Condition category
Mental and Behavioural Disorders
Date applied
30/07/2013
Date assigned
14/08/2013
Last edited
10/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24958250

Publication citations

Additional files

Editorial Notes