Cardiovascular Injury Clinical Trial
Official title:
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.
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.
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