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
- 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
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Tayside
-
Dundee, Tayside, Det Forenede Kongerige, DD1 9SY
- University of Dundee
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: tobacco cigarette
Intervention: tobacco cigarettes min 15/day
|
Participant to remain on traditional cigarettes for 28 days
Andre navne:
|
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Aktiv komparator: e.cigarettes + 16mg nicotine & flavor
Intervention: One flavoured electronic cigarette 16mg nicotine/day
|
comparison of different strengths of nicotine
Andre navne:
|
|
Aktiv komparator: e.cigarettes + 0mg nicotine & flavour
Intervention: One electronic cigarette with flavour +0mg nicotine/day
|
comparison of different strengths of nicotine
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in Flow mediated Dilation (FMD) between the TC group and the EC-nicotine and EC-nicotine free groups
Tidsramme: Baseline and 1 month
|
Baseline and 1 month
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in FMD between EC-nicotine and EC-nicotine free groups
Tidsramme: Baseline and 1 month
|
Baseline and 1 month
|
|
Change in FMD between TC and EC groups combined
Tidsramme: Baseline and 1 month
|
Baseline and 1 month
|
|
Change in oxidised LDL between the TC, EC-nicotine free and EC-nicotine groups
Tidsramme: Baseline and 1 month
|
Baseline and 1 month
|
|
Change in PAI-1 between the TC, EC-nicotine free and EC-nicotine groups
Tidsramme: Baseline and 1 month
|
Baseline and 1 month
|
|
Change in hs-CRP between the TC, EC-nicotine free and EC-nicotine groups
Tidsramme: Baseline and 1 month
|
Baseline and 1 month
|
|
Change in Pulse Wave Velocity between the TC group and the EC-nicotine free groups.
Tidsramme: Baseline and 1 month
|
Baseline and 1 month
|
|
Change in tPA between the TC, EC-nicotine free and EC-nicotine groups
Tidsramme: Baseline and 1 month
|
Baseline and 1 month
|
|
Change in Augmentation Index@75bpm between the TC group,EC-nicotine and the EC-nicotine free groups
Tidsramme: Baseline and 1 month
|
Baseline and 1 month
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Jacob George, University of Dundee
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2014CV10
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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