Endothelial FunctionECIG-8NCT05598125
Study of Vascular Function Before vs After Smoking an E-cigarette as Compared to a Normal Cigarette
An observational study of Endothelial Function, run by GWT-TUD GmbH.
Trial summary
Investigation of the effect of one-time use of an electronic e-cigarette in comparison to smoking a conventional cigarette on in vivo conduit endothelial function in healthy long-term smokers Read more about this study
- Who is it for?
- Ages 22 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Endothelial Function
- What is being tested?
- electronic cigarette (e-cigarette) and conventional tobacco cigarette
- Type of treatment
- Medical device
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 9 Jan 2017to 30 Jul 2019
- Phase
- Observational
- 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 22 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: 80 smokers 25 never smokers will be additionally recruited as a control group who will undergo the same measurements and analyses without smoking intervention.
Who may be able to join
- • Subjects must be males between 22 and 35 years of age, inclusive.
- Subjects must be able to comprehend, sign and date a written informed consent prior to entering the study.
- Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
- Subjects must have experienced one of the following:
- Smoked for at least the last 4 years and at least 5 cigarettes a day or 1 pack-years,
- Never having regularly smoked, i.e. < 20 cigarettes in their lifetime and not in last 5 years.
Who cannot join
- Consumption of cigars, other tobacco and nicotine products and light-cigarettes (less than 8 mg ISO tar).
- Exhaled CO levels < 10 ppm (smokers) and ≥ 10 ppm (never smokers).
- Urinary cotinine < 200 ng/ml for smoker group
- Treatment for arterial hypertension, or clinic blood pressure ≥140/90 mmHg.
- Body mass index ≥ 30 kg/m2
- Ocular diseases, glaucoma.
Show all 13Show fewer
- Convulsive disorder/epilepsy or intake of anticonvulsant drugs.
- Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation, as determined by medical history, physical exams, ECG, abnormal laboratory tests. Such conditions may include hepatic, renal or metabolic diseases, systemic disease, acute infection, current malignancy or recent history (5 years) of malignancy, major psychiatric disorder, history of drug and/or alcohol abuse and allergies that could be detrimental according to the investigator's judgment.
- Prior participation in a clinical study in last 4 weeks.
- Intake of drugs with potential impact on the endothelial function resp. autonomic nervous system.
- Known intolerance against salbutamol, nitroglycerin and/or propylene glycol.
- Regular intake of vitamins and mineral supplements.
- Heavy exercisers and trained athletes (> 5 hours physical activity / week).
About this study
Official title: Comparative Investigation of the One-time Use of an Electronic Cigarette (E-cigarette) Versus a Normal Tobacco Cigarette on Vascular Function in Healthy Male Smokers
Investigation of the effect of one-time use of an electronic e-cigarette in comparison to smoking a conventional cigarette on in vivo conduit endothelial function in healthy long-term smokers
Read the detailed description
The overall aim of this study is to compare the short-term vascular effects of smoking an e-cigarette versus smoking a conventional tobacco cigarette in vivo and in vitro.
The specific objectives are as follows:
- To evaluate the effects of e-cigarette and conventional combustible cigarette (CCC) use on microvascular and macrovascular endothelial function and stiffness in healthy smokers. ii. To assess circulating markers of endothelial function in response to e-cigarette and CCC smoking. iii. To investigate the vascular effects of e-cigarette and CCC use on a molecular level by exposing endothelial cells with stimulated serum from the intervention study.
Primary Objective and Outcome Parameter:
The primary objective of this investigator initiated trial (IIT) is to evaluate the short-term effect of e-cigarette puffing on conduit artery function in comparison to smoking a CCC in healthy male long-term smokers.
The relative change in brachial artery diameter in response to reactive hyperemia (flow-mediated vasodilation), a validated surrogate marker of conduit endothelial function, will be used as primary endpoint. FMD [%] is defined as (brachial diameter 60 s after cuff deflation [mm] - baseline brachial diameter [mm]) x 100 / baseline brachial diameter [mm].
The primary outcome measure is the absolute difference of FMD after e-cigarette and CCC.
