Acute effects of electronic cigarette on myocardial function
| ISRCTN | ISRCTN16974547 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16974547 |
| Secondary identifying numbers | N/A |
- Submission date
- 30/07/2013
- Registration date
- 14/08/2013
- Last edited
- 10/07/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
ESLIN 12
LAMIA
35100
Greece
| kfarsalinos@gmail.com |
Study information
| Study design | Case-control study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Case-control study |
| Study setting(s) | Other |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Acute effects of using an electronic nicotine-delivery device (electronic cigarette) on myocardial function: comparison with the effects of regular cigarettes |
| Study objectives | 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(s) | The study was approved by the Onassis Cardiac Surgery Center ethics committee, Greece |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 10/02/2012 |
| Completion date | 25/08/2012 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 80 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 10/02/2012 |
| Date of final enrolment | 01/05/2012 |
Locations
Countries of recruitment
- Greece
Study participating centre
35100
Greece
Sponsor information
Hospital/treatment centre
356, Sygrou Ave.
Kallithea
176 74
Greece
| kfarsalinos@gmail.com | |
"ROR" |
https://ror.org/02gan0k07 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 23/06/2014 | Yes | No |
