Responses to Exposure to Low Levels of Concentrated Ambient Particles in Healthy Young Adults

Completed · Not applicable

Conditions studied: Exposure to Pollution

In brief

Purpose: To determine whether exposure to levels of fine particles that are close to the current standard will cause cardiovascular changes in healthy individuals.

Key facts

Study ID

NCT03232086

Run by

Environmental Protection Agency (EPA)

People needed

20

Starts

2017-01-16

Expected to finish

2020-07-30

Last updated by the study team

2021-09-05

Who can join

Age: 18 and older, up to 35. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy individuals ages 18-35 years of age
• Physical conditioning allowing intermittent, moderate exercise for four hours. Ability to complete the exposure exercise regimen without reaching 80% of predicted maximal heart rate. Predicted maximal heart rate will be calculated using the equation (described by Tanaka et al.: [2001] J. Am. Coll. Cardiol.): [208bpm-((0.7) x (age in years))]
• Normal baseline 12-lead EKG .
• Normal lung function
• Forced vital capacity (FVC) ≥ 80% of that predicted for gender, ethnicity, age and height (according to NHANESIII guidelines).
• Forced expiratory volume in one second (FEV1) ≥ 80%of that predicted for gender,ethnicity, age and height
• FEV1) /FVC ratio≥ 80% of predicted values.
• Oxygen saturation ≥ 96% on room air.

You may not qualify if…

• Individuals with a history of acute or chronic cardiovascular disease, chronic respiratory disease, diabetes, rheumatologic diseases, or immunodeficiency state.
• Individuals with a CVD risk score greater than 10% using the ACC/AHA ASCVD risk calculator.
• Individuals with clinically diagnosed asthma.
• Individuals who are allergic to chemical vapors or gases.
• Females who are pregnant, attempting to become pregnant, or breastfeeding.
• Individuals that are unable or unwilling to stop for at least two weeks prior to the study taking medications, vitamins or supplements that the investigators believe may impact the results of the study. Those not specifically mentioned here may be reviewed by the investigators prior to an individual's inclusion in the study.
• Individuals who smoke/vape more than 2 times per month and have smoked/vaped within 4 weeks prior to all study visits.
• Individuals living with a smoker who smokes inside the house.
• Individuals with a body mass index (BMI) >35 or <18. Body mass index is calculated by dividing the weight in kilograms by the square of the height in meters.
• Individuals with occupational exposures to high levels of vapors, dust, gases, or fumes on an on-going basis.
• Individuals with uncontrolled hypertension (≥150 systolic or ≥90 diastolic).
• Individuals that do not understand or speak English.
• Individuals that are unable to perform the exercise required for the study.
• Individuals that are taking beta blocker medications.
• Individuals with a history of skin allergies to adhesives used in securing EKG electrodes.
• Individuals with unspecified diseases, conditions, or medications that might influence the responses to the exposures, as judged by the medical staff.
• Individuals that are unwilling or unable to stop taking over-the-counter pain medications such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), or other non-steroidal anti-inflammatory ("NSAID") medications for 48 hours prior to the exposures and post-exposure visits.
• Individuals that are taking systemic steroids or beta-blocker medications.
• Individuals with a hemoglobin A1c (HbA1c) level > 6.4%.
• Temporary Exclusion Criteria:
• Individuals suffering from acute respiratory illness within four weeks prior to any of the study exposure series.
• Individuals that have been exposed to smoke and fumes within 24 hours of any study visit.
• Individuals that have engaged in strenuous exercise within 24 hours of any study visit.
• Individuals that have been exposed to ozone-based home air purifiers within 24 hours of any study visit.
• Individuals unable to avoid drinking alcohol for 24 hours prior to all study visits.

Where it is running

• U.S. EPA Human Studies Facility — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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