Secondary Objective and Outcome Parameter:
The secondary objectives are to evaluate in vivo endothelial function in other vascular beds, especially in the microcirculation and the systemic circulation, as well as other aspects of vascular function like stiffness of the arterial tree. Endothelial dysfunction, a key event of atherosclerosis development, is characterized by a respective increase or decrease of endothelium-derived molecules and changes in upstream signaling pathways that control the synthesis and bioavailability of these endothelium-derived molecules. Analysis of circulating biomarkers of endothelial function and expression studies of enzymes involved in endothelial activation will help to closely characterize possible effects of e-cigarette exposure on in vivo endothelial function.
Secondary endpoints are:
- Augmentation index in response to salbutamol (%) as surrogate of global endothelial function in relation to its response to glyceryl trinitrate (%)
- Augmentation index (%) as marker of pulse wave reflection and stiffness
- Retinal arterial and venous diameter in response to flicker-light stimulation (%) as surrogate of microvascular endothelial function
- Central retinal arterial and venous equivalent and arteriolar-to-venular ratio as indicators of generalized arterial narrowing
- Circulating biomarkers of endothelial function and activation (Endothelin-1; BH4/BH2) Secondary outcome measures are the absolute differences of secondary endpoints between e-cigarette and CCC (refer to section 13.4.2).
Functional in vitro assays and molecular analyses:
- mRNA and protein expression of endothelial nitric oxide synthase (eNOS), NRF2 target genes HMOX1, NQO1 and adhesion molecules (ICAM1, VCAM1, SELE, CCL2).
- Primary cultures of human umbilical vein endothelial cells will be stimulated with serum of human subjects (sampled before or after smoking of one cigarette or e-cigarette) and potential of wound healing will be determined.
Tertiary Objective and Outcome Parameter:
The tertiary objective is to assess differences in vascular function between smokers and never smokers. Tertiary endpoints are baseline values of primary and secondary endpoints.
- Conditions
- Endothelial Function
- Being tested
- electronic cigarette (e-cigarette), conventional tobacco cigarette
- Keywords
- arterial wave reflection, microvascular function, e-cigarette
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electronic cigarette (e-cigarette)Device
conventional tobacco cigaretteDevice
| Study group | Role | What they receive |
|---|---|---|
| Smoker_1 | Begins with e-cigarette crosses over to conventional cigarette Receives: Device: electronic cigarette (e-cigarette); Device: conventional tobacco cigarette | |
| Non smoker | never smoking participants as control group | |
| Smoker_2 | Begins with conventional cigarette crosses over to e-cigarette Receives: Device: electronic cigarette (e-cigarette); Device: conventional tobacco cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in conduit artery function related to the smoking pattern
Conduit artery function is defined as the relative response of brachial artery diameter to reactive hyperemia termed as flow-mediated vasodilation (FMD). The primary outcome measure is the absolute difference of FMD after e-cigarette and conventional cigarette consume
Measured: 7 days
Secondary outcomes (8)
Retinal arterial and venous diameter in response to flicker-light stimulation (%) as surrogate of microvascular endothelial function
Secondary outcome measures are the absolute differences of secondary endpoints between e-cigarette and CCC
Measured: 7 days
Change in CRAE (central retinal arteriolar equivalents)
To assess circulating marker of endothelial function in response to e-cigarette and CCC smoking.
Central retinal arteriolar as marker of retinal structural microvascular abnormalities esp. generalized arteriolar narrowing and venular widening CRAE [µm]: will be automatically determined
Measured: 7 days
Change in CRVE (central retinal venular equivalents)
To assess circulating marker of endothelial function in response to e-cigarette and CCC smoking.
Central retinal venular equivalents as marker of retinal structural microvascular abnormalities esp. generalized arteriolar narrowing and venular widening CRVE [µm]: will be automatically determined
Measured: 7 days
Change in AVR (arteriolar-to-venular ratio)
To assess circulating marker of endothelial function in response to e-cigarette and CCC smoking.
Arteriolar-to-venular ratio as marker of retinal structural microvascular abnormalities esp. generalized arteriolar narrowing and venular widening AVR: will be automatically determined
Measured: 7 days
Change in circulating biomarkers of endothelial function and activation - Endothelin-1
To assess circulating marker of endothelial function in response to e-cigarette and CCC smoking.
