Clinical trial NCT02878421: Vascular EffectS of regUlar Cigarettes Versus electronIc Cigarette USe
Official title: Vascular Effects of Regular Cigarettes Versus electronIc Cigarette Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Diseases
Lead sponsor: University of Dundee
Sponsor class: OTHER
Collaborators: name: NHS Tayside
name: British Heart Foundation
First posted: 2016-08-25
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

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

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.

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.

Primary outcomes:
measure: Change in Flow mediated Dilation (FMD) between the TC group and the EC-nicotine and EC-nicotine free groups
timeFrame: Baseline and 1 month
Secondary outcomes:
measure: Change in FMD between EC-nicotine and EC-nicotine free groups
timeFrame: Baseline and 1 month
measure: Change in FMD between TC and EC groups combined
timeFrame: Baseline and 1 month
measure: Change in oxidised LDL between the TC, EC-nicotine free and EC-nicotine groups
timeFrame: Baseline and 1 month
measure: Change in PAI-1 between the TC, EC-nicotine free and EC-nicotine groups
timeFrame: Baseline and 1 month
measure: Change in hs-CRP between the TC, EC-nicotine free and EC-nicotine groups
timeFrame: Baseline and 1 month
measure: Change in Pulse Wave Velocity between the TC group and the EC-nicotine free groups.
timeFrame: Baseline and 1 month
measure: Change in tPA between the TC, EC-nicotine free and EC-nicotine groups
timeFrame: Baseline and 1 month
measure: Change in Augmentation Index@75bpm between the TC group,EC-nicotine and the EC-nicotine free groups
timeFrame: Baseline and 1 month
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: University of Dundee
state: Tayside
Study officials:
affiliation: University of Dundee
name: Jacob George
role: PRINCIPAL_INVESTIGATOR
References:
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.