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

Primary Purpose

Coronary Artery Disease, Myocardial Perfusion

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cigarettes
E-cigarettes (nicotine free e-liquid)
E-cigarettes (low nicotine e-liquid)
E-cigarettes (high nicotine e-liquid)
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Coronary Artery Disease focused on measuring Myocardial perfusion, Electronic cigarettes, Cigarettes, Cigarette smoking

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cedars-Sinai Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Cigarettes

E-cigarettes (nicotine free e-liquid)

E-cigarettes (low nicotine e-liquid)

E-cigarettes (high nicotine e-liquid)

Arm Description

Healthy chronic dual cigarette and e-cigarette smokers will undergo myocardial contrast echocardiography before and after smoking two standard cigarettes

Healthy chronic dual cigarette and e-cigarette smokers will undergo myocardial contrast echocardiography before and after smoking nicotine free e-cigarette 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.

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.

Outcomes

Primary Outcome Measures

Myocardial Perfusion (change in microvascular flux rate from baseline at 30 minutes)
Myocardial contrast echocardiography will be used to measure regional myocardial perfusion - microvascular flux rate
Myocardial Perfusion (change in capillary blood volume from baseline at 30 minutes)
Myocardial contrast echocardiography will be used to measure regional myocardial perfusion - capillary blood volume

Secondary Outcome Measures

Full Information

First Posted
November 17, 2015
Last Updated
February 2, 2021
Sponsor
Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02612701
Brief Title
E-Cigarette Aerosol, Conventional Cigarette Smoke, and Myocardial Perfusion
Official Title
E-Cigarette Aerosol, Conventional Cigarette Smoke, and Myocardial Perfusion
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
Due to the pandemic we decided to terminate this project.
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
October 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Myocardial Perfusion
Keywords
Myocardial perfusion, Electronic cigarettes, Cigarettes, Cigarette smoking

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cigarettes
Arm Type
Experimental
Arm Description
Healthy chronic dual cigarette and e-cigarette smokers will undergo myocardial contrast echocardiography before and after smoking two standard cigarettes
Arm Title
E-cigarettes (nicotine free e-liquid)
Arm Type
Experimental
Arm Description
Healthy chronic dual cigarette and e-cigarette smokers will undergo myocardial contrast echocardiography before and after smoking nicotine free e-cigarette liquid.
Arm Title
E-cigarettes (low nicotine e-liquid)
Arm Type
Experimental
Arm Description
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.
Arm Title
E-cigarettes (high nicotine e-liquid)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cigarettes
Intervention Description
Subjects will smoke a standard cigarette (yield: tar 12 mg, nicotine 1 mg)
Intervention Type
Other
Intervention Name(s)
E-cigarettes (nicotine free e-liquid)
Intervention Description
Subjects will smoke nicotine free e-liquid with an e-cigarette.
Intervention Type
Other
Intervention Name(s)
E-cigarettes (low nicotine e-liquid)
Intervention Description
Subjects will smoke low nicotine (4-6 mg/mL) e-liquid with an e-cigarette.
Intervention Type
Other
Intervention Name(s)
E-cigarettes (high nicotine e-liquid)
Intervention Description
Subjects will smoke low nicotine (18-24 mg/mL) e-liquid with an e-cigarette.
Primary Outcome Measure Information:
Title
Myocardial Perfusion (change in microvascular flux rate from baseline at 30 minutes)
Description
Myocardial contrast echocardiography will be used to measure regional myocardial perfusion - microvascular flux rate
Time Frame
Baseline and 30 minutes after smoking
Title
Myocardial Perfusion (change in capillary blood volume from baseline at 30 minutes)
Description
Myocardial contrast echocardiography will be used to measure regional myocardial perfusion - capillary blood volume
Time Frame
Baseline and 30 minutes after smoking

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florian Rader, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States

12. IPD Sharing Statement

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

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