Endothelin-1 [pg/ml]
Measured: 7 days
Change in circulating biomarkers of endothelial function and activation - BH4/BH2
To assess circulating marker of endothelial function in response to e-cigarette and CCC smoking.
BH4/BH2
Measured: 7 days
Augmentation index in response to salbutamol (%) as surrogate of global endothelial function in relation to its response to glyceryl trinitrate (%)
Secondary outcome measures are the absolute differences of secondary endpoints between e-cigarette and CCC
Measured: 7 days
Augmentation index (%) as marker of pulse wave reflection and stiffness
Secondary outcome measures are the absolute differences of secondary endpoints between e-cigarette and CCC
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start9 Jan 2017
- Primary completion30 Jul 2019
- Study completion30 Jul 2019
Why it stopped: due to recruitment reasons the study was prematurely ended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial FunctionStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- GWT-TUD GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tjalf Ziemssen, PhD, MD, Study director, Zentrum für Klinische Neurowissenschaften, TU-DresdenHenning Morawietz, PhD, Study director, Bereich Gefäßendothel/Mikrozirkulation, TU-Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05598125
- Sponsor's protocol ID
- ECIG-8
- Acronym
- ECIG-8
- Status last verified
- Aug 2019
- First submitted
- 1 Aug 2019
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Investigation of the One-time Use of an Electronic Cigarette (E-cigarette) Versus a Normal Tobacco Cigarette on Vascular Function in Healthy Male Smokers
- ClinicalTrials.gov ID
- NCT05598125
- Acronym / sponsor ID
- ECIG-8 / ECIG-8
- Conditions
- Endothelial Function
- Keywords
- arterial wave reflection, microvascular function, e-cigarette
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: due to recruitment reasons the study was prematurely ended
- Enrolment
- 64 participants (actual)
- Lead sponsor
- GWT-TUD GmbHUniversity, hospital or other
- Study start
- 9 Jan 2017 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 28 Oct 2022 (actual)
- 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.
Investigation of the effect of one-time use of an electronic e-cigarette in comparison to smoking a conventional cigarette on in vivo conduit endothelial function in healthy long-term smokers
Detailed description
The overall aim of this study is to compare the short-term vascular effects of smoking an e-cigarette versus smoking a conventional tobacco cigarette in vivo and in vitro.
The specific objectives are as follows:
- To evaluate the effects of e-cigarette and conventional combustible cigarette (CCC) use on microvascular and macrovascular endothelial function and stiffness in healthy smokers. ii. To assess circulating markers of endothelial function in response to e-cigarette and CCC smoking. iii. To investigate the vascular effects of e-cigarette and CCC use on a molecular level by exposing endothelial cells with stimulated serum from the intervention study.
Primary Objective and Outcome Parameter:
The primary objective of this investigator initiated trial (IIT) is to evaluate the short-term effect of e-cigarette puffing on conduit artery function in comparison to smoking a CCC in healthy male long-term smokers.
The relative change in brachial artery diameter in response to reactive hyperemia (flow-mediated vasodilation), a validated surrogate marker of conduit endothelial function, will be used as primary endpoint. FMD [%] is defined as (brachial diameter 60 s after cuff deflation [mm] - baseline brachial diameter [mm]) x 100 / baseline brachial diameter [mm].
The primary outcome measure is the absolute difference of FMD after e-cigarette and CCC.
Secondary Objective and Outcome Parameter:
The secondary objectives are to evaluate in vivo endothelial function in other vascular beds, especially in the microcirculation and the systemic circulation, as well as other aspects of vascular function like stiffness of the arterial tree. Endothelial dysfunction, a key event of atherosclerosis development, is characterized by a respective increase or decrease of endothelium-derived molecules and changes in upstream signaling pathways that control the synthesis and bioavailability of these endothelium-derived molecules. Analysis of circulating biomarkers of endothelial function and expression studies of enzymes involved in endothelial activation will help to closely characterize possible effects of e-cigarette exposure on in vivo endothelial function.
