Investigation of the Effects of Electronic Cigarettes on Vascular Health

Vascular Health Clinical Trial

Official title:

Investigation of the Effects of Electronic Cigarettes on Vascular Health

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03041493
• Other study ID #: 17-071
• Status: Terminated
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: June 11, 2021

Study information

• Verified date: June 2021
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: June 11, 2021
• Est. primary completion date: June 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Vascular Health

Intervention

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-?B expression.
• 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-?B expression.
• (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-?B expression.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in levels of F2-isoprostanes in participants	F2-isoprostanes in blood and urine	2 years

External Links

•   Memorial Sloan Kettering Cancer Center