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Clinical Trial Summary

It is intended to examine 50 healthy volunteers aged 18 - 60 years. 12-hour abstinence from tobacco smoke, alcohol or coffee before the experiment will be required. The exclusion criteria are medical history of stroke, coronary artery disease, chronic heart failure, hypertension, peripheral vascular disease, atrial fibrillation, polyneuropathy, obesity (BMI> 30 kg/m2), the current active disease (eg. viral infection). Test subjects will actively inhale for 10 minutes tobacco or the e-cigarette smoke with nicotine fluid (18 mg/ml) or fluid without nicotine for 10 minutes. The study protocol involves random allocation to groups exposed to electronic or traditional cigarette smoke in cross-over scheme. The primary endpoint is the maximum change in heart rate compared to mean values prior to exposure. Secondary end points is the maximum change in the measured parameters (hemodynamic and autonomic values) compared to the average values before exposure. The measurements will be performed using the Task Force Monitor system for non-invasive measurement of hemodynamic parameters and the assessment of autonomic function. Adrenergic activity will be tested with microneurography. A periodic analysis is planned after examining 15 and 35 patients.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03037775
Study type Interventional
Source Medical University of Warsaw
Contact Pawel Dzilinski, M.D.
Phone 48 22 599 2828
Email pawel.dzilinski@gmail.com
Status Recruiting
Phase N/A
Start date June 2015
Completion date December 2017

See also
  Status Clinical Trial Phase
Completed NCT04776863 - Effect of Smokeless Tobacco on Anterior Segment