Acute Effects of E-Cigarette Aerosol Inhalation

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03479203
• Collaborator: National Institutes of Health (NIH) (NIH), National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 51.3
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The purpose of this study is to examine the acute effects of nicotine free electronic cigarette aerosol on vascular function in healthy, non-smokers.

This study comprises a portion of a larger study comparing results of vascular function in nonsmokers to vascular function in healthy smokers chronically exposed to nicotinized electronic cigarette aerosol versus conventional cigarettes.

Condition or Disease	Intervention/Treatment	Phase
Endothelial Dysfunction; Biochemical Markers	Drug: Electronic Cigarette Aerosol	Early Phase 1

Detailed Description

The purpose of this study is 1) to examine the acute effects of nicotine free e-cigarette aerosol on vascular function in healthy, non-smokers and 2) to examine and compare vascular function in healthy smokers chronically exposed, at baseline and after 12 months, to nicotinized e-cigarette aerosol versus conventional cigarettes as compared to age, gender and body mass index-matched nonsmokers. Vascular function (microvascular reactivity via dynamic femoral oximetry, arterial hyperemia, femoral artery flow-mediated dilation, central pulse-wave velocity, neurovascular reactivity) will be assessed as part of a single integrated MRI protocol. The outcome of the project will provide new insight into the acute and chronic effects of e-cigarette aerosol inhalation in terms of surrogate markers of endothelial dysfunction (EDF), the prime promoter of atherosclerotic cardiovascular disease, and aid toward establishment of future public health advisories.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Acute and Long-term Effects of E-Cigarette Aerosol Inhalation on Biomarkers of Endothelial Function and Vascular Reactivity
• Actual Study Start Date: May 22, 2018
• Anticipated Primary Completion Date: Aug 31, 2022
• Anticipated Study Completion Date: Aug 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Healthy, Non-Smokers Non-nicotinized electronic cigarette aerosol (16 2-second long puffs)	Drug: Electronic Cigarette Aerosol; 16 two-second-long puffs from a non-nicotinized electronic cigarette.

Outcome Measures

Primary Outcome Measures

1. Changes in serum protein levels (micrograms) of inflammatory biomarkers (HMGB-1, RAGE, ICAM, CRP) in non-smoking healthy subjects before and after electronic cigarette aerosol inhalation. [Baseline to six hours]

   High mobility group box-1 (HMGB1), receptor for advanced glycation end products (RAGE), intercellular adhesion molecule (ICAM1) and C-reactive protein (CRP) will be monitored in serum from subjects by ELISA assays measuring the exact concentration of moieties based on absorbance values emanating from the serum samples. Using standard curves, the amount of these biomarkers will be monitored in the range of nmole or pmole/microgram of serum protein. Measurements will be carried out in triplicate for each sample. Data will be quantified as amount of biomarker/microgram serum protein.

2. Aortic pulse-wave velocity (meters/second) [Baseline to six Hours]

   Stiffness of aorta

3. Femoral artery flow-mediated dilation (% fractional change in cross-sectional area) [Baseline to six Hours]

   Degree of dilation of femoral artery during hyperemia (the transient increase in blood flow velocity)

4. Washout time (seconds) [Baseline to six Hours]

   Transit time of desaturated capillary blood from tissue to the imaging location

5. Upslope (%HbO2/seconds) [Baseline to six Hours]

   Tissue oxygen resaturation rate

6. Overshoot (%HbO2) [Baseline to six Hours]

   Degree of overcompensatory effect in supply of oxygen after ischemia

7. Breath hold index (meters/seconds^2) [Baseline to six Hours]

   Rate of increase in blood flow velocity in the superior sagittal sinus from intermittent volitional apnea

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• BMI of 18.5 - 30

Exclusion Criteria:

• Cancer

• HIV

• Mental illness

• Overt cardio- or neurovascular disease (prior heart attack, stroke, transient ischemic attacks)

• Serious arrhythmias

• Bronchospastic disease

• Upper respiratory tract infection within the past six weeks

• Chronic medication or antibiotics

• Claustrophobia / contraindications for MRI

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania Perelman School of Medicine	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania
• National Institutes of Health (NIH)
• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Felix W. Wehrli, Ph.D., University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Felix W. Wehrli, Professor of Radiologic Science, Biochemistry and Biophysics, University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT03479203
• Other Study ID Numbers: 828195; R01HL139358
• First Posted: Mar 27, 2018
• Last Update Posted: Nov 30, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Felix W. Wehrli, Professor of Radiologic Science, Biochemistry and Biophysics, University of Pennsylvania: Inflammation
• Additional relevant MeSH terms: Respiratory Aspiration

Study Results

No Results Posted as of Nov 30, 2021