Vascular DiseasesVESUVIUSNCT02878421
Vascular EffectS of regUlar Cigarettes Versus electronIc Cigarette USe
A study testing electronic cigarette + 16mg nicotine & flavor, electronic cigarette + 0mg nicotine & flavor and Tobacco cigarette in people with Vascular Diseases, run by University of Dundee at 1 site in United Kingdom.
Trial summary
The purpose of this study is to assess the effects of electronic cigarettes-nicotine and electronic cigarette-nicotine free on endothelial function as compared to traditional cigarettes. Due to ethical reasons, we cannot fully randomise all particpants to the three arms. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vascular Diseases
- What is being tested?
- electronic cigarette + 16mg nicotine & flavor, electronic cigarette + 0mg nicotine & flavor and Tobacco cigarette
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Aug 2016to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 years and over
- Currently smoking ≥15 full strength tobacco cigarettes per day for at least 2 years, or roll-up tobacco equivalent (cigar or pipe smokers not included).
- Willing to stop tobacco cigarettes for period of study if required
- Willing not to use electronic cigarettes if required
- Able to give informed consent
Who cannot join
- Pregnant or lactating.
- Women of childbearing potential who do not abstain from sex or use effective contraception.
- On current prescribed medication for cardiovascular disease.
- History of cardiovascular disease (excluding hypertension), diabetes, active malignance or chronic renal disease.
- Nut allergy
- Participation in another clinical trial (other than observational trials and registries) with an investigational product and/or intervention within 30 days before visit 1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vascular Effects of Regular Cigarettes Versus electronIc Cigarette Use
The purpose of this study is to assess the effects of electronic cigarettes-nicotine and electronic cigarette-nicotine free on endothelial function as compared to traditional cigarettes. Due to ethical reasons, we cannot fully randomise all particpants to the three arms.
Participants who wish to quit smoking will be randomized to
- Switch to electronic cigarettes containing nicotine plus flavor
- Switch to electronic cigarettes containing flavor alone Those who do not wish to quit smoking will continue on the Tobacco Cigarette arm Treatment period will be 28 days
Read the detailed description
Electronic cigarettes (EC) are gaining popularity as an alternative to Traditional Cigarettes (TC). Despite not containing all the harmful substances seen in TC, EC are known to contain impurities that may have a detrimental impact on human health. The effects of ECs compared with TC on vascular function, inflammation and oxidative stress are unknown. It is increasingly recognised that nicotine itself has significant atherothrombotic effects. Therefore, clinicians are unable to confidently recommend ECs as a less risky alternative to TC.
Hypothesis: Endothelial function will be improved on EC compared to TC when measured by flow mediated dilatation (FMD).
Potential benefit: This study will provide further information on the potential use these devices and the risks and/or benefits associated with them, specifically in relation to vascular health.
- Conditions
- Vascular Diseases
- Being tested
- electronic cigarette + 16mg nicotine & flavor, electronic cigarette + 0mg nicotine & flavor, Tobacco cigarette
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electronic cigarette + 16mg nicotine & flavorDevice
Also called vapourlites, e.cigarette
comparison of different strengths of nicotine
electronic cigarette + 0mg nicotine & flavorOther
Also called vapourlites, e.cigarette
comparison of different strengths of nicotine
Tobacco cigaretteOther
Also called Traditional cigarette, any brand
Participant to remain on traditional cigarettes for 28 days
| Study group | Role | What they receive |
|---|---|---|
| tobacco cigarette | Active comparator | Intervention: tobacco cigarettes min 15/day Receives: Other: Tobacco cigarette |
| e.cigarettes + 16mg nicotine & flavor | Active comparator | Intervention: One flavoured electronic cigarette 16mg nicotine/day Receives: Device: electronic cigarette + 16mg nicotine & flavor |
| e.cigarettes + 0mg nicotine & flavour | Active comparator | Intervention: One electronic cigarette with flavour +0mg nicotine/day Receives: Other: electronic cigarette + 0mg nicotine & flavor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Flow mediated Dilation (FMD) between the TC group and the EC-nicotine and EC-nicotine free groups
Measured: Baseline and 1 month
Secondary outcomes (8)
Change in FMD between EC-nicotine and EC-nicotine free groups
Measured: Baseline and 1 month
Change in FMD between TC and EC groups combined
Measured: Baseline and 1 month
Change in oxidised LDL between the TC, EC-nicotine free and EC-nicotine groups
Measured: Baseline and 1 month
Change in PAI-1 between the TC, EC-nicotine free and EC-nicotine groups
Measured: Baseline and 1 month
Change in hs-CRP between the TC, EC-nicotine free and EC-nicotine groups
Measured: Baseline and 1 month
Change in Pulse Wave Velocity between the TC group and the EC-nicotine free groups.
Measured: Baseline and 1 month
Change in tPA between the TC, EC-nicotine free and EC-nicotine groups
Measured: Baseline and 1 month
Change in Augmentation Index@75bpm between the TC group,EC-nicotine and the EC-nicotine free groups
Measured: Baseline and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study start18 Aug 2016
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Tayside, British Heart Foundation
- Responsible party
- Principal investigator, Professor. Jacob George, University of Dundee
- Investigators
- Jacob George, Principal investigator, University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878421
- Sponsor's protocol ID
- 2014CV10
- Acronym
- VESUVIUS
- Status last verified
- Feb 2019
- First submitted
- 22 Aug 2016
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
George J, Hussain M, Vadiveloo T, Ireland S, Hopkinson P, Struthers AD, Donnan PT, Khan F, Lang CC. Cardiovascular Effects of Switching From Tobacco Cigarettes to Electronic Cigarettes. J Am Coll Cardiol. 2019 Dec 24;74(25):3112-3120. doi: 10.1016/j.jacc.2019.09.067. Epub 2019 Nov 15.
