- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02612701
E-Cigarette Aerosol, Conventional Cigarette Smoke, and Myocardial Perfusion
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
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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Subjects will smoke a standard cigarette (yield: tar 12 mg, nicotine 1 mg)
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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.
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Subjects will smoke nicotine free e-liquid with an e-cigarette.
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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.
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Subjects will smoke low nicotine (4-6 mg/mL) e-liquid with an e-cigarette.
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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.
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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
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Myocardial contrast echocardiography will be used to measure regional myocardial perfusion - microvascular flux rate
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Baseline and 30 minutes after smoking
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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
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Coronary Artery Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Ganglionic Stimulants
- Nicotinic Agonists
- Cholinergic Agonists
- Nicotine
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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