Condition category
Not Applicable
Date applied
23/08/2016
Date assigned
27/09/2016
Last edited
27/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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 flavor. 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 June 2018

Who is funding the study?
British Heart Foundation (UK)

Who is the main contact?
1. Mrs Pippa Hopkinson
2. Dr Jacob George

Trial website

Contact information

Type

Public

Primary contact

Mrs Pippa Hopkinson

ORCID ID

Contact details

Mailbox 2
CCDM
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom

Type

Scientific

Additional contact

Dr Jacob George

ORCID ID

http://orcid.org/0000-0001-8154-8278

Contact details

Mailbox 2
CCDM
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT02878421

Protocol/serial number

2014CV10

Study information

Scientific title

Vascular EffectS of regUlar cigarettes Versus electronIc cigarette USe: a randomised controlled trial

Acronym

VESUVIUS

Study hypothesis

Endothelial function will be improved on electronIc cigarettes (EC) compared to tobacco cigarettes (TC) when measured by flow-mediated dilatation (FMD).

Ethics approval

East of Scotland Research Ethics Service (EoSRES), 26/07/2016, REC ref: 16/ES/0087, Protocol number: 2014CV10, IRAS project ID: 207653

Study design

Single-centre three-cohort parallel-group randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/08/2016

Overall trial end date

30/06/2018

Reason abandoned

Eligibility

Participant 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

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

135

Participant 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

Recruitment start date

01/09/2016

Recruitment end date

30/06/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom

Sponsor information

Organisation

University of Dundee

Sponsor details

Ninewells Hospital & Medical School
TASC R & D Office
Residency Block Level 3
George Pirie Way
Dundee
DD1 9SY
United Kingdom

Sponsor type

University/education

Website

tasc-research.org

Funders

Funder type

Charity

Funder name

British Heart Foundation

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes