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

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

1. Switch to electronic cigarettes containing nicotine plus flavor
2. 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

Study Overview

• Status: Completed
• Conditions: Vascular Diseases
• Intervention / Treatment: Other: Tobacco cigarette; Device: electronic cigarette + 16mg nicotine & flavor; Other: electronic cigarette + 0mg nicotine & flavor

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 Type: Interventional
• Enrollment (Actual): 145
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Tayside
    • Dundee, Tayside, United Kingdom, DD1 9SY
      • University of Dundee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: tobacco cigarette; Intervention: tobacco cigarettes min 15/day	Other: Tobacco cigarette; Participant to remain on traditional cigarettes for 28 days; Other Names: Traditional cigarette, any brand
Active Comparator: e.cigarettes + 16mg nicotine & flavor; Intervention: One flavoured electronic cigarette 16mg nicotine/day	Device: electronic cigarette + 16mg nicotine & flavor; comparison of different strengths of nicotine; Other Names: vapourlites; e.cigarette
Active Comparator: e.cigarettes + 0mg nicotine & flavour; Intervention: One electronic cigarette with flavour +0mg nicotine/day	Other: electronic cigarette + 0mg nicotine & flavor; comparison of different strengths of nicotine; Other Names: vapourlites; e.cigarette

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Flow mediated Dilation (FMD) between the TC group and the EC-nicotine and EC-nicotine free groups	Baseline and 1 month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Dundee
• Collaborators: British Heart Foundation; NHS Tayside
• Investigators: Principal Investigator: Jacob George, University of Dundee

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2016
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: August 22, 2016
• First Submitted That Met QC Criteria: August 24, 2016
• First Posted (Estimate): August 25, 2016

Study Record Updates

• Last Update Posted (Actual): February 6, 2019
• Last Update Submitted That Met QC Criteria: February 2, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 2014CV10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED