Cardiovascular Effects of Exposure to Ozone (MOSES)
8 de junho de 2012 atualizado por: 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.
Visão geral do estudo
Status
Desconhecido
Condições
Descrição detalhada
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:
- 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.
- 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.
- 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:
- 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.
- 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.
- To determine if cardiovascular effects in ozone exposure are correlated with airway inflammatory effects, but not lung function effects.
Tipo de estudo
Observacional
Inscrição (Antecipado)
90
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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California
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San Francisco, California, Estados Unidos, 94143
- Recrutamento
- University of California at San Francisco
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Contato:
- Hofer Wong
- Número de telefone: 415-206-8951
- E-mail: howong@sfghoem.ucsf.edu
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Investigador principal:
- John Balmes, MD
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Massachusetts
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Watertown, Massachusetts, Estados Unidos, 02472
- Ativo, não recrutando
- New England Research Institutes, Inc.
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New York
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Rochester, New York, Estados Unidos, 14642
- Recrutamento
- University of Rochester
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Contato:
- Erika Little
- Número de telefone: 585-275-4163
- E-mail: erika_little@urmc.rochester.edu
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Investigador principal:
- Mark Frampton, MD
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599
- Recrutamento
- University of North Carolina at Chapel Hill
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Contato:
- Martha Almond
- Número de telefone: 919-966-0759
- E-mail: martha_almond@med.unc.edu
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Investigador principal:
- Philip Bromberg, MD
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
55 anos a 70 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
Healthy elderly volunteers living in or around San Francisco, CA, Research Triangle Park, NC, and Rochester, NY
Descrição
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)
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Perspectivas de Tempo: Prospectivo
Coortes e Intervenções
Grupo / Coorte |
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elderly subjects
Healthy
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in endothelial function
Prazo: Baseline (16 hours before exposure) and 4 hours after exposure
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Brachail artey flow-mediated dilation and nitroglycerin-mediated dilation
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Baseline (16 hours before exposure) and 4 hours after exposure
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Change in heart rate variability
Prazo: Baseline (0.5 hours before exposure) and 0.2, 2, and 21.5 after exposure
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measured with Holter monitor
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Baseline (0.5 hours before exposure) and 0.2, 2, and 21.5 after exposure
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Change in prothrombotic vascular state
Prazo: Baseline (17 hour before exposure) and 3.5 and 22 hours after exposure
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Peripheral blood samples will be taken and stored as plasma for measurement of von Willenbrand Factor antigen
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Baseline (17 hour before exposure) and 3.5 and 22 hours after exposure
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Change in cardiac repolarization
Prazo: Baseline (0.5 hours before exposure) and 0.2, 2, and 21.5 after exposure
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from Holter monitor
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Baseline (0.5 hours before exposure) and 0.2, 2, and 21.5 after exposure
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in markers of systemic inflammation
Prazo: Baseline (17 hour before exposure) and 3.5 and 22 hours after exposure
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Peripheral blood samples will be taken and stored as plasma for measurements of inflammatory markers
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Baseline (17 hour before exposure) and 3.5 and 22 hours after exposure
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Change in lung function
Prazo: Baseline (0.2 hours before exposure) and 0.5, 3, and 22.5 hours after exposure
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Spirometry
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Baseline (0.2 hours before exposure) and 0.5, 3, and 22.5 hours after exposure
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Lung inflammation
Prazo: 22 hours after exposure
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A sputum sample will be obtained and stored for measurement of inflammatory mediators
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22 hours after exposure
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Anne Stoddard, PhD, HealthCore-NERI
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Rich DQ, Thurston SW, Balmes JR, Bromberg PA, Arjomandi M, Hazucha MJ, Alexis NE, Ganz P, Zareba W, Thevenet-Morrison K, Koutrakis P, Frampton MW. Do Ambient Ozone or Other Pollutants Modify Effects of Controlled Ozone Exposure on Pulmonary Function? Ann Am Thorac Soc. 2020 May;17(5):563-572. doi: 10.1513/AnnalsATS.201908-597OC.
- Arjomandi M, Balmes JR, Frampton MW, Bromberg P, Rich DQ, Stark P, Alexis NE, Costantini M, Hollenbeck-Pringle D, Dagincourt N, Hazucha MJ. Respiratory Responses to Ozone Exposure. MOSES (The Multicenter Ozone Study in Older Subjects). Am J Respir Crit Care Med. 2018 May 15;197(10):1319-1327. doi: 10.1164/rccm.201708-1613OC.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de janeiro de 2012
Conclusão Primária (Antecipado)
1 de dezembro de 2014
Conclusão do estudo (Antecipado)
1 de dezembro de 2014
Datas de inscrição no estudo
Enviado pela primeira vez
1 de dezembro de 2011
Enviado pela primeira vez que atendeu aos critérios de CQ
5 de dezembro de 2011
Primeira postagem (Estimativa)
7 de dezembro de 2011
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
11 de junho de 2012
Última atualização enviada que atendeu aos critérios de controle de qualidade
8 de junho de 2012
Última verificação
1 de junho de 2012
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 10-01-4
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