Secondary endpoints are:
- Augmentation index in response to salbutamol (%) as surrogate of global endothelial function in relation to its response to glyceryl trinitrate (%)
- Augmentation index (%) as marker of pulse wave reflection and stiffness
- Retinal arterial and venous diameter in response to flicker-light stimulation (%) as surrogate of microvascular endothelial function
- Central retinal arterial and venous equivalent and arteriolar-to-venular ratio as indicators of generalized arterial narrowing
- Circulating biomarkers of endothelial function and activation (Endothelin-1; BH4/BH2) Secondary outcome measures are the absolute differences of secondary endpoints between e-cigarette and CCC (refer to section 13.4.2).
Functional in vitro assays and molecular analyses:
- mRNA and protein expression of endothelial nitric oxide synthase (eNOS), NRF2 target genes HMOX1, NQO1 and adhesion molecules (ICAM1, VCAM1, SELE, CCL2).
- Primary cultures of human umbilical vein endothelial cells will be stimulated with serum of human subjects (sampled before or after smoking of one cigarette or e-cigarette) and potential of wound healing will be determined.
Tertiary Objective and Outcome Parameter:
The tertiary objective is to assess differences in vascular function between smokers and never smokers. Tertiary endpoints are baseline values of primary and secondary endpoints.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Smoker_1 | – | Device: electronic cigarette (e-cigarette), Device: conventional tobacco cigaretteBegins with e-cigarette crosses over to conventional cigarette |
| Non smoker | – | –never smoking participants as control group |
| Smoker_2 | – | Device: electronic cigarette (e-cigarette), Device: conventional tobacco cigaretteBegins with conventional cigarette crosses over to e-cigarette |
Who may qualify
- Ages
- 22 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 80 smokers 25 never smokers will be additionally recruited as a control group who will undergo the same measurements and analyses without smoking intervention.
Key inclusion criteria (6 listed)
- • Subjects must be males between 22 and 35 years of age, inclusive.
Key exclusion criteria (13 listed)
- Consumption of cigars, other tobacco and nicotine products and light-cigarettes (less than 8 mg ISO tar).
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 |
|---|---|---|
| electronic cigarette (e-cigarette) | Device | Smoker_1, Smoker_2 |
| conventional tobacco cigarette | Device | Smoker_1, Smoker_2 |
Primary outcome
change in conduit artery function related to the smoking pattern
Time frame: 7 days
Conduit artery function is defined as the relative response of brachial artery diameter to reactive hyperemia termed as flow-mediated vasodilation (FMD). The primary outcome measure is the absolute difference of FMD after e-cigarette and conventional cigarette consume
8 secondary outcomes
Retinal arterial and venous diameter in response to flicker-light stimulation (%) as surrogate of microvascular endothelial function
Time frame: 7 days
Change in CRAE (central retinal arteriolar equivalents)
Time frame: 7 days
Change in CRVE (central retinal venular equivalents)
Time frame: 7 days
Change in AVR (arteriolar-to-venular ratio)
Time frame: 7 days
Change in circulating biomarkers of endothelial function and activation - Endothelin-1
Time frame: 7 days
Change in circulating biomarkers of endothelial function and activation - BH4/BH2
Time frame: 7 days
Augmentation index in response to salbutamol (%) as surrogate of global endothelial function in relation to its response to glyceryl trinitrate (%)
Time frame: 7 days
Augmentation index (%) as marker of pulse wave reflection and stiffness
Time frame: 7 days
Results and safety
The study was stopped early (reason given: due to recruitment reasons the study was prematurely ended). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
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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.
Tjalf Ziemssen, PhD, MD study director
Zentrum für Klinische Neurowissenschaften, TU-Dresden
Henning Morawietz, PhD study director
Bereich Gefäßendothel/Mikrozirkulation, TU-Dresden
Questions about this trial
What is this clinical trial studying?
An observational study of Endothelial Function, run by GWT-TUD GmbH.
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 6 inclusion and 13 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: stopped early, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 was stopped early (reason given: due to recruitment reasons the study was prematurely ended). Results are not available in the source record.
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 conduit artery function related to the smoking pattern (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2022.