Diesel Exhaust Inhalation, Systemic Nitric Oxide Inhibition and Cardiac Output (DISCO)
15. december 2011 opdateret af: University of Edinburgh
Exposure to combustion-derived fine particulate air pollution is associated with cardiovascular mortality and morbidity.
In previous studies, exposure to diesel exhaust (a major constituent of urban particulate air pollution) has been shown to impair two important functions of the vascular endothelium: vascular vasomotor function and endogenous fibrinolysis.
Our subsequent studies suggest this impairment of vascular function is mediated by a reduction in nitric oxide bioavailability.
In this study we aim to investigate the cardiovascular responses to systemic nitric oxide synthase inhibition following exposure to dilute diesel exhaust.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
14
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Umeå, Sverige
- University Hospital Umeå
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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 og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Healthy volunteers
- Non smokers
- No regular medication (except oral contraceptive)
- No recent respiratory tract infection (within 6 weeks)
Exclusion Criteria:
- History of asthma or respiratory disease
- Smoking history
- Pregnancy (positive urinary pregnancy test)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Diesel exhaust exposure
1 hour exposure to dilute diesel exhaust ~ 300 mcg/m3 - during intermittent exercise
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Intravenous infusion of 3mg/kg L-NMMA (L-NG-monomethyl arginine; NO synthase inhibitor) and nor-epinephrine at 50 ng/kg/min.
Each infusion to run over 15 mins and separated by 45 min to allow return to baseline.
Drugs infused in a randomised order.
During the study, blood pressure will be measured invasively using an intra-arterial radial artery cannula, central arterial stiffness measured using peripheral arterial tonometry and cardiac output using thoracic bioimpedance.
Andre navne:
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Eksperimentel: Air exposure
1 hour exposure to filtered air during intermittent exercise
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Intravenous infusion of 3mg/kg L-NMMA (L-NG-monomethyl arginine; NO synthase inhibitor) and nor-epinephrine at 50 ng/kg/min.
Each infusion to run over 15 mins and separated by 45 min to allow return to baseline.
Drugs infused in a randomised order.
During the study, blood pressure will be measured invasively using an intra-arterial radial artery cannula, central arterial stiffness measured using peripheral arterial tonometry and cardiac output using thoracic bioimpedance.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Blood pressure response to NO inhibition
Tidsramme: Blood pressure will be measured continuously through the vascular study using intra-arterial monitoring
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Blood pressure will be measured continuously through the vascular study using intra-arterial monitoring
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Heart rate response to systemic nitric oxide inhibition
Tidsramme: Heart rate will be measured continuously throughout the study period using continous electrocardiography
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Heart rate will be measured continuously throughout the study period using continous electrocardiography
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Central arterial stiffness following NO inhibition
Tidsramme: Measured at baseline, and every 5 minutes during the 2-hour vascular study
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Measured at baseline, and every 5 minutes during the 2-hour vascular study
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Cardiac output during NO inhibition
Tidsramme: Measured at baseline, and every 5 minutes during the 2-hour vascular study
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Measured at baseline, and every 5 minutes during the 2-hour vascular study
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Plasma nitrite (NO) concentrations
Tidsramme: Measured at baseline, and every 15 minutes during the 2-hour vascular study
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Measured at baseline, and every 15 minutes during the 2-hour vascular study
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Platelet activation and platelet-monocyte binding
Tidsramme: Measured at baseline, and every 30 minutes during the 2-hour vascular study
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Measured at baseline, and every 30 minutes during the 2-hour vascular study
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Heart rate variability
Tidsramme: Heart rate will be measured continuously throughout the study period using continous electrocardiography, and HRV subsequently determined for the whole study period and the 2-hour vascular study separately
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Heart rate will be measured continuously throughout the study period using continous electrocardiography, and HRV subsequently determined for the whole study period and the 2-hour vascular study separately
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Jeremy P Langrish, MB BCh MRCP, University of Edinburgh
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
1. marts 2010
Primær færdiggørelse (Faktiske)
1. juni 2010
Studieafslutning (Faktiske)
1. juni 2010
Datoer for studieregistrering
Først indsendt
28. januar 2010
Først indsendt, der opfyldte QC-kriterier
1. februar 2010
Først opslået (Skøn)
2. februar 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
16. december 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. december 2011
Sidst verificeret
1. april 2011
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Luftvejssygdomme
- Respirationsforstyrrelser
- Respiratorisk aspiration
- Lægemidlers fysiologiske virkninger
- Adrenerge midler
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Autonome agenter
- Agenter fra det perifere nervesystem
- Enzymhæmmere
- Adrenerge alfa-agonister
- Adrenerge agonister
- Bronkodilatatorer
- Anti-astmatiske midler
- Respiratoriske midler
- Adrenerge beta-agonister
- Sympatomimetika
- Vasokonstriktormidler
- Mydriatics
- Noradrenalin
- Adrenalin
- omega-N-methylarginin
Andre undersøgelses-id-numre
- DISCO
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .