Cardiovascular Effects of Exposure to Ozone

NCT01487005 | Unknown

• 1 other identifier: 10-01-4
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Cardiovascular Injury

Keywords

ozone; air pollution; vascular function; cardiac function; inflammation

Outcome Measures

Primary Outcomes (4)

• Change in endothelial function

  Brachail artey flow-mediated dilation and nitroglycerin-mediated dilation

  Baseline (16 hours before exposure) and 4 hours after exposure

• Change in heart rate variability

  measured with Holter monitor

  Baseline (0.5 hours before exposure) and 0.2, 2, and 21.5 after exposure

• Change in prothrombotic vascular state

  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

  from Holter monitor

  Baseline (0.5 hours before exposure) and 0.2, 2, and 21.5 after exposure

Secondary Outcomes (3)

• Change in markers of systemic inflammation

  Baseline (17 hour before exposure) and 3.5 and 22 hours after exposure

• Change in lung function

  Baseline (0.2 hours before exposure) and 0.5, 3, and 22.5 hours after exposure

• Lung inflammation

  22 hours after exposure

Study Arms (1)

elderly subjects

Healthy

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Health Effects Institute: lead
• Carelon Research: collaborator
• University of California, San Francisco: collaborator
• University of North Carolina, Chapel Hill: collaborator
• University of Rochester: collaborator

Study Sites (4)

University of California at San Francisco

San Francisco, California, 94143, United States

RECRUITING

New England Research Institutes, Inc.

Watertown, Massachusetts, 02472, United States

ACTIVE NOT RECRUITING

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 32125874 DERIVED

• 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.

  PMID: 29232153 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anne Stoddard, PhD

  Carelon Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria G Costantini, PhD

CONTACT

617-488-2302; mcostantini@healtheffects.org

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2011
• First Posted: December 7, 2011
• Study Start: January 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 11, 2012

Record last verified: 2012-06

Locations

US (4)