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Vascular EffectS of regUlar Cigarettes Versus electronIc Cigarette USe (VESUVIUS)

Primary Purpose

Vascular Diseases

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
electronic cigarette + 16mg nicotine & flavor
electronic cigarette + 0mg nicotine & flavor
Tobacco cigarette
Sponsored by
University of Dundee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Vascular Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • University of Dundee

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

tobacco cigarette

e.cigarettes + 16mg nicotine & flavor

e.cigarettes + 0mg nicotine & flavour

Arm Description

Intervention: tobacco cigarettes min 15/day

Intervention: One flavoured electronic cigarette 16mg nicotine/day

Intervention: One electronic cigarette with flavour +0mg nicotine/day

Outcomes

Primary Outcome Measures

Change in Flow mediated Dilation (FMD) between the TC group and the EC-nicotine and EC-nicotine free groups

Secondary Outcome Measures

Change in FMD between EC-nicotine and EC-nicotine free groups
Change in FMD between TC and EC groups combined
Change in oxidised LDL between the TC, EC-nicotine free and EC-nicotine groups
Change in PAI-1 between the TC, EC-nicotine free and EC-nicotine groups
Change in hs-CRP between the TC, EC-nicotine free and EC-nicotine groups
Change in Pulse Wave Velocity between the TC group and the EC-nicotine free groups.
Change in tPA between the TC, EC-nicotine free and EC-nicotine groups
Change in Augmentation Index@75bpm between the TC group,EC-nicotine and the EC-nicotine free groups

Full Information

First Posted
August 22, 2016
Last Updated
February 2, 2019
Sponsor
University of Dundee
Collaborators
NHS Tayside, British Heart Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02878421
Brief Title
Vascular EffectS of regUlar Cigarettes Versus electronIc Cigarette USe
Acronym
VESUVIUS
Official Title
Vascular Effects of Regular Cigarettes Versus electronIc Cigarette Use
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
August 18, 2016 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
July 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Dundee
Collaborators
NHS Tayside, British Heart Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Diseases

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tobacco cigarette
Arm Type
Active Comparator
Arm Description
Intervention: tobacco cigarettes min 15/day
Arm Title
e.cigarettes + 16mg nicotine & flavor
Arm Type
Active Comparator
Arm Description
Intervention: One flavoured electronic cigarette 16mg nicotine/day
Arm Title
e.cigarettes + 0mg nicotine & flavour
Arm Type
Active Comparator
Arm Description
Intervention: One electronic cigarette with flavour +0mg nicotine/day
Intervention Type
Device
Intervention Name(s)
electronic cigarette + 16mg nicotine & flavor
Other Intervention Name(s)
vapourlites, e.cigarette
Intervention Description
comparison of different strengths of nicotine
Intervention Type
Other
Intervention Name(s)
electronic cigarette + 0mg nicotine & flavor
Other Intervention Name(s)
vapourlites, e.cigarette
Intervention Description
comparison of different strengths of nicotine
Intervention Type
Other
Intervention Name(s)
Tobacco cigarette
Other Intervention Name(s)
Traditional cigarette, any brand
Intervention Description
Participant to remain on traditional cigarettes for 28 days
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Change in FMD between EC-nicotine and EC-nicotine free groups
Time Frame
Baseline and 1 month
Title
Change in FMD between TC and EC groups combined
Time Frame
Baseline and 1 month
Title
Change in oxidised LDL between the TC, EC-nicotine free and EC-nicotine groups
Time Frame
Baseline and 1 month
Title
Change in PAI-1 between the TC, EC-nicotine free and EC-nicotine groups
Time Frame
Baseline and 1 month
Title
Change in hs-CRP between the TC, EC-nicotine free and EC-nicotine groups
Time Frame
Baseline and 1 month
Title
Change in Pulse Wave Velocity between the TC group and the EC-nicotine free groups.
Time Frame
Baseline and 1 month
Title
Change in tPA between the TC, EC-nicotine free and EC-nicotine groups
Time Frame
Baseline and 1 month
Title
Change in Augmentation Index@75bpm between the TC group,EC-nicotine and the EC-nicotine free groups
Time Frame
Baseline and 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob George
Organizational Affiliation
University of Dundee
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Dundee
City
Dundee
State/Province
Tayside
ZIP/Postal Code
DD1 9SY
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31740017
Citation
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.
Results Reference
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Vascular EffectS of regUlar Cigarettes Versus electronIc Cigarette USe

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