Coronary Artery DiseaseNCT02612701
E-Cigarette Aerosol, Conventional Cigarette Smoke, and Myocardial Perfusion
A study testing Cigarettes, E-cigarettes (nicotine free e-liquid) and E-cigarettes (low nicotine e-liquid) in people with Coronary Artery Disease and Myocardial Perfusion, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease, Myocardial Perfusion
- What is being tested?
- Cigarettes, E-cigarettes (nicotine free e-liquid) and E-cigarettes (low nicotine e-liquid)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
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
- Being tested
- Cigarettes, E-cigarettes (nicotine free e-liquid), E-cigarettes (low nicotine e-liquid), E-cigarettes (high nicotine e-liquid)
- Keywords
- Myocardial perfusion, Electronic cigarettes, Cigarettes, Cigarette smoking
- Medical subject headings
- Coronary Artery Disease, Vaping, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CigarettesOther
Subjects will smoke a standard cigarette (yield: tar 12 mg, nicotine 1 mg)
E-cigarettes (nicotine free e-liquid)Other
Subjects will smoke nicotine free e-liquid with an e-cigarette.
E-cigarettes (low nicotine e-liquid)Other
Subjects will smoke low nicotine (4-6 mg/mL) e-liquid with an e-cigarette.
E-cigarettes (high nicotine e-liquid)Other
Subjects will smoke low nicotine (18-24 mg/mL) e-liquid with an e-cigarette.
| Study group | Role | What they receive |
|---|---|---|
| Cigarettes | Experimental | Healthy chronic dual cigarette and e-cigarette smokers will undergo myocardial contrast echocardiography before and after smoking two standard cigarettes Receives: 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. Receives: 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. Receives: 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. Receives: Other: E-cigarettes (high nicotine e-liquid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline and 30 minutes after smoking
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study startOct 2015
- Primary completion1 Oct 2018
- Study completionOct 2020
Why it stopped: Due to the pandemic we decided to terminate this project.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Florian Rader, Cedars-Sinai Medical Center
- Investigators
- Florian Rader, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612701
- Sponsor's protocol ID
- Pro00041957
- Status last verified
- Feb 2021
- First submitted
- 17 Nov 2015
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-Cigarette Aerosol, Conventional Cigarette Smoke, and Myocardial Perfusion
- ClinicalTrials.gov ID
- NCT02612701
- Acronym / sponsor ID
- Pro00041957
- Conditions
- Coronary Artery Disease, Myocardial Perfusion
- Keywords
- Myocardial perfusion, Electronic cigarettes, Cigarettes, Cigarette smoking
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the pandemic we decided to terminate this project.
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- Oct 2020 (actual)
- First posted
- 24 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cigarettes | Experimental | Other: CigarettesHealthy chronic dual cigarette and e-cigarette smokers will undergo myocardial contrast echocardiography before and after smoking two standard cigarettes |
| E-cigarettes (nicotine free e-liquid) | Experimental | Other: 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. |
| E-cigarettes (low nicotine e-liquid) | Experimental | Other: 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. |
| E-cigarettes (high nicotine e-liquid) | Experimental | Other: 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CigarettesSubjects will smoke a standard cigarette (yield: tar 12 mg, nicotine 1 mg) | Other | Cigarettes |
| E-cigarettes (nicotine free e-liquid)Subjects will smoke nicotine free e-liquid with an e-cigarette. | Other | E-cigarettes (nicotine free e-liquid) |
| E-cigarettes (low nicotine e-liquid)Subjects will smoke low nicotine (4-6 mg/mL) e-liquid with an e-cigarette. | Other | E-cigarettes (low nicotine e-liquid) |
| E-cigarettes (high nicotine e-liquid)Subjects will smoke low nicotine (18-24 mg/mL) e-liquid with an e-cigarette. | Other | E-cigarettes (high nicotine e-liquid) |
Primary outcome
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
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
Results and safety
The study was stopped early (reason given: Due to the pandemic we decided to terminate this project.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florian Rader, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cigarettes, E-cigarettes (nicotine free e-liquid) and E-cigarettes (low nicotine e-liquid) in people with Coronary Artery Disease and Myocardial Perfusion, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to the pandemic we decided to terminate this project.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial Perfusion (change in microvascular flux rate from baseline at 30 minutes) (time frame: Baseline and 30 minutes after smoking). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.