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

February 2, 2021 updated by: Florian Rader, Cedars-Sinai Medical Center

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-49
  • Regular cigarette smoker defined as at least 1 pack year and ≥ 5/day
  • E-cigarette smoker defined as ≥ 1/week in the last 6 months.

Exclusion Criteria:

  • Sub-optimal echocardiography images as determined by the sonographer and/or investigators.
  • History of cardiopulmonary (including asthma or use of inhalers),
  • History of diabetes or dyslipidemia
  • History of psychiatric illness
  • Blood Pressure > 140/90
  • Body Mass Index ≤ 18.5 or ≥ 30 kg•m2
  • Evidence of any of the above by physical examination, Electrocardiogram (ECG) or echocardiogram
  • Resting Heart Rate > 100 beats/min
  • Cardiac rhythm disorder, specifically: rhythm other than sinus, Supraventricular Tachycardia (SVT), atrial fibrillation, ventricular tachycardia
  • Use of prescription medication except oral contraceptive pills
  • History of illicit drug use (self-stated)
  • Pregnant
  • Any other condition(s) deemed by the physician investigators that put subjects at risk for participating in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cigarettes
Healthy chronic dual cigarette and e-cigarette smokers will undergo myocardial contrast echocardiography before and after smoking two standard cigarettes
Other: Cigarettes
Subjects will smoke a standard cigarette (yield: tar 12 mg, nicotine 1 mg)
Experimental: E-cigarettes (nicotine free e-liquid)
Healthy chronic dual cigarette and e-cigarette smokers will undergo myocardial contrast echocardiography before and after smoking nicotine free e-cigarette liquid.
Other: E-cigarettes (nicotine free e-liquid)
Subjects will smoke nicotine free e-liquid with an e-cigarette.
Experimental: E-cigarettes (low nicotine e-liquid)
Healthy chronic dual cigarette and e-cigarette smokers will undergo myocardial contrast echocardiography before and after smoking low concentration(4-6 mg/mL) e-cigarette liquid.
Other: E-cigarettes (low nicotine e-liquid)
Subjects will smoke low nicotine (4-6 mg/mL) e-liquid with an e-cigarette.
Experimental: E-cigarettes (high nicotine e-liquid)
Healthy chronic dual cigarette and e-cigarette smokers will undergo myocardial contrast echocardiography before and after smoking high concentration (18-24 mg/mL) e-cigarette liquid.
Other: E-cigarettes (high nicotine e-liquid)
Subjects will smoke low nicotine (18-24 mg/mL) e-liquid with an e-cigarette.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myocardial Perfusion (change in microvascular flux rate from baseline at 30 minutes)
Time Frame: Baseline and 30 minutes after smoking
Myocardial contrast echocardiography will be used to measure regional myocardial perfusion - microvascular flux rate
Baseline and 30 minutes after smoking
Myocardial Perfusion (change in capillary blood volume from baseline at 30 minutes)
Time Frame: Baseline and 30 minutes after smoking
Myocardial contrast echocardiography will be used to measure regional myocardial perfusion - capillary blood volume
Baseline and 30 minutes after smoking

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

October 1, 2020

Study Registration Dates

First Submitted

November 17, 2015

First Submitted That Met QC Criteria

November 20, 2015

First Posted (Estimate)

November 24, 2015

Study Record Updates

Last Update Posted (Actual)

February 4, 2021

Last Update Submitted That Met QC Criteria

February 2, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00041957

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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