Investigation of the Effects of Electronic Cigarettes on Vascular Health

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.

Study Overview

• Status: Terminated
• Conditions: Vascular Health
• Intervention / Treatment: Behavioral: Electronic cigarette; Behavioral: traditional cigarette; Behavioral: (sham cigarette) - no actual exposure to cigarettes

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electronic cigarettes (EC) smokers	Behavioral: Electronic cigarette; During the first encounter, blood pressure and endothelium-dependent relaxation (EDR) will be measured by flow mediated dilatation (FMD), and a small peripheral IV catheter will be placed in the participant's median antecubital or cephalic vein. A blood sample (10 mL) for EPCs and F2-isoprostanes will be collected. One urine sample will also be collected for measurement of urinary F2-isoprostanes, cotinine and creatinine. These will serve as both baseline measures for subsequent acute exposure to nicotine and as measures of chronic nicotine exposure. The second encounter will be scheduled 4 hours after the first encounter. At that time a blood sample (5 mL) for EPCs will be collected followed by harvesting of vascular endothelial cells for eNOS and NF-κB expression.
Experimental: traditional cigarette (TC) smokers	Behavioral: traditional cigarette; During the first encounter, blood pressure and endothelium-dependent relaxation (EDR) will be measured by flow mediated dilatation (FMD), and a small peripheral IV catheter will be placed in the participant's median antecubital or cephalic vein. A blood sample (10 mL) for EPCs and F2-isoprostanes will be collected. One urine sample will also be collected for measurement of urinary F2-isoprostanes, cotinine and creatinine. These will serve as both baseline measures for subsequent acute exposure to nicotine and as measures of chronic nicotine exposure. The second encounter will be scheduled 4 hours after the first encounter. At that time a blood sample (5 mL) for EPCs will be collected followed by harvesting of vascular endothelial cells for eNOS and NF-κB expression.
Active Comparator: nonsmokers	Behavioral: (sham cigarette) - no actual exposure to cigarettes; During the first encounter, blood pressure and endothelium-dependent relaxation (EDR) will be measured by flow mediated dilatation (FMD), and a small peripheral IV catheter will be placed in the participant's median antecubital or cephalic vein. A blood sample (10 mL) for EPCs and F2-isoprostanes will be collected. One urine sample will also be collected for measurement of urinary F2-isoprostanes, cotinine and creatinine. These will be compared to the second set of laboratory measurements done at the second encounter that will be scheduled 4 hours after the first encounter. At that time an additional blood sample (5 mL) for EPCs will be collected followed by harvesting of vascular endothelial cells for eNOS and NF-κB expression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in levels of F2-isoprostanes in participants	F2-isoprostanes in blood and urine	2 years

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Roman Shingarev, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): June 11, 2021
• Study Completion (Actual): June 11, 2021

Study Registration Dates

• First Submitted: February 1, 2017
• First Submitted That Met QC Criteria: February 1, 2017
• First Posted (Estimate): February 2, 2017

Study Record Updates

• Last Update Posted (Actual): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 14, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Electronic Cigarettes; 17-071
• Other Study ID Numbers: 17-071

Drug and device information, study documents

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