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Cardiovascular Effects of Exposure to Ozone (MOSES)

8 giugno 2012 aggiornato da: 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.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Anticipato)

90

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • California
      • San Francisco, California, Stati Uniti, 94143
        • Reclutamento
        • University of California at San Francisco
        • Contatto:
        • Investigatore principale:
          • John Balmes, MD
    • Massachusetts
      • Watertown, Massachusetts, Stati Uniti, 02472
        • Attivo, non reclutante
        • New England Research Institutes, Inc.
    • New York
      • Rochester, New York, Stati Uniti, 14642
        • Reclutamento
        • University of Rochester
        • Contatto:
        • Investigatore principale:
          • Mark Frampton, MD
    • North Carolina
      • Chapel Hill, North Carolina, Stati Uniti, 27599
        • Reclutamento
        • University of North Carolina at Chapel Hill
        • Contatto:
        • Investigatore principale:
          • Philip Bromberg, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 55 anni a 70 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Prospettive temporali: Prospettiva

Coorti e interventi

Gruppo / Coorte
elderly subjects
Healthy

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in endothelial function
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in markers of systemic inflammation
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 22 hours after exposure
A sputum sample will be obtained and stored for measurement of inflammatory mediators
22 hours after exposure

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Health Effects Institute

Collaboratori

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

Investigatori

  • Investigatore principale: Anne Stoddard, PhD, HealthCore-NERI

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 gennaio 2012

Completamento primario (Anticipato)

1 dicembre 2014

Completamento dello studio (Anticipato)

1 dicembre 2014

Date di iscrizione allo studio

Primo inviato

1 dicembre 2011

Primo inviato che soddisfa i criteri di controllo qualità

5 dicembre 2011

Primo Inserito (Stima)

7 dicembre 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

11 giugno 2012

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 giugno 2012

Ultimo verificato

1 giugno 2012

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • 10-01-4

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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