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

NCT02612701 | Terminated

• 1 other identifier: Pro00041957
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Myocardial Perfusion

Keywords

Myocardial perfusion; Electronic cigarettes; Cigarettes; Cigarette smoking

Outcome Measures

Primary Outcomes (2)

• 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

  Baseline and 30 minutes after smoking

• 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

  Baseline and 30 minutes after smoking

Study Arms (4)

Cigarettes

EXPERIMENTAL

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

Other: Cigarettes

E-cigarettes (nicotine free e-liquid)

EXPERIMENTAL

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)

E-cigarettes (low nicotine e-liquid)

EXPERIMENTAL

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)

E-cigarettes (high nicotine e-liquid)

EXPERIMENTAL

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)

Interventions

Cigarettes OTHER

Subjects will smoke a standard cigarette (yield: tar 12 mg, nicotine 1 mg)

Cigarettes

E-cigarettes (nicotine free e-liquid) OTHER

Subjects will smoke nicotine free e-liquid with an e-cigarette.

E-cigarettes (nicotine free e-liquid)

E-cigarettes (low nicotine e-liquid) OTHER

Subjects will smoke low nicotine (4-6 mg/mL) e-liquid with an e-cigarette.

E-cigarettes (low nicotine e-liquid)

E-cigarettes (high nicotine e-liquid) OTHER

Subjects will smoke low nicotine (18-24 mg/mL) e-liquid with an e-cigarette.

E-cigarettes (high nicotine e-liquid)

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Vaping; Cigarette Smoking

Interventions

Tobacco Products; Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Smoking; Behavior; Tobacco Smoking; Tobacco Use

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Florian Rader, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D, M.Sc.

Study Record Dates

• First Submitted: November 17, 2015
• First Posted: November 24, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2020
• Last Updated: February 4, 2021

Record last verified: 2021-02

Locations

US (1)