NCT03037775

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 31, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2017

Enrollment Period

2.5 years

First QC Date

January 11, 2017

Last Update Submit

January 27, 2017

Conditions

Tobacco; Use, Harmful

Keywords

tobaccocardiovascular systemsympathetic nervous system

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (9)

  • Systolic, diastolic, mean blood pressure

    through study completion, an average of 1 year

  • Heart rate

    through study completion, an average of 1 year

  • Blood pressure variability

    through study completion, an average of 1 year

  • Puls wave velocity

    through study completion, an average of 1 year

  • Stroke Volume

    through study completion, an average of 1 year

  • +4 more secondary outcomes

Study Arms (1)

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

Other: BaselineDevice: e-cigarette without nicotineDevice: e-cigarette with nicotineDevice: traditional cigarette

Interventions

BaselineOTHER

measurement of baseline hemodynamic parameters

Investigated group
e-cigarette without nicotineDEVICE

measurement hemodynamic parameters during smoking e-cigarette without nicotine

Investigated group
e-cigarette with nicotineDEVICE

measurement hemodynamic parameters smoking e-cigarette with nicotine

Investigated group
traditional cigaretteDEVICE

measurement hemodynamic parameters smoking traditional cigarette

Investigated group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Warszawski Uniwersytet Medyczny

Warsaw, Masovian Voivodeship, 02-097, Poland

RECRUITING

MeSH Terms

Interventions

BaseLine dental cementTobacco Use Cessation Devices

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Jacek Lewandowski, M.D., Ph.D.

    Medical University of Warsaw

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paweł Dziliński, M.D.

CONTACT

48 22 599 2828pawel.dzilinski@gmail.com

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

CONTACT

48 22 599 2828jlewandowski@wum.edu.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D.

Study Record Dates

First Submitted

January 11, 2017

First Posted

January 31, 2017

Study Start

June 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

January 31, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)