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Lack of accrual
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| Name | Class |
|---|---|
| Weill Medical College of Cornell University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electronic cigarettes (EC) smokers | Experimental |
| |
| traditional cigarette (TC) smokers | Experimental |
| |
| nonsmokers | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in levels of F2-isoprostanes in participants | F2-isoprostanes in blood and urine | 2 years |
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Inclusion Criteria:
Tobacco product users will have additional inclusion criteria:
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
Fever of >101°F or BP >180/95
BMI ≥30
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| Name | Affiliation | Role |
|---|---|---|
| Roman Shingarev, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Term |
|---|---|
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D066300 | Electronic Nicotine Delivery Systems |
| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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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).
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| 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. |
|
| (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. |
|