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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigated group | Other | Subjects underwent procedures: hemodynamic indices will be measured at baseline and during 1/ e-cigarette without nicotine smoking, 2/ e-cigarette with nicotine and during 3/ traditional cigarette smoking in random order |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baseline | Other | measurement of baseline hemodynamic parameters |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate variability | RR intervals in ms, very low frequency (VLF), low frequency (LF), and high frequency (HF) components - ms2 | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic, diastolic, mean blood pressure | mm Hg | through study completion, an average of 1 year |
| Heart rate | beats/min | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paweł Dziliński, M.D. | Contact | 48 22 599 2828 | pawel.dzilinski@gmail.com | |
| Jacek Lewandowski, M.D., Ph.D. | Contact | 48 22 599 2828 | jlewandowski@wum.edu.pl |
| Name | Affiliation | Role |
|---|---|---|
| Jacek Lewandowski, M.D., Ph.D. | Medical University of Warsaw | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Warszawski Uniwersytet Medyczny | Recruiting | Warsaw | Masovian Voivodeship | 02-097 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42395095 | Derived | Sobieraj P, Dzilinski P, Sinski M, Kujawski S, Zalewski P, Lewandowski J. Randomized crossover trial comparing short-term hemodynamic and autonomic effects of e-cigarettes with and without nicotine and conventional cigarette smoking in apparently healthy individuals. Am J Prev Cardiol. 2026 Apr 2;28:101598. doi: 10.1016/j.ajpc.2026.101598. eCollection 2026 Aug. |
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| ID | Term |
|---|---|
| C074807 | BaseLine dental cement |
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| e-cigarette without nicotine |
| Device |
measurement hemodynamic parameters during smoking e-cigarette without nicotine |
|
| e-cigarette with nicotine | Device | measurement hemodynamic parameters smoking e-cigarette with nicotine |
|
| traditional cigarette | Device | measurement hemodynamic parameters smoking traditional cigarette |
|
| Blood pressure variability | mm Hg | through study completion, an average of 1 year |
| Puls wave velocity | m/s | through study completion, an average of 1 year |
| Stroke Volume | ml | through study completion, an average of 1 year |
| Cardiac output | ml/min | through study completion, an average of 1 year |
| Total Peripheral Resistance | dyn*sec/cm5 | through study completion, an average of 1 year |
| Baroreceptor reflex sensitivity | ms/mm Hg | through study completion, an average of 1 year |
| Muscle sympathetic nerve activity | bursts/min, bursts/100 beats/min | through study completion, an average of 1 year |