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Cardiovascular Effects of Exposure to Ozone (MOSES)

8. juni 2012 oppdatert av: Health Effects Institute

Multicenter Ozone Study in Elderly Subjects

The Multicenter Ozone Study in Elderly Subjects will investigate whether short-term exposure of elderly volunteers to ambient levels of ozone in a controlled exposure setting causes acute cardiovascular responses as assessed by changes in blood pressure, cardiac function, and systemic biomarkers of inflammation, endothelial dysfunction, and thrombosis.

Studieoversikt

Status

Ukjent

Forhold

Detaljert beskrivelse

This multicenter study will investigate whether short-term exposure of elderly volunteers to ambient levels of O3 in a controlled exposure setting while intermittently exercising causes acute cardiovascular responses. The study is based on the suppositions that: 1) elderly people are a susceptible group for cardiovascular effects; and 2) effects are more likely with exercise.

The study will involve approximately 90 healthy volunteers aged ≥55 and ≤70 who meet strict criteria for inclusion. They will be exposed for 3 hours to clean air, 0.07 ppm O3 (near the current NAAQS), and 0.12 ppm O3 (a level measured in several locations in the US). A suite of cardiovascular and pulmonary endpoints will be measured on the day before the exposure and up to 22 hours after the exposures. The study is being conducted at three centers using a common protocol and common SOPs. Most the endpoints will be analyzed by core laboratories to reduce the variability in the results. A Data Coordination and Analysis Center will assemble all the data generated by the three centers and conduct the statistical analyses on the combined data sets.

The study has 3 main objectives:

  1. To determine the relationship of altered autonomic balance (measured as changes in heart rate and heart rate variability (HRV)), cardiac arrhythmia, and repolarization and ozone exposure.
  2. To identify instances of altered systemic vascular function [measured as brachial artery flow-mediated dilation (FMD)without and with nitroglycerin (NTG) when exposed to ozone.
  3. To identify pro-thrombotic vascular state (measured as increase in von Willebrand factor antigen in blood - primary endpoints) when exposed to ozone.

Additional objectives include:

  1. To identify any increase in micro particle-associated tissues factor (measured as number of particles and tissue factor activity) and platelet activation) in ozone exposure.
  2. To identify if markers of systemic oxidative stress and inflammation and any correlation with the cardiovascular effects and degree of airway injury (measured as CC16) and airway inflammatory effects (neutrophils and cytokines in induced sputum) in ozone exposure.
  3. To determine if cardiovascular effects in ozone exposure are correlated with airway inflammatory effects, but not lung function effects.

Studietype

Observasjonsmessig

Registrering (Forventet)

90

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • California
      • San Francisco, California, Forente stater, 94143
        • Rekruttering
        • University of California at San Francisco
        • Ta kontakt med:
        • Hovedetterforsker:
          • John Balmes, MD
    • Massachusetts
      • Watertown, Massachusetts, Forente stater, 02472
        • Aktiv, ikke rekrutterende
        • New England Research Institutes, Inc.
    • New York
      • Rochester, New York, Forente stater, 14642
        • Rekruttering
        • University of Rochester
        • Ta kontakt med:
        • Hovedetterforsker:
          • Mark Frampton, MD
    • North Carolina
      • Chapel Hill, North Carolina, Forente stater, 27599
        • Rekruttering
        • University of North Carolina At Chapel Hill
        • Ta kontakt med:
        • Hovedetterforsker:
          • Philip Bromberg, MD

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

55 år til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Healthy elderly volunteers living in or around San Francisco, CA, Research Triangle Park, NC, and Rochester, NY

Beskrivelse

Inclusion Criteria:

  • males and females of all ethnic backgrounds.
  • Normal spirometry (FEV1 and FVC >75% of predicted and FEV1/FVC >0.65).
  • Ability to complete the exposure exercise regimen chosen to induce a ventilation rate of 15 to 17 L/min/m2 without exceeding 80% of predicted maximal heart rate.
  • Normal baseline 12-lead resting ECG, and absence of significant ST depression while performing the 15-minute required level of exercise targeted for the exposure period.
  • Subjects must be able to avoid certain medication supplements listed for 1 week before the exposure.

