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

NCT02612701 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-02-04

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Cedars-Sinai Medical Center

    lead OTHER

Principal Investigators

  • Florian Rader, MD · Cedars-Sinai Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2018-10-01
Completion
2020-10-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02612701 on ClinicalTrials.gov