Investigation of the Effects of Electronic Cigarettes on Vascular Health

Not Applicable

Terminated

• Conditions: Vascular Health
• Interventions: Behavioral: Electronic cigarette; Behavioral: (sham cigarette) - no actual exposure to cigarettes; Behavioral: traditional cigarette

• Registration Number: NCT03041493
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2017-02-01
• Study First Submitted QC: 2017-02-01
• Study First Posted: 2017-02-02
• Status Verified: 2021-06
• Primary Completion: 2021-06-11
• Study Completion: 2021-06-11
• Last Update Submitted: 2021-06-14
• Last Update Posted: 2021-06-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electronic cigarettes (EC) smokers	Electronic cigarette	-
nonsmokers	(sham cigarette) - no actual exposure to cigarettes	-
traditional cigarette (TC) smokers	traditional cigarette	-

Primary Outcome Measures

Name	Time	Method
Differences in levels of F2-isoprostanes in participants	2 years	F2-isoprostanes in blood and urine

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States