Investigation of the Effects of Electronic Cigarettes on Vascular Health

NCT03041493 | Terminated

• 1 other identifier: 17-071
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Health

Keywords

Electronic Cigarettes; 17-071

Outcome Measures

Primary Outcomes (1)

• Differences in levels of F2-isoprostanes in participants

  F2-isoprostanes in blood and urine

  2 years

Study Arms (3)

Electronic cigarettes (EC) smokers

EXPERIMENTAL

Behavioral: Electronic cigarette

traditional cigarette (TC) smokers

EXPERIMENTAL

Behavioral: traditional cigarette

nonsmokers

ACTIVE COMPARATOR

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

Interventions

Electronic cigarette BEHAVIORAL

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.

Electronic cigarettes (EC) smokers

traditional cigarette BEHAVIORAL

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.

traditional cigarette (TC) smokers

(sham cigarette) - no actual exposure to cigarettes BEHAVIORAL

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.

nonsmokers

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Weill Medical College of Cornell University: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Vaping

Interventions

Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Smoking; Behavior

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Roman Shingarev, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: February 2, 2017
• Study Start: February 1, 2017
• Primary Completion: June 11, 2021
• Study Completion: June 11, 2021
• Last Updated: June 18, 2021

Record last verified: 2021-06

Locations

US (1)