Study of Vascular Function Before vs After Smoking an E-cigarette as Compared to a Normal Cigarette

NCT05598125 | Terminated

• 1 other identifier: ECIG-8
• Study Type: observational
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Endothelial Function

Keywords

arterial wave reflection; microvascular function; e-cigarette

Outcome Measures

Primary Outcomes (1)

• 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

  7 days

Secondary Outcomes (8)

• Retinal arterial and venous diameter in response to flicker-light stimulation (%) as surrogate of microvascular endothelial function

  7 days

• Change in CRAE (central retinal arteriolar equivalents)

  7 days

• Change in CRVE (central retinal venular equivalents)

  7 days

• Change in AVR (arteriolar-to-venular ratio)

  7 days

• Change in circulating biomarkers of endothelial function and activation - Endothelin-1

  7 days

Study Arms (3)

Smoker_1

Begins with e-cigarette crosses over to conventional cigarette

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

Device: electronic cigarette (e-cigarette); Device: conventional tobacco cigarette

Interventions

electronic cigarette (e-cigarette) DEVICE

Smoker_1; Smoker_2

conventional tobacco cigarette DEVICE

Smoker_1; Smoker_2

Eligibility Criteria

• Age: 22 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• GWT-TUD GmbH: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Brachial artery diameter change in response to reactive hyperemia (flow-mediated vasodilation, %) * Circulating biomarkers of endothelial function and damage (endothelin-1; BH4/BH2) * Augmentation index in response to salbutamol and glyceryl trinitrate (%), * Retinal arterial and venous diameter in response to flicker-light stimulation (%) * Central retinal arterial and venous equivalent (CRAE, CRVE) and arteriolar-to-venular ratio (AVR) * Functional in vitro assays and gene expression studies (endothelial nitric oxide synthase (eNOS), NRF2 pathway and target genes (HMOX1, NQO1); adhesion molecules (ICAM1, VCAM1, SELE, CCL2))

MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

Smoking; Behavior

Study Officials

• Tjalf Ziemssen, PhD, MD

  Zentrum für Klinische Neurowissenschaften, TU-Dresden

  STUDY DIRECTOR

• Henning Morawietz, PhD

  Bereich Gefäßendothel/Mikrozirkulation, TU-Dresden

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: October 28, 2022
• Study Start: January 9, 2017
• Primary Completion: July 30, 2019
• Study Completion: July 30, 2019
• Last Updated: October 28, 2022

Record last verified: 2019-08