Vascular effects of regular cigarettes versus electronIc cigarettes
| ISRCTN | ISRCTN59133298 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59133298 |
| ClinicalTrials.gov number | NCT02878421 |
| Secondary identifying numbers | 2014CV10 |
- Submission date
- 23/08/2016
- Registration date
- 27/09/2016
- Last edited
- 25/05/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Electronic cigarettes, also known as e-cigarettes or vaping, are being used by more and more people to help them stop smoking. There have been many claims in the media about the safety of e-cigarettes. E-cigarettes are sold on the principle that they are a much safer alternative to traditional cigarettes because they don’t contain harmful substances like tobacco and tar. However, most e-cigarettes, like traditional cigarettes, do contain nicotine which may be harmful to blood vessels. The aim of this study is to compare the blood vessel health of people using e-cigarettes containing nicotine, people using e-cigarettes without nicotine, and people smoking tobacco cigarettes.
Who can participate?
People aged 18 and over who currently smoke
What does the study involve?
Participants are randomly allocated into one of three groups. The first group continues smoking tobacco cigarettes (the participants' own). The second group switches to smoking electronic cigarettes containing nicotine and flavour. The third group switches to smoking electronic cigarettes containing flavour alone. Participants’ blood vessel health is assessed at the start of the study and after 28 days.
What are the possible benefits and risks of participating?
There may not be direct benefits to the participants except that all participants will be provided with smoking cessation advice and support at the end of the study. The procedure used to assess blood vessel health is called Flow Mediated Dilatation, which involves inflating a blood pressure cuff that may be uncomfortable. Patients are also required to provide blood samples to look for markers of blood vessel health.
Where is the study run from?
Ninewells Hospital and Medical School (UK)
When is the study starting and how long is it expected to run for?
August 2016 to November 2018
Who is funding the study?
British Heart Foundation (UK)
Who is the main contact?
1. Mrs Pippa Hopkinson
2. Dr Jacob George
Contact information
Public
Mailbox 2
CCDM
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom
Scientific
Mailbox 2
CCDM
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom
 ORCID ID |
0000-0001-8154-8278 |
|---|
Study information
| Study design | Single-centre three-cohort parallel-group randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Vascular EffectS of regUlar cigarettes Versus electronIc cigarette USe: a randomised controlled trial |
| Study acronym | VESUVIUS |
| Study objectives | Endothelial function will be improved on electronIc cigarettes (EC) compared to tobacco cigarettes (TC) when measured by flow-mediated dilatation (FMD). |
| Ethics approval(s) | East of Scotland Research Ethics Service (EoSRES), 26/07/2016, REC ref: 16/ES/0087, Protocol number: 2014CV10, IRAS project ID: 207653 |
| Health condition(s) or problem(s) studied | Smoking |
| Intervention | Randomisation will be carried out in a 1:1:1 fashion via a centrally controlled web-based GCP compliant randomisation system. To ensure balanced assignment across critical variables, a minimisation algorithm will be employed, using baseline age (≤40 years & >40 years) and smoking pack years (≤20 pack years & > 20 pack years). 1. Continue with tobacco cigarettes (participants' own) 2. Switch to electronic cigarettes containing 16mg nicotine plus flavour 3. Switch to electronic cigarettes containing flavour alone Treatment period 28 days (+/- 10 days) Endothelial function will be measured non-invasively at 0 and 4 weeks using the standard technique of flow mediated dilatation (FMD) of the brachial artery in response to hyperemia and to sublingual GTN. Brachial artery diameter and flow are determined by M mode and Doppler ultrasound. |
| Intervention type | Other |
| Primary outcome measure | Difference in flow-mediated dilation (a measure of endothelial dysfunction) between the traditional cigarette group and the electronic cigarette-nicotine-free groups at 0 and 4 weeks |
| Secondary outcome measures | 1. Difference in flow-mediated dilation (a measure of endothelial dysfunction) between electronic cigarette-16 mg nicotine and electronic cigarette-nicotine free groups at 0 and 4 weeks 2. Difference in Pulse Wave Velocity (a measure of arterial stiffness) between the traditional cigarette group and the electronic cigarette-nicotine free groups at 0 and 4 weeks 3. Difference in Augmentation Index@75bpm (a measure of arterial stiffness) between the traditional cigarette group and the electronic cigarette-nicotine free groups at 0 and 4 weeks |
| Overall study start date | 01/08/2016 |
| Completion date | 30/11/2018 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 135 |
| Total final enrolment | 145 |
| Key inclusion criteria | 1. Aged 18 years and over 2. Currently smoking ≥15 full strength tobacco cigarettes per day for at least 2 years, or roll-up tobacco equivalent (cigar or pipe smokers will not be included). 3. Willing to stop tobacco cigarettes for period of study if required 4. Willing not to use electronic cigarettes if required 5. Able to give informed consent |
| Key exclusion criteria | 1. Pregnant or lactating 2. Women of childbearing potential who do not abstain from sex or use effective contraception 3. On current prescribed medication for cardiovascular disease 4. History of cardiovascular disease (excluding hypertension), diabetes, active malignance or chronic renal disease 5. Nut allergy 6. Participation in another clinical trial (other than observational trials and registries) with an investigational product and/or intervention within 30 days before visit 1 |
| Date of first enrolment | 01/09/2016 |
| Date of final enrolment | 30/06/2018 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
DD1 9SY
United Kingdom
Sponsor information
University/education
Ninewells Hospital & Medical School
TASC R & D Office
Residency Block Level 3
George Pirie Way
Dundee
DD1 9SY
Scotland
United Kingdom
| Website | tasc-research.org |
|---|---|
"ROR" |
https://ror.org/03h2bxq36 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 24/12/2019 | 25/05/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
25/05/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
21/06/2019: The overall trial end date was changed from 30/06/2018 to 30/11/2018.
13/05/2019: Internal review.
26/10/2017: Internal review.
