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Search / Trial NCT05843370

Modification of Ambient Air Pollution Exposure and Cardiopulmonary Outcomes by Socioeconomic Status and Nutrition

Launched by ENVIRONMENTAL PROTECTION AGENCY (EPA) · May 2, 2023

Trial Information

Current as of June 26, 2025

Enrolling by invitation

Keywords

ClinConnect Summary

Acute and chronic exposure to air pollution are well-established risk factors for all-cause mortality, mainly driven by cardiovascular and respiratory disease. The health effects of air pollution exposure have been shown to be mediated by a range of community level and personal factors, including the presence of preexisting medical conditions, age, and socioeconomic status (SES). Individuals who reside in lower SES communities are more likely to experience increased air pollution. The effects of air pollution among those residing in less advantaged communities may be further compounded by r...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Aged 25-70 years old males and females.
  • Residing in Zip Code Tabulation Area in Raleigh-Durham great triangle area representing high or low social vulnerability index (SVI).
  • Continuous residence at the same address during previous one year.
  • Exclusion Criteria:
  • Individuals with a diagnosis of COVID-19 and have persistent symptoms due to that infection (e.g., shortness of breath) or symptoms consistent with "long COVID".
  • Individuals not "up to date" on their vaccinations for COVID-19. \[which means a person who has received all recommended COVID-19 vaccines, including any booster dose(s) when eligible\].
  • Individuals who have difficulty to come to the HSF medical station on a weekday for data collection without assistance.
  • Individuals have a history of heart arrhythmia, a pacemaker user, been diagnosed with arrhythmia and prescribed a medication to treat arrhythmia.
  • Individuals have uncontrolled hypertension (\>180 systolic, \>110 diastolic)
  • Individuals who are currently smoking (including vaping, hookah, e-cigarettes, including marijuana, CBD, and/or THC products) or have a smoking history within 1 year of study (defined as more than 1 pk/yr in the past year) or have a greater than/equal to a 5-pack year smoking history.
  • Individuals living with a smoker who smokes inside the house.
  • Individuals who are regularly exposed to high levels of vapors, dust, gases, smoke, or fumes.
  • Individuals who do not understand or speak English.
  • Individuals who are taking β-blocker medications.
  • Individuals who are on specific extreme diets, such as liquid diet, weight loss diet, or single diet.
  • Individuals who are unwilling or unable to maintain their current dietary and medication pattern for the whole study.
  • Individuals with bleeding or clotting disorders.
  • Individuals who have skin allergy to tape or electrodes.
  • Individuals who are pregnant or attempting to become pregnant.
  • Individuals currently on dialysis
  • Individuals who have unspecified illnesses, which in the judgment of the investigators might increase the risk associated with clinical procedures will be a basis for exclusion.
  • Temporary Exclusion Criteria :
  • Individuals who have had recent (within 6 months) abdominal and/or eye surgery, or been diagnosed with any type of hernia, as well as any other contraindications for raised intra-abdominal pressure.
  • Individuals who have prolonged chest pain at rest (severe uncompensated angina pectoris) or inability to carry out any physical activity without chest discomfort.
  • Individuals who have difficulty breathing when at rest or performing activities at daily living.
  • Individuals who are having an acute respiratory illness within two weeks prior to any of the study visits.

About Environmental Protection Agency (Epa)

The Environmental Protection Agency (EPA) is a U.S. federal agency dedicated to safeguarding human health and the environment through regulatory oversight, research, and public education. As a clinical trial sponsor, the EPA conducts studies to assess the impact of environmental contaminants on public health and ecosystems, utilizing robust scientific methodologies to generate data that informs policy decisions and regulatory frameworks. By fostering collaboration with academic institutions, industry stakeholders, and other governmental entities, the EPA aims to enhance understanding of environmental risks and promote sustainable practices that protect both the environment and public health.

Locations

Chapel Hill, North Carolina, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported