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The Effects of Electronic Cigarette Smoking on the Arterial Wall and Endothelial Glycocalyx Properties of Smokers

1. april 2020 opdateret af: Ignatios Ikonomidis, University of Athens
Electronic cigarette is proposed as a bridge to smoking cessation. In this study we examine its effects on aortic elasticity, glycocalyx integrity, and exhaled carbon monoxide (CO) concentration and platelet function, both acutely and after 1 month of use.

Studieoversigt

Status

Ukendt

Betingelser

Detaljeret beskrivelse

Two smoker groups matched for age and sex will be assessed:

  1. a group of 30 current smokers with no diagnosed cardiovascular disease as the control group for chronic phase
  2. a group of 30 current smokers with no diagnosed cardiovascular disease who will be using the electronic cigarette with nicotine for 1 month

In the acute phase all 60 smokers will undergo a "sham" smoking for 7 minutes. Afterwards 30 out of 60 smokers will be randomized to smoke either a normal cigarette or an electronic cigarette with nicotine and after a 60 minute washout period these subjects will be crossed over to the alternate mode of smoking (electronic with nicotine or normal cigarette respectively).

The remaining 30 smokers will be randomized to smoke either a normal cigarette or an electronic cigarette without nicotine and after a 60 minute washout period these subjects will be crossed over to the alternate mode of smoking (electronic without nicotine or normal cigarette respectively.

After the completion of the acute phase all 60 smokers will start the use of an electronic cigarette for one month.

In the acute phase, measurements will be performed at baseline, after sham smoking and after smoking of the normal or electronic cigarette (with or without nicotine). The chronic phase measurements will be performed 1 month after use electronic cigarette with nicotine. Thirty current smokers of similar age and sex will serve as controls and will have measurements at baseline and 1 month after baseline assessment. The nicotine concentration of the electronic cigarette fluid used during both phases will be 12 mg/dL, while the participants will be allowed to use their cigarette of preference in the acute phase. In both phases we will assess a) the aortic pulse wave velocity (PWV) and augmentation index (AIx) by Arteriograph and Complior; b) the perfusion boundary region of the sublingual arterial microvessels using Sideview, Darkfield imaging (Microscan, Glycocheck); c) the exhaled carbon monoxide (CO) level (parts per million -ppm) as a smoking status marker; d) the vital signs; e) an electrocardiogram; and f) plasma levels of C- reactive protein (CRP), transforming growth factor-b (TGF-b), lipoprotein associated phospholipase A2 (LP- LPA2), tumor necrosis factor- α (TNF-α), interleukins 6 and 10 (IL-6 and -10), procollagen propeptide type III (PIIINP), matrix metalloproteinase 2 and 9 (MMP-2 and -9), and macrophage-colony stimulating factor (MCSF), malondialdehyde (MDA) and protein carbonyls (PC) and platelet function tests using the novel Platelet Function Analyzer PFA-100 and the traditional Light Transmission Aggregometry (LTA)

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

90

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Attiki
      • Athens, Attiki, Grækenland, 12462
        • Rekruttering
        • ''Attikon'' University General Hospital
        • Kontakt:
          • Ignatios Ikonomidis, MD
          • Telefonnummer: 00302105831264

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 60 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Active conventional cigarette smoker

Exclusion Criteria:

  • Health condition adversely affected by smoking, history or presence of cardiovascular disease

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Electronic cigarette with or without nicotine
Electronic cigarette assisted cessation program
Smoking of electronic cigarette
Aktiv komparator: Ryger kontrol
Konventionel cigaretrygning fortsættelse
Smoking tobacco cigarette

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Acute electronic cigarette vaping effects on arterial stiffness.
Tidsramme: 7 minutes
Acute electronic cigarette vaping effects on arterial stiffness as assessed by pulse wave velocity (PWV, m/sec). PWV (m/sec) was measured by using tonometry by Complior (Alam Medical, Vincennes, France). Two non-invasive pressure sensors were used to record the carotid and femoral waveforms and the distance between the two arterial sites was measured with a tape measure.
7 minutes
Acute electronic cigarette vaping effects on endothelial integrity.
Tidsramme: 7 minutes
Acute electronic cigarette vaping effects on endothelial integrity as assessed by measuring endothelial glycocalyx thickness. We measured the perfused boundary region (PBR) of the sublingual arterial microvessels (ranged from 5 to 25 μm) using Sidestream Darkfield Imaging (Microscan, Glycocheck, Microvascular Health Solutions Inc., Salt Lake City, UT, USA).
7 minutes
Chronic electronic cigarette vaping effects on arterial stiffness.
Tidsramme: 1 month
Chronic electronic cigarette vaping effects on arterial stiffness, as assessed by pulse wave velocity (PWV, m/sec). PWV (m/sec) was measured by using tonometry by Complior (Alam Medical, Vincennes, France). Two non-invasive pressure sensors were used to record the carotid and femoral waveforms and the distance between the two arterial sites was measured with a tape measure.
1 month
Chronic electronic cigarette vaping effects on endothelial integrity.
Tidsramme: 1 month
Chronic electronic cigarette vaping effects on endothelial integrity as assessed by measuring endothelial glycocalyx thickness. We measured the perfused boundary region (PBR) of the sublingual arterial microvessels (ranged from 5 to 25 μm) using Sidestream Darkfield Imaging (Microscan, Glycocheck, Microvascular Health Solutions Inc., Salt Lake City, UT, USA).
1 month
Chronic electronic cigarette vaping effects on platelet aggregation.
Tidsramme: 1 month
Chronic electronic cigarette vaping effects on platelet function as assessed by Light Transmission Aggregometry (LTA). We measured both maximum (peak) and late platelet aggregation (%) (at 6 minutes) after addition of epinephrine (as stimulant) in platelet rich plasma.The 100% line was set using platelet poor plasma and a 0% baseline established with platelet rich plasma before addition of the agonist(epinephrine). Platelet aggregation is experssed as % of the 100% line
1 month
Chronic electronic cigarette vaping effects on high-shear stress-dependent platelet function.
Tidsramme: 1 month
Chronic electronic cigarette vaping effects on high-shear stress-dependent platelet function as assesed by PFA-100. The instrument estimates the ability of platelets activated in a high shear environment to occlude an aperture in a membrane coated with collagen and epinephrine (CEPI).The time taken for flow across the membrane to stop (closure time, CT, seconds) is recorded as measure of platelet function. Platelet adhesion and aggregation following a vascular injury is simulated in vitro by PFA.
1 month

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Ignatios Ikonomidis, Dr, Attikon Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

31. januar 2017

Primær færdiggørelse (Forventet)

1. december 2021

Studieafslutning (Forventet)

1. juni 2022

Datoer for studieregistrering

Først indsendt

28. januar 2017

Først indsendt, der opfyldte QC-kriterier

30. januar 2017

Først opslået (Skøn)

1. februar 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. april 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. april 2020

Sidst verificeret

1. april 2020

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 698/11-3-15

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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