Exclusion Criteria:

  • Non-English speaking.
  • Including, but not limited to as ascertained by the physicians: Subjects with chronic cardiovascular (such as ischemic heart disease) or respiratory (such as asthma or COPD) disease; diabetes, or other organ or system dysfunction; cerebrovascular disease; active psychiatric disorders that would interfere with the subject's ability to understand and participate in the study. Subjects who have tested positive for a disease that affects the immune system (such as HIV, lymphoma, leukemia) or current drug or alcohol abuse (defined as having more than 3 drinks per day or being unable to abstain from alcohol for 3 days).
  • Subjects with atopy or allergic rhinitis will not be excluded as long as they do not require regular treatment with antihistamines or systemic steroids.
  • Ever-smokers (smoked tobacco or marijuana during the last five years, or with history of >10 pack year for tobacco or > 1 joint year for marijuana, or living with a smoker who smokes inside the house).
  • Subject having plasma cotinine level > 3ng/mL.
  • BMI >35 or <18 (35 is the official cut off for class 1 obesity).
  • Hypertension (defined as blood pressure >140 systolic or >90diastolic) or on anti-hypertension medications other than diuretics.
  • Pregnancy or nursing (breastfeeding).
  • On the following medications: prednisone, statins, beta-blockers, anticoagulants, current hormonal therapy, tamoxifen. Subjects will not be asked to discontinue needed prescription medications for the purpose of this study. If any of these medications becomes necessary during the course of the study, the subjects will be excluded. Use of other medications will be considered on an individual basis.
  • Subjects taking aspirin or PDE5 inhibitors must be willing to abstain from these medications during the week preceding each exposure.
  • Occupational exposures (exposed to high levels of vapors, dust, gases, or fumes on an on-going basis)

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Tidsperspektiver: Potensielle

Kohorter og intervensjoner

Gruppe / Kohort
elderly subjects
Healthy

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in endothelial function
Tidsramme: Baseline (16 hours before exposure) and 4 hours after exposure
Brachail artey flow-mediated dilation and nitroglycerin-mediated dilation
Baseline (16 hours before exposure) and 4 hours after exposure
Change in heart rate variability
Tidsramme: Baseline (0.5 hours before exposure) and 0.2, 2, and 21.5 after exposure
measured with Holter monitor
Baseline (0.5 hours before exposure) and 0.2, 2, and 21.5 after exposure
Change in prothrombotic vascular state
Tidsramme: Baseline (17 hour before exposure) and 3.5 and 22 hours after exposure
Peripheral blood samples will be taken and stored as plasma for measurement of von Willenbrand Factor antigen
Baseline (17 hour before exposure) and 3.5 and 22 hours after exposure
Change in cardiac repolarization
Tidsramme: Baseline (0.5 hours before exposure) and 0.2, 2, and 21.5 after exposure
from Holter monitor
Baseline (0.5 hours before exposure) and 0.2, 2, and 21.5 after exposure

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in markers of systemic inflammation
Tidsramme: Baseline (17 hour before exposure) and 3.5 and 22 hours after exposure
Peripheral blood samples will be taken and stored as plasma for measurements of inflammatory markers
Baseline (17 hour before exposure) and 3.5 and 22 hours after exposure
Change in lung function
Tidsramme: Baseline (0.2 hours before exposure) and 0.5, 3, and 22.5 hours after exposure
Spirometry
Baseline (0.2 hours before exposure) and 0.5, 3, and 22.5 hours after exposure
Lung inflammation
Tidsramme: 22 hours after exposure
A sputum sample will be obtained and stored for measurement of inflammatory mediators
22 hours after exposure

Samarbeidspartnere og etterforskere

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

Sponsor

Health Effects Institute

Samarbeidspartnere

University of California, San Francisco
University of North Carolina, Chapel Hill
HealthCore-NERI
University of Rochester

Etterforskere

  • Hovedetterforsker: Anne Stoddard, PhD, HealthCore-NERI

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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. januar 2012

Primær fullføring (Forventet)

1. desember 2014

Studiet fullført (Forventet)

1. desember 2014

Datoer for studieregistrering

Først innsendt

1. desember 2011

Først innsendt som oppfylte QC-kriteriene

5. desember 2011

Først lagt ut (Anslag)

7. desember 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

11. juni 2012

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. juni 2012

Sist bekreftet

1. juni 2012

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 10-01-4

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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Forhold

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