Cardiovascular Risk FactorNCT03036644

Comparison of Electronic Cigarettes and Tobacco Cigarettes on Cardiovascular Function and Oxidative Stress

A study testing e-cigarette (PG+VG without nicotine; low temperature), e-cigarette (PG+VG with nicotine; low temperature) and e-cigarette (PG+VG without nicotine; high temperature) in people with Cardiovascular Risk Factor, run by Université Libre de Bruxelles at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Cardiovascular Risk Factor
What is being tested?: e-cigarette (PG+VG without nicotine; low temperature), e-cigarette (PG+VG with nicotine; low temperature) and e-cigarette (PG+VG without nicotine; high temperature)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 25 participants
Where: 1 siteBelgium
Study dates: 15 Jan 2017to 31 Dec 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy subjects

Who cannot join

Any form of cardiovascular disease
Any form of pulmonary disease like asthma or COPD
Any form of systemic or chronic disorder
Active allergy within 4 weeks of the study
Symptoms of infection or inflammation within 4 weeks of the study
Pregnancy

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Erasme Hospital
Brussels, Brabant, 1070

Other trials in Belgium

About this study

Official title: Effects of Electronic Cigarette Vaporization at High Temperature in Comparison to Tobacco Smoking on Cardiovascular Function and Oxidative Stress in Electronic Cigarette Users and Regular Tobacco Smokers

Background: Electronic cigarettes (e-cigarettes) are battery-powered devices heating a liquid (e-liquid) composed of propylene glycol and/or vegetable glycerin, and most commonly, nicotine to form an aerosol (vapor) that is inhaled (i.e. "vaped"). Scarce and conflicting data are available regarding the cardiovascular toxicity of e-cigarettes. We wish to determine the acute effects of propylene glycol/vegetable glycerin and nicotine vaporization at high temperature in comparison to tobacco cigarette smoking on several advanced cardiovascular parameters in healthy chronic e-cigarettes users and tobacco smokers. Furthermore, a large range of plasma, urine and respiratory oxidative stress markers will be quantified. By this way, we aim to demonstrate that e-cigarettes-induced systemic oxidative stress could be linked to cardiovascular toxicity. To the best of our knowledge, this is the first project that evaluates the effects of e-cigarettes vaping in comparison to tobacco cigarette smoking on the cardiovascular system in relation to vaporization temperature, nicotine delivery and oxidative stress.

Aims of the study: This study tests the following hypotheses: 1) acute high temperature vaporization of propylene glycol and vegetable glycerin has no deleterious effects on cardiovascular parameters in comparison to tobacco smoking; 2) Tobacco smoking rises plasma and urine oxidative stress biomarkers. On the contrary, acute and chronic e-cigarettes vaping don't rise these biomarkers. At a cellular level, plasma of smokers but not vapers increases superoxide anion production.

Conditions: Cardiovascular Risk Factor
Being tested: e-cigarette (PG+VG without nicotine; low temperature), e-cigarette (PG+VG with nicotine; low temperature), e-cigarette (PG+VG without nicotine; high temperature), e-cigarette (PG+VG with nicotine; high temperature), tobacco cigarette
Keywords: electronic cigarette, e-cigarette, oxidative stress, tobacco smoking
Medical subject headings: Vaping, Tobacco Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

e-cigarette (PG+VG without nicotine; low temperature)Device
e-cigarette (PG+VG with nicotine; low temperature)Device
e-cigarette (PG+VG without nicotine; high temperature)Device
e-cigarette (PG+VG with nicotine; high temperature)Device
tobacco cigaretteOther

Study groups in NCT03036644
Study group	Role	What they receive
e-cigarette nic_O LT	Experimental	e-cigarette (without nicotine; low temperature) Receives: Device: e-cigarette (PG+VG without nicotine; low temperature)
e-cigarette Nic_1 LT	Experimental	e-cigarette (with nicotine; low temperature) Receives: Device: e-cigarette (PG+VG with nicotine; low temperature)
e-cigarette Nic_0 HT	Experimental	e-cigarette (without nicotine; high temperature) Receives: Device: e-cigarette (PG+VG without nicotine; high temperature)
e-cigarette NIC_1 HT	Experimental	e-cigarette (with nicotine; high temperature) Receives: Device: e-cigarette (PG+VG with nicotine; high temperature)
Tobacco cigarette	Active comparator	Tobacco cigarette Receives: Other: tobacco cigarette
Placebo	Placebo comparator	No E-cigarettes, Nor tobocco cigarettes Receives: Device: e-cigarette (PG+VG without nicotine; low temperature)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in subcutaneous flux
Measured: 1 hour

Secondary outcomes (4)

Change in Plasma and urine oxidative stress markers
Measured: 1 hour
Change in aortic stiffness
Measured: 10 minutes
Change in heart rate variability
Measured: 10 minutes
Change in baroreflex sensitivity
Measured: 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jan 201731 Dec 2019

