Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00007930

Trial Description

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Title

Acute Effect of „electronic – cigarette“-use on vascular endothelial function

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Trial Acronym

VaPOR-Acute

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This study seeks to investigate wether short term exposure to e-cigarettes affects vascular function in smokers and non-smokers. While negative impact of cigarette smoke on blood vessels is well known, little is known on effects e-cigarettes. The study exposes non-smokers to 20 minutes of nicotine containing vapour and measures vessel function before and after.

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Brief Summary in Scientific Language

Smokers and Nonsmokers will be exposed to e-cigarette vapour (nicotine content 18 µg/ml) in this one-armed study. Vascular function measured as FMD/FMC of the brachial artery is assessed before and after 20 minuntes of standardized inhalation.

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Organizational Data

  •   DRKS00007930
  •   2015/05/05
  •   [---]*
  •   yes
  •   Approved
  •   837.412.14 (9651), Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
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Secondary IDs

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Health Condition or Problem studied

  •   healthy volunteers
  •   nicotine dependence
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Interventions/Observational Groups

  •   Non-Smokers FMD before and after inhalation (20 min)of e-cigarette vapor with nicotine (18 µg/ml)
  •   Non-Smokers FMD before and after inhalation (20 min)of e-cigarette vapor with nicotine (18 µg/ml)
  •   historic data from one time exposure to cigarette smoke
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Historical, Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   No
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Primary Outcome

Endothelial function (flow-mediated dialtion FMD % of A. brachialis) as change before and after vapor exposition measured with high resolution ultrasound before and after cuff occlusion as described in guidelines.

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Secondary Outcome

FMC (flow mediated contraction as described by Gori measured by ultrasound corresponding to FMD) measured before and after vapor exposure;
blood pressure measured with Riva-Roci and contiously before , during and after vapor exposure using pulse transit time
heart rate (ECG derived, holter monitoring before and during exposure)
sympathic nerve activity (laser Doppler before and after exposure)
sympathovagal Balance (derived from ECG heart variability measured with holter ECG during study period)
oxdiative Stress (blood)
Effect of antioxidative substances on FMD (measured as effect of p.o. VitC application on FMD after exposure)
Endothelium activation (measured in blood before and after vapor from frozen samples with the use of ELISA kits (E-selectine, VCAM etc.))
Oxidative stress (measured from frozen blood samples befor and after exposure with ELISA kits TBARS, MDA, OxLDL, MPO)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/04/01
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   60   Years
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Additional Inclusion Criteria

Non-smokers and smokers age 18-60

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Exclusion Criteria

•Smoking of tobacco products within the preceding 6 months (only cohort 1)
•Current use of long acting nitrates or calcium antagonists
•History of asthma or chronic pulmonary disease
•Vascular or other abnormalities precluding application of a pressure cuff on the arm to conduct FMD/FMC measurement
•symptomatic cardiovascular disease

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Addresses

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    • Universitätsmedizin Mainz, II. Medizinische Klinik
    • Langenbeckstr. 1
    • 55131  Mainz
    • Germany
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    • II. Medizinische Klinik
    • Mr.  Dr. med.  Frank  Schmidt 
    • Langenbeckstr. 1
    • 55131  Mainz
    • Germany
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    • Universitätsmedizin Mainz
    • Ms.  Hannelore  Seiler 
    • Langenbeckstr. 1
    • 55131  Mainz
    • Germany
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Sources of Monetary or Material Support

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    • Stiftung Mainzer Herz
    • 55131  Mainz
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/01/26
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.