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Acute effects of electronic cigarette on myocardial function
ISRCTN ISRCTN16974547
DOI 10.1186/ISRCTN16974547
ClinicalTrials.gov identifier
EudraCT number
Public title Acute effects of electronic cigarette on myocardial function
Scientific title Acute effects of using an electronic nicotine-delivery device (electronic cigarette) on myocardial function: comparison with the effects of regular cigarettes
Acronym N/A
Serial number at source N/A
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.
Lay 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
Ethics approval The study was approved by the Onassis Cardiac Surgery Center ethics committee, Greece.
Study design Case-control study
Countries of recruitment Greece
Disease/condition/study domain Smoking
Participants - 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)
Participants - 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
Anticipated start date 10/02/2012
Anticipated end date 25/08/2012
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 80
Interventions 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.
Primary outcome measure(s) Changes in left ventricular myocardial diastolic function after smoking and electronic cigarette use assessed by echocardiography, 5 minutes after the intervention
Secondary outcome measure(s) Hemodynamic changes
Sources of funding Investigator, initiated and funded
Trial website
Publications
Contact name Dr  Konstantinos  Farsalinos
  Address ESLIN 12
  City/town LAMIA
  Zip/Postcode 35100
  Country Greece
  Email kfarsalinos@gmail.com
Sponsor Onassis Cardiac Surgery Center (Greece)
  Address 356, Sygrou Ave.
  City/town Kallithea
  Zip/Postcode 176 74
  Country Greece
  Email kfarsalinos@gmail.com
Date applied 30/07/2013
Last edited 14/08/2013
Date ISRCTN assigned 14/08/2013
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