First posted30 Jan 2017 (estimated)
Study start15 Jan 2017
Primary completion31 Dec 2019
Study completion31 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Investigator
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03036644
Sponsor's protocol ID: P2017/028 / B406201630672
Status last verified: Nov 2020
First submitted: 27 Jan 2017
Last updated: 3 Nov 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Chaumont M, Bernard A, Pochet S, Melot C, El Khattabi C, Reye F, Boudjeltia KZ, Van Antwerpen P, Delporte C, van de Borne P. High-Wattage E-Cigarettes Induce Tissue Hypoxia and Lower Airway Injury: A Randomized Clinical Trial. Am J Respir Crit Care Med. 2018 Jul 1;198(1):123-126. doi: 10.1164/rccm.201711-2198LE. No abstract available.
PubMed 29451806

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cardiovascular Risk Factor trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Electronic Cigarette Vaporization at High Temperature in Comparison to Tobacco Smoking on Cardiovascular Function and Oxidative Stress in Electronic Cigarette Users and Regular Tobacco Smokers
ClinicalTrials.gov ID: NCT03036644
Acronym / sponsor ID: P2017/028 / B406201630672
Conditions: Cardiovascular Risk Factor
Keywords: electronic cigarette, e-cigarette, oxidative stress, tobacco smoking
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Université Libre de BruxellesUniversity, hospital or other
Study start: 15 Jan 2017 (actual)
Primary completion: 31 Dec 2019 (actual)
Study completion: 31 Dec 2019 (actual)
First posted: 30 Jan 2017 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (investigator)
Number of arms: 6

Arm	Type	Receives
e-cigarette nic_O LT	Experimental	Device: e-cigarette (PG+VG without nicotine; low temperature)e-cigarette (without nicotine; low temperature)
e-cigarette Nic_1 LT	Experimental	Device: e-cigarette (PG+VG with nicotine; low temperature)e-cigarette (with nicotine; low temperature)
e-cigarette Nic_0 HT	Experimental	Device: e-cigarette (PG+VG without nicotine; high temperature)e-cigarette (without nicotine; high temperature)
e-cigarette NIC_1 HT	Experimental	Device: e-cigarette (PG+VG with nicotine; high temperature)e-cigarette (with nicotine; high temperature)
Tobacco cigarette	Active comparator	Other: tobacco cigaretteTobacco cigarette
Placebo	Placebo comparator	Device: e-cigarette (PG+VG without nicotine; low temperature)No E-cigarettes, Nor tobocco cigarettes

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Healthy subjects

Key exclusion criteria (6 listed)

Any form of cardiovascular disease
Any form of pulmonary disease like asthma or COPD
Any form of systemic or chronic disorder
Active allergy within 4 weeks of the study
Symptoms of infection or inflammation within 4 weeks of the study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
e-cigarette (PG+VG without nicotine; low temperature)	Device	Placebo, e-cigarette nic_O LT
e-cigarette (PG+VG with nicotine; low temperature)	Device	e-cigarette Nic_1 LT
e-cigarette (PG+VG without nicotine; high temperature)	Device	e-cigarette Nic_0 HT
e-cigarette (PG+VG with nicotine; high temperature)	Device	e-cigarette NIC_1 HT
tobacco cigarette	Other	Tobacco cigarette

Primary outcome

Change in subcutaneous flux
Time frame: 1 hour

4 secondary outcomes

Change in Plasma and urine oxidative stress markers
Time frame: 1 hour
Change in aortic stiffness
Time frame: 10 minutes
Change in heart rate variability
Time frame: 10 minutes
Change in baroreflex sensitivity
Time frame: 10 minutes

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
Derived from this study: PubMed 29451806Chaumont M, Bernard A, Pochet S, Melot C, El Khattabi C, Reye F, Boudjeltia KZ, Van Antwerpen P, Delporte C, van de Borne P. High-Wattage E-Cigarettes Induce Tissue Hypoxia and Lower Airway Injury: A Randomized Clinical Trial. Am J Respir Crit Care Med. 2018 Jul 1;198(1):123-126. doi: 10.1164/rccm.201711-2198LE. No abstract available.
Individual participant dataSharing planned: No

Related trials for Cardiovascular Risk Factor

Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Not yet recruiting
Multimodal AI-Driven Out-of-Hospital Management for Hypertension and Cardiometabolic Risk
Hypertension, Hyperglycemia
Recruiting
Determining Efficacy of an Artificial Intelligence-based System for Heart Failure Detection Through Interpretation of Electrocardiograms (DECISION)
Heart Failure, Cardiovascular Risk Factors

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jean-Paul Van Vooren study director

Hospital Erasme

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in subcutaneous flux (time frame: 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03036644, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.