Vascular EffectS of regUlar Cigarettes Versus electronIc Cigarette USe

Vascular Diseases Clinical Trial

— VESUVIUS  

Official title:

Vascular Effects of Regular Cigarettes Versus electronIc Cigarette Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02878421
• Other study ID #: 2014CV10
• Status: Completed
• Phase: N/A
• Start date: August 18, 2016
• Est. completion date: July 31, 2018

Study information

• Verified date: February 2019
• Source: University of Dundee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Vascular Diseases

Intervention

Device:
• electronic cigarette + 16mg nicotine & flavor
comparison of different strengths of nicotine

Other:
• electronic cigarette + 0mg nicotine & flavor
comparison of different strengths of nicotine
• Tobacco cigarette
Participant to remain on traditional cigarettes for 28 days

Locations

Country	Name	City	State
United Kingdom	University of Dundee	Dundee	Tayside

Sponsors (3)

Lead Sponsor	Collaborator
University of Dundee	British Heart Foundation, NHS Tayside

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Flow mediated Dilation (FMD) between the TC group and the EC-nicotine and EC-nicotine free groups		Baseline and 1 month
Secondary	Change in FMD between EC-nicotine and EC-nicotine free groups		Baseline and 1 month
Secondary	Change in FMD between TC and EC groups combined		Baseline and 1 month
Secondary	Change in oxidised LDL between the TC, EC-nicotine free and EC-nicotine groups		Baseline and 1 month
Secondary	Change in PAI-1 between the TC, EC-nicotine free and EC-nicotine groups		Baseline and 1 month
Secondary	Change in hs-CRP between the TC, EC-nicotine free and EC-nicotine groups		Baseline and 1 month
Secondary	Change in Pulse Wave Velocity between the TC group and the EC-nicotine free groups.		Baseline and 1 month
Secondary	Change in tPA between the TC, EC-nicotine free and EC-nicotine groups		Baseline and 1 month
Secondary	Change in Augmentation Index@75bpm between the TC group,EC-nicotine and the EC-nicotine free groups		Baseline and 1 month