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Investigation of the Effects of Electronic Cigarettes on Vascular Health

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ClinicalTrials.gov Identifier: NCT03041493
Recruitment Status : Recruiting
First Posted : February 2, 2017
Last Update Posted : March 3, 2020
Sponsor:
Collaborator:
Weill Medical College of Cornell University
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Vascular Health Behavioral: Electronic cigarette Behavioral: traditional cigarette Behavioral: (sham cigarette) - no actual exposure to cigarettes Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 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).
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Investigation of the Effects of Electronic Cigarettes on Vascular Health
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

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.




Primary Outcome Measures :
  1. Differences in levels of F2-isoprostanes in participants [ Time Frame: 2 years ]
    F2-isoprostanes in blood and urine



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041493


Contacts
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Contact: Roman Shingarev, MD 212-639-5513 shingarr@mskcc.org
Contact: Edgar Jaimes, MD 212-639-5109

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Roman Shingarev, MD    212-639-5513      
Contact: Edgar Jaimes    212-639-5109      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Roman Shingarev, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03041493    
Other Study ID Numbers: 17-071
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Electronic Cigarettes
17-071