The Effects of Electronic Cigarette Smoking on the Arterial Wall and Endothelial Glycocalyx Properties of Smokers
調査の概要
詳細な説明
Two smoker groups matched for age and sex will be assessed:
- a group of 30 current smokers with no diagnosed cardiovascular disease as the control group for chronic phase
- a group of 30 current smokers with no diagnosed cardiovascular disease who will be using the electronic cigarette with nicotine for 1 month
In the acute phase all 60 smokers will undergo a "sham" smoking for 7 minutes. Afterwards 30 out of 60 smokers will be randomized to smoke either a normal cigarette or an electronic cigarette with nicotine and after a 60 minute washout period these subjects will be crossed over to the alternate mode of smoking (electronic with nicotine or normal cigarette respectively).
The remaining 30 smokers will be randomized to smoke either a normal cigarette or an electronic cigarette without nicotine and after a 60 minute washout period these subjects will be crossed over to the alternate mode of smoking (electronic without nicotine or normal cigarette respectively.
After the completion of the acute phase all 60 smokers will start the use of an electronic cigarette for one month.
In the acute phase, measurements will be performed at baseline, after sham smoking and after smoking of the normal or electronic cigarette (with or without nicotine). The chronic phase measurements will be performed 1 month after use electronic cigarette with nicotine. Thirty current smokers of similar age and sex will serve as controls and will have measurements at baseline and 1 month after baseline assessment. The nicotine concentration of the electronic cigarette fluid used during both phases will be 12 mg/dL, while the participants will be allowed to use their cigarette of preference in the acute phase. In both phases we will assess a) the aortic pulse wave velocity (PWV) and augmentation index (AIx) by Arteriograph and Complior; b) the perfusion boundary region of the sublingual arterial microvessels using Sideview, Darkfield imaging (Microscan, Glycocheck); c) the exhaled carbon monoxide (CO) level (parts per million -ppm) as a smoking status marker; d) the vital signs; e) an electrocardiogram; and f) plasma levels of C- reactive protein (CRP), transforming growth factor-b (TGF-b), lipoprotein associated phospholipase A2 (LP- LPA2), tumor necrosis factor- α (TNF-α), interleukins 6 and 10 (IL-6 and -10), procollagen propeptide type III (PIIINP), matrix metalloproteinase 2 and 9 (MMP-2 and -9), and macrophage-colony stimulating factor (MCSF), malondialdehyde (MDA) and protein carbonyls (PC) and platelet function tests using the novel Platelet Function Analyzer PFA-100 and the traditional Light Transmission Aggregometry (LTA)
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Attiki
-
Athens、Attiki、ギリシャ、12462
- 募集
- ''Attikon'' University General Hospital
-
コンタクト:
- Ignatios Ikonomidis, MD
- 電話番号:00302105831264
-
-
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:
- Active conventional cigarette smoker
Exclusion Criteria:
- Health condition adversely affected by smoking, history or presence of cardiovascular disease
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:防止
- 割り当て:ランダム化
- 介入モデル:クロスオーバー割り当て
- マスキング:4倍
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:Electronic cigarette with or without nicotine
Electronic cigarette assisted cessation program
|
Smoking of electronic cigarette
|
|
アクティブコンパレータ:喫煙者管理
従来の喫煙継続
|
Smoking tobacco cigarette
|
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Acute electronic cigarette vaping effects on arterial stiffness.
時間枠:7 minutes
|
Acute electronic cigarette vaping effects on arterial stiffness as assessed by pulse wave velocity (PWV, m/sec).
PWV (m/sec) was measured by using tonometry by Complior (Alam Medical, Vincennes, France).
Two non-invasive pressure sensors were used to record the carotid and femoral waveforms and the distance between the two arterial sites was measured with a tape measure.
|
7 minutes
|
|
Acute electronic cigarette vaping effects on endothelial integrity.
時間枠:7 minutes
|
Acute electronic cigarette vaping effects on endothelial integrity as assessed by measuring endothelial glycocalyx thickness.
We measured the perfused boundary region (PBR) of the sublingual arterial microvessels (ranged from 5 to 25 μm) using Sidestream Darkfield Imaging (Microscan, Glycocheck, Microvascular Health Solutions Inc., Salt Lake City, UT, USA).
|
7 minutes
|
|
Chronic electronic cigarette vaping effects on arterial stiffness.
時間枠:1 month
|
Chronic electronic cigarette vaping effects on arterial stiffness, as assessed by pulse wave velocity (PWV, m/sec).
PWV (m/sec) was measured by using tonometry by Complior (Alam Medical, Vincennes, France).
Two non-invasive pressure sensors were used to record the carotid and femoral waveforms and the distance between the two arterial sites was measured with a tape measure.
|
1 month
|
|
Chronic electronic cigarette vaping effects on endothelial integrity.
時間枠:1 month
|
Chronic electronic cigarette vaping effects on endothelial integrity as assessed by measuring endothelial glycocalyx thickness.
We measured the perfused boundary region (PBR) of the sublingual arterial microvessels (ranged from 5 to 25 μm) using Sidestream Darkfield Imaging (Microscan, Glycocheck, Microvascular Health Solutions Inc., Salt Lake City, UT, USA).
|
1 month
|
|
Chronic electronic cigarette vaping effects on platelet aggregation.
時間枠:1 month
|
Chronic electronic cigarette vaping effects on platelet function as assessed by Light Transmission Aggregometry (LTA).
We measured both maximum (peak) and late platelet aggregation (%) (at 6 minutes) after addition of epinephrine (as stimulant) in platelet rich plasma.The 100% line was set using platelet poor plasma and a 0% baseline established with platelet rich plasma before addition of the agonist(epinephrine). Platelet aggregation is experssed as % of the 100% line
|
1 month
|
|
Chronic electronic cigarette vaping effects on high-shear stress-dependent platelet function.
時間枠:1 month
|
Chronic electronic cigarette vaping effects on high-shear stress-dependent platelet function as assesed by PFA-100.
The instrument estimates the ability of platelets activated in a high shear environment to occlude an aperture in a membrane coated with collagen and epinephrine (CEPI).The time taken for flow across the membrane to stop (closure time, CT, seconds) is recorded as measure of platelet function.
Platelet adhesion and aggregation following a vascular injury is simulated in vitro by PFA.
|
1 month
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Ignatios Ikonomidis, Dr、Attikon Hospital
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 (予想される)
研究の完了 (予想される)
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
本研究に関する用語
その他の研究ID番号
- 698/11-3-15
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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