Investigation of the Effects of Electronic Cigarettes on Vascular Health

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Terminated

CT.gov ID

NCT03041493

Collaborator

Weill Medical College of Cornell University (Other)

Enrollment

Location

Arms

52.3

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vascular Health	Behavioral: Electronic cigarette Behavioral: traditional cigarette Behavioral: (sham cigarette) - no actual exposure to cigarettes	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

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).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).

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Investigation of the Effects of Electronic Cigarettes on Vascular Health

Actual Study Start Date :

Feb 1, 2017

Actual Primary Completion Date :

Jun 11, 2021

Actual Study Completion Date :

Jun 11, 2021

Arms and Interventions

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.

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

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.

Outcome Measures

Primary Outcome Measures

Differences in levels of F2-isoprostanes in participants [2 years]
F2-isoprostanes in blood and urine

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065

Sponsors and Collaborators

Memorial Sloan Kettering Cancer Center
Weill Medical College of Cornell University

Investigators

Principal Investigator: Roman Shingarev, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Memorial Sloan Kettering Cancer Center

Publications

None provided.

Responsible Party:

Memorial Sloan Kettering Cancer Center

ClinicalTrials.gov Identifier:

NCT03041493

Other Study ID Numbers:

17-071

First Posted:

Feb 2, 2017

Last Update Posted:

Jun 18, 2021

Last Verified:

Jun 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Memorial Sloan Kettering Cancer Center

Electronic Cigarettes

17-071

Study Results

No Results Posted as of Jun 18, 2021