

Behavioral: Electronic cigarette

traditional cigarette (TC) smokers

Experimental group

Treatment:

Behavioral: traditional cigarette

nonsmokers

Active Comparator group

Treatment:

Behavioral: (sham cigarette) - no actual exposure to cigarettes