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
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Tayside
-
Dundee、Tayside、イギリス、DD1 9SY
- University of Dundee
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：tobacco cigarette
Intervention: tobacco cigarettes min 15/day
|
Participant to remain on traditional cigarettes for 28 days
他の名前：
|
|
アクティブコンパレータ：e.cigarettes + 16mg nicotine & flavor
Intervention: One flavoured electronic cigarette 16mg nicotine/day
|
comparison of different strengths of nicotine
他の名前：
|
|
アクティブコンパレータ：e.cigarettes + 0mg nicotine & flavour
Intervention: One electronic cigarette with flavour +0mg nicotine/day
|
comparison of different strengths of nicotine
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Change in Flow mediated Dilation (FMD) between the TC group and the EC-nicotine and EC-nicotine free groups
時間枠：Baseline and 1 month
|
Baseline and 1 month
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Change in FMD between EC-nicotine and EC-nicotine free groups
時間枠：Baseline and 1 month
|
Baseline and 1 month
|
|
Change in FMD between TC and EC groups combined
時間枠：Baseline and 1 month
|
Baseline and 1 month
|
|
Change in oxidised LDL between the TC, EC-nicotine free and EC-nicotine groups
時間枠：Baseline and 1 month
|
Baseline and 1 month
|
|
Change in PAI-1 between the TC, EC-nicotine free and EC-nicotine groups
時間枠：Baseline and 1 month
|
Baseline and 1 month
|
|
Change in hs-CRP between the TC, EC-nicotine free and EC-nicotine groups
時間枠：Baseline and 1 month
|
Baseline and 1 month
|
|
Change in Pulse Wave Velocity between the TC group and the EC-nicotine free groups.
時間枠：Baseline and 1 month
|
Baseline and 1 month
|
|
Change in tPA between the TC, EC-nicotine free and EC-nicotine groups
時間枠：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
時間枠：Baseline and 1 month
|
Baseline and 1 month
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Jacob George、University of Dundee
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
血管疾患の臨床試験
-
Cliniques universitaires Saint-Luc- Université...完了
Tobacco cigaretteの臨床試験
-
R.J. Reynolds Vapor CompanyCovance; R.J. Reynolds Tobacco Company; MAS (Materials Analytical Services), LLC完了
-
H. Lee Moffitt Cancer Center and Research InstituteJames and Esther King Biomedical Research Program募集
-
R.J. Reynolds Vapor CompanyRAI Services Company; Davita Clinical Research完了