PubMed 31740017
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Effects of Regular Cigarettes Versus electronIc Cigarette Use
- ClinicalTrials.gov ID
- NCT02878421
- Acronym / sponsor ID
- VESUVIUS / 2014CV10
- Conditions
- Vascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Collaborators
- NHS Tayside, British Heart Foundation
- Study start
- 18 Aug 2016 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 25 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effects of electronic cigarettes-nicotine and electronic cigarette-nicotine free on endothelial function as compared to traditional cigarettes. Due to ethical reasons, we cannot fully randomise all particpants to the three arms.
Participants who wish to quit smoking will be randomized to
- Switch to electronic cigarettes containing nicotine plus flavor
- Switch to electronic cigarettes containing flavor alone Those who do not wish to quit smoking will continue on the Tobacco Cigarette arm Treatment period will be 28 days
Detailed description
Electronic cigarettes (EC) are gaining popularity as an alternative to Traditional Cigarettes (TC). Despite not containing all the harmful substances seen in TC, EC are known to contain impurities that may have a detrimental impact on human health. The effects of ECs compared with TC on vascular function, inflammation and oxidative stress are unknown. It is increasingly recognised that nicotine itself has significant atherothrombotic effects. Therefore, clinicians are unable to confidently recommend ECs as a less risky alternative to TC.
Hypothesis: Endothelial function will be improved on EC compared to TC when measured by flow mediated dilatation (FMD).
Potential benefit: This study will provide further information on the potential use these devices and the risks and/or benefits associated with them, specifically in relation to vascular health.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tobacco cigarette | Active comparator | Other: Tobacco cigaretteIntervention: tobacco cigarettes min 15/day |
| e.cigarettes + 16mg nicotine & flavor | Active comparator | Device: electronic cigarette + 16mg nicotine & flavorIntervention: One flavoured electronic cigarette 16mg nicotine/day |
| e.cigarettes + 0mg nicotine & flavour | Active comparator | Other: electronic cigarette + 0mg nicotine & flavorIntervention: One electronic cigarette with flavour +0mg nicotine/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 years and over
- Currently smoking ≥15 full strength tobacco cigarettes per day for at least 2 years, or roll-up tobacco equivalent (cigar or pipe smokers not included).
- Willing to stop tobacco cigarettes for period of study if required
- Willing not to use electronic cigarettes if required
- Able to give informed consent
Key exclusion criteria (6 listed)
- Pregnant or lactating.
- Women of childbearing potential who do not abstain from sex or use effective contraception.
- On current prescribed medication for cardiovascular disease.
- History of cardiovascular disease (excluding hypertension), diabetes, active malignance or chronic renal disease.
- Nut allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electronic cigarette + 16mg nicotine & flavorAlso: vapourlites, e.cigarettecomparison of different strengths of nicotine | Device | e.cigarettes + 16mg nicotine & flavor |
| electronic cigarette + 0mg nicotine & flavorAlso: vapourlites, e.cigarettecomparison of different strengths of nicotine | Other | e.cigarettes + 0mg nicotine & flavour |
| Tobacco cigaretteAlso: Traditional cigarette, any brandParticipant to remain on traditional cigarettes for 28 days | Other | tobacco cigarette |
Primary outcome
Change in Flow mediated Dilation (FMD) between the TC group and the EC-nicotine and EC-nicotine free groups
Time frame: Baseline and 1 month
8 secondary outcomes
Change in FMD between EC-nicotine and EC-nicotine free groups
Time frame: Baseline and 1 month
Change in FMD between TC and EC groups combined
Time frame: Baseline and 1 month
Change in oxidised LDL between the TC, EC-nicotine free and EC-nicotine groups
Time frame: Baseline and 1 month
Change in PAI-1 between the TC, EC-nicotine free and EC-nicotine groups
Time frame: Baseline and 1 month
Change in hs-CRP between the TC, EC-nicotine free and EC-nicotine groups
Time frame: Baseline and 1 month
Change in Pulse Wave Velocity between the TC group and the EC-nicotine free groups.
Time frame: Baseline and 1 month
Change in tPA between the TC, EC-nicotine free and EC-nicotine groups
Time frame: Baseline and 1 month
Change in Augmentation Index@75bpm between the TC group,EC-nicotine and the EC-nicotine free groups
Time frame: Baseline and 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
- Derived from this study: PubMed 31740017George J, Hussain M, Vadiveloo T, Ireland S, Hopkinson P, Struthers AD, Donnan PT, Khan F, Lang CC. Cardiovascular Effects of Switching From Tobacco Cigarettes to Electronic Cigarettes. J Am Coll Cardiol. 2019 Dec 24;74(25):3112-3120. doi: 10.1016/j.jacc.2019.09.067. Epub 2019 Nov 15.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob George principal investigator
University of Dundee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electronic cigarette + 16mg nicotine & flavor, electronic cigarette + 0mg nicotine & flavor and Tobacco cigarette in people with Vascular Diseases, run by University of Dundee at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Flow mediated Dilation (FMD) between the TC group and the EC-nicotine and EC-nicotine free groups (time frame: Baseline and 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02878421, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2019.