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Impact of Ban on Smoking in Pubs, Restaurants and Nightclubs on Endothelial Function in Workers (DILATER)

14. april 2017 oppdatert av: University Hospital, Toulouse

Impact of Ban on Smoking in Pubs, Restaurants and Nightclubs on Endothelial Function in Workers : Evaluation of Endothelial Vasomotoricity Before and After Cessation of Exposure to Passive Smoking : DILATER Study

Endothelium is considered a real member, so it is contributing to determine the vascular homeostasis. The presence of endothelial dysfunction, evaluated in peripheral arteries by non-invasive study of the variation of gauge of the brachial artery as a result of post-ischemic hyperemia (FMD), is predictive of occurrence of major cardiovascular events. Several recent studies have shown that passive smoking is correlated with endothelial dysfunction and, therefore, non-smokers exposed subjects to passive smoking, have an increased risk of occurrence cardiovascular pathologies. From January 2008, a ministerial decree will ban smoking in bars, restaurants and nightclubs. The impact of exposure end to smoking in non-smoking subjects, as part of a prospective study and controlled, has never been evaluated.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

49

Fase

  • Ikke aktuelt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Subject exposed at least one hour per day to passive smoking at work during at 1 year minimum for intervention arm and non exposed to passive smoking for control group.
  • Subject having signed informed consent
  • Subject with social security insurance or equivalent

Exclusion Criteria:

  • Exposition to passive smoking at home
  • Active smokers (at least 1 cigarette per day or having drawn up active smoking for less than a month)
  • Medical history of homozygote familial hypercholesterolemia
  • Usage of lipid lowering treatment in the month before the inclusion
  • Hepatic active pathology or hepatocellular insufficiency
  • Severe kidney disease (with creatine clearance less than 30 ml per minute)
  • Evolutive cancer
  • Usage of concomitant treatment as : insulin, nitro-derivatives and statins
  • Medical history of alcoholism or drug use last year
  • Medical history of permanent systolic hypotension (systolic blood pressure less than 90 mmHg) or non controled hypertension (systolic blood pressure higher than 200 mmHg and diastolic blood pressure 110 mmHg)
  • Active cardiovascular disease
  • Psychological or medical conditions incompatible with the study according to investigator opinion
  • Participation to another study with experimental product or subject having received an study treatment within 4 weeks before inclusion
  • Impossibility to follow the study procedure
  • Pregnancy and breastfeeding
  • Subject protected by french law

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Intervention

Subjects exposed to passive smoking at least 1 hour per day since 1 year, non active smokers, non exposed to passive smoking at home

Subject will receive a complete medical follow-up including : medical examination, medical interrogatory, general bioassay, specific bioassay and endothelial function evaluation
Annen: Medical interrogatory
Cardiovascular risk, medical history, known pathologies and actual treatments are evaluated
Annen: Medical examination
Systolic blood pressure, diastolic blood pressure, cardiac frequency, pulse palpation, hearth and pulmonary auscultation
Annen: Specific bioassay
Exhaled carbon monoxide measure and nicotine in the urine are evaluated
Annen: Endothelial function evaluation
Endothelial function evaluation done by echotracking determining the basale flow mediated dilatation
Annen: General bioassay
Fasting bioassay evaluating total cholesterol, low density lipoproteins, high density lipoproteins, triglycerides, creatine, transaminases, gamma glutamyl transferases, fibrinogen, reactive protein C, blood count and sedimentation rate.
Annen: Control

Subjects non expose to passive smoking at home or at work, non active smokers

Subject will receive a complete medical follow-up including : medical examination, medical interrogatory, general bioassay, specific bioassay and endothelial function evaluation
Annen: Medical interrogatory
Cardiovascular risk, medical history, known pathologies and actual treatments are evaluated
Annen: Medical examination
Systolic blood pressure, diastolic blood pressure, cardiac frequency, pulse palpation, hearth and pulmonary auscultation
Annen: Specific bioassay
Exhaled carbon monoxide measure and nicotine in the urine are evaluated
Annen: Endothelial function evaluation
Endothelial function evaluation done by echotracking determining the basale flow mediated dilatation
Annen: General bioassay
Fasting bioassay evaluating total cholesterol, low density lipoproteins, high density lipoproteins, triglycerides, creatine, transaminases, gamma glutamyl transferases, fibrinogen, reactive protein C, blood count and sedimentation rate.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Comparison of Endothelial function between two groups of non smoking workers exposed or not to passive smoking at work before and after interdiction of smoking decree as assessed by mean change in dilatation percentage of brachial artery.
Tidsramme: change between Day 0 and Day 90
Percentage of dilation of the brachial artery after test ischemia will be compared at the start and at the end of the study (Day 90)
change between Day 0 and Day 90

Sekundære resultatmål

Resultatmål
Tidsramme
Determination of flow mediated dilatation in non smokers patient as assessed by mean change in dilatation percentage of brachial artery.
Tidsramme: change between Day 0 and Day 90
change between Day 0 and Day 90

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University Hospital, Toulouse

Etterforskere

  • Hovedetterforsker: Alessandra BURA-RIVIERE, MD, University Hospital, Toulouse

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. desember 2007

Primær fullføring (Faktiske)

1. juni 2008

Studiet fullført (Faktiske)

1. juni 2008

Datoer for studieregistrering

Først innsendt

9. mars 2016

Først innsendt som oppfylte QC-kriteriene

17. mai 2016

Først lagt ut (Anslag)

20. mai 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. april 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. april 2017

Sist bekreftet

1. april 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 07 269 03

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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