NCT02612701

E-Cigarette Aerosol, Conventional Cigarette Smoke, and Myocardial Perfusion

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

E-cigarettes deliver nicotine by creating an aerosol of ultrafine particles. Many questions remain about the size and composition and especially about the potential toxicity of these particles. Thus, a key unanswered question-and the research question proposed-is whether e-cigarette aerosol triggers the same acute impairment in coronary microvessel function as does conventional cigarette smoke, which delivers a very well-defined exposure to fine particles and many fold greater exposure to toxic (combustion) products including volatile organic compounds (such as acrolein) that have been implicated in the pathogenesis of tobacco-related coronary disease. Because the effects of nicotine on the human coronary microcirculation remain incompletely defined-with multiple potential vasodilator and vasoconstrictor actions each of which may vary by dose-we will determine the comparative effects of conventional cigarette smoke against e-cigarette aerosol with no nicotine, with low-dose nicotine, and with high-dose nicotine.

Conditions

• Coronary Artery Disease
• Myocardial Perfusion

Interventions

Type	Name	Description
OTHER	Cigarettes	Subjects will smoke a standard cigarette (yield: tar 12 mg, nicotine 1 mg)
OTHER	E-cigarettes (nicotine free e-liquid)	Subjects will smoke nicotine free e-liquid with an e-cigarette.
OTHER	E-cigarettes (low nicotine e-liquid)	Subjects will smoke low nicotine (4-6 mg/mL) e-liquid with an e-cigarette.
OTHER	E-cigarettes (high nicotine e-liquid)	Subjects will smoke low nicotine (18-24 mg/mL) e-liquid with an e-cigarette.

Timeline

• Start date: 2015-10-01
• Primary completion: 2018-10-01
• Completion: 2020-10-01
• First posted: 2015-11-24
• Last updated: 2021-02-04

Locations

1 site across 1 country: United States