Plain English Summary
Background and study aims
Cigarette smoking has well-established severe side effects on the functioning of the heart, specifically left ventricular myocardial function. Electronic cigarettes have been recently marketed as an alternative to smoking. However, no studies have evaluated the clinical effects of electronic cigarette use. Therefore, the purpose of this study was to find out the effects of electronic cigarette use on left ventricular myocardial function and to compare them with the effects of cigarette smoke.
Who can participate?
Volunteers, healthy smokers and healthy electronic cigarette users can participate in this study.
What does the study involve?
Smokers and electronic cigarette users are the two groups evaluated. An initial heart test (echocardiogram) will be performed in smokers after at least 8 hours of refraining from smoking, alcohol, food and caffeine intake. Then, they will smoke 1 cigarette in 5 minutes and a second echocardiogram will be performed. In electronic cigarette users, an echocardiogram will be performed after at least 8 hours of refraining from electronic cigarette use, alcohol, food and caffeine intake. Subsequently, they will be asked to use an electronic cigarette for 7 minutes. A new echocardiogram will be performed. The two echocardiograms will be compared in both of the groups.
What are the possible benefits and risks of participating?
By taking part in this study there are no risks of physical injury or harm. Increase in anxiety may be experienced due to not smoking and not using electronic cigarettes for 8 hours. Nicotine craving symptoms may be expected, but will be relieved after the initial echocardiogram.
Where is the study run from?
Onassis Cardiac Surgery Center, Greece.
When is the study starting and how long is it expected to run for?
The study started in December 2011 and recruitment was completed in May 2012.
Who is funding the study?
Investigator initiated and funded.
Who is the main contact?
Dr Konstantinos Farsalinos
kfarsalinos@gmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Konstantinos Farsalinos
ORCID ID
Contact details
ESLIN 12
LAMIA
35100
Greece
-
kfarsalinos@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acute effects of using an electronic nicotine-delivery device (electronic cigarette) on myocardial function: comparison with the effects of regular cigarettes
Acronym
Study hypothesis
The purpose of this study was to examine the immediate effects of electronic cigarette use on left ventricular function and compare them with the effects of cigarette smoking.
Ethics approval
The study was approved by the Onassis Cardiac Surgery Center ethics committee, Greece
Study design
Case-control study
Primary study design
Interventional
Secondary study design
Case-control study
Trial setting
Other
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Smoking
Intervention
We asked smokers to smoke 1 tobacco cigarette for 5 minutes and electronic cigarette users to use an electronic cigarette device for 7 minutes. Echocardiograms were performed, before and after this intervention, to evaluate the left ventricular systolic and diastolic function and examine the possibility of changes induced by the intervention.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Changes in left ventricular myocardial diastolic function after smoking and electronic cigarette use assessed by echocardiography, 5 minutes after the intervention
Secondary outcome measures
Hemodynamic changes
Overall trial start date
10/02/2012
Overall trial end date
25/08/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Clinically healthy individuals
2. No history of cardiovascular or other disease
3. Not taking medications
4. Not pregnant
5. No risk factors for cardiovascular disease (besides smoking)
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
80
Participant exclusion criteria
1. Electrocardiographic abnormalities
2. Echocardiographic signs of myocardial systolic dysfuntion
3. Low ejection fraction
4. More than mild valve regurgitation or any other valve disease
Recruitment start date
10/02/2012
Recruitment end date
01/05/2012
Locations
Countries of recruitment
Greece
Trial participating centre
ESLIN 12
LAMIA
35100
Greece
Sponsor information
Organisation
Onassis Cardiac Surgery Center (Greece)
Sponsor details
356
Sygrou Ave.
Kallithea
176 74
Greece
-
kfarsalinos@gmail.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24958250