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The Influence of Electronic and Traditional Cigarettes Smoking on Hemodynamic Parameters

NCT ID: NCT03037775

Last Updated: 2017-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Tobacco; Use, Harmful

Keywords

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tobacco cardiovascular system sympathetic nervous system

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Investigated group

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

Group Type OTHER

Baseline

Intervention Type OTHER

measurement of baseline hemodynamic parameters

e-cigarette without nicotine

Intervention Type DEVICE

measurement hemodynamic parameters during smoking e-cigarette without nicotine

e-cigarette with nicotine

Intervention Type DEVICE

measurement hemodynamic parameters smoking e-cigarette with nicotine

traditional cigarette

Intervention Type DEVICE

measurement hemodynamic parameters smoking traditional cigarette

Interventions

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Baseline

measurement of baseline hemodynamic parameters

Intervention Type OTHER

e-cigarette without nicotine

measurement hemodynamic parameters during smoking e-cigarette without nicotine

Intervention Type DEVICE

e-cigarette with nicotine

measurement hemodynamic parameters smoking e-cigarette with nicotine

Intervention Type DEVICE

traditional cigarette

measurement hemodynamic parameters smoking traditional cigarette

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* healthy volunteers aged 18 - 60 years
* 12-hour abstinence from tobacco smoke, alcohol or coffee before the experiment will be required

Exclusion Criteria

* 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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Warsaw

OTHER

Sponsor Role lead

Responsible Party

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Jacek Lewandowski

M.D., Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jacek Lewandowski, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Warsaw

Locations

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Warszawski Uniwersytet Medyczny

Warsaw, Masovian Voivodeship, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Paweł Dziliński, M.D.

Role: CONTACT

Phone: 48 22 599 2828

Email: [email protected]

Jacek Lewandowski, M.D., Ph.D.

Role: CONTACT

Phone: 48 22 599 2828

Email: [email protected]

Facility Contacts

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Jacek Lewandowski, M.D., Ph.D.

Role: primary

Paweł Dziliński, M.D.

Role: backup

Other Identifiers

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EPAPHemo

Identifier Type: -

Identifier Source: org_study_id