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

2021년 9월 3일 업데이트: David Diaz-Sanchez, Environmental Protection Agency (EPA)
Purpose: To determine whether exposure to levels of fine particles that are close to the current standard will cause cardiovascular changes in healthy individuals.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

Air pollution is associated with several adverse health outcomes. Specifically, ambient fine particulate matter ≤2.5 μg/m3 (PM2.5) is associated with increased mortality and increased risk for respiratory and cardiovascular disease It has been estimated that worldwide over 3.2 million premature deaths and over 74 million years of healthy life lost were attributable to ambient particulate matter pollution, making it one of the top global health risk factors . Further, an estimated 22% of disability-adjusted life-years for heart disease are attributable to ambient particulate matter pollution. Similarly, it is estimated that air pollution exposure contributed to about 6% (3.7 million) of all deaths in 2012, with 40% of those coming from coronary artery disease (CAD). More than 100 time-series and case-crossover analyses have demonstrated associations of short term PM2.5 exposure with myocardial infarctions (MIs); aggravated asthma and increased risk for hospitalizations and mortality. These studies suggest that the acute health effects of air pollution particularly affect infants and children, older adults, and those with underlying disease, such as diabetes and cardiovascular disease (Pope, 2014). In healthy and younger individuals (<65 year old) these same studies observe associations between air pollution and subclinical biomarkers of inflammation, coagulation and oxidative stress but not for any clinical outcomes. This has led the American Heart Association to state that" Despite theoretical statistical risks ascribed to all individuals, this elevated risk from exposure is not equally distributed within a population. At present-day levels, PM2.5 likely poses an acute threat principally to susceptible people, even if seemingly healthy, such as the elderly and those with (unrecognized) existing coronary artery or structural heart disease."

Controlled human exposure studies are a critical component of the health risk assessment for ozone because of their ability to establish exposure-response relationships at low doses and have therefore weighed heavily in deliberations when the U.S. EPA has considered the National Ambient Air Quality Standard (NAAQS). In contrast, for PM2.5, controlled exposure studies have been used primarily to demonstrate biological plausibility. that is the potential for particulate matter to exert extra-pulmonary effects. These studies have shown that healthy volunteers primarily exhibit mild pulmonary inflammation, decreases in heart rate variability and changes in blood factors associated with blood coagulation following exposure to concentrated air particles (CAPs), most show no change in lung function and none result in cardiac arrhythmia. Nearly all these studies have been conducted at realistic but high levels of PM2.5 (typically above 100 µg/m3). Currently the EPA 24-hour fine particle standard is 35µg/m3, a value based predominantly on epidemiologic studies. While epidemiologic studies suggest that similar effects can occur at lower levels, it is difficult for these association studies to conclusively demonstrate because of the problems in disassociating the effects of PM2.5 from other pollutants and confounders. Only a controlled human exposure study can determine directly whether PM2.5 can alter cardiovascular endpoints at lower concentrations. Four hours represents a typical exposure duration to particulate matter during the course of the day.

연구 유형

중재적

등록 (실제)

20

단계

  • 해당 없음

연락처 및 위치

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연구 장소

  • 미국
    • North Carolina
      • Chapel Hill, North Carolina, 미국, 27514
        • U.S. EPA Human Studies Facility

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

Inclusion Criteria:

  • 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

    1. Forced vital capacity (FVC) ≥ 80% of that predicted for gender, ethnicity, age and height (according to NHANESIII guidelines).
    2. Forced expiratory volume in one second (FEV1) ≥ 80%of that predicted for gender,ethnicity, age and height
    3. FEV1) /FVC ratio≥ 80% of predicted values.
  • Oxygen saturation ≥ 96% on room air.

Exclusion Criteria:

  • 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.
  • Individual unable to avoid caffeine for 12 hours prior to all study visits and during each study visit.
  • Individuals that have been exposed to unvented household combustion sources (gas stoves, lit fireplaces, oil/kerosene heaters) within 48 hours of any study visit.
  • Individuals that have been exposed to or have consumed any agent or have undertaken any activity within 24 hours of any study visit that the investigators believe may compromise the results of the study.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 기초 과학
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
가짜 비교기: 깨끗한 공기
깨끗한 공기에 대한 노출은 UNC 캠퍼스의 EPA 인간 연구 시설에 있는 노출 챔버에서 수행됩니다.
다른: Clean Air
Each subject will be exposed to clean air for 4 hours. Subjects will exercise on a bike or treadmill. Each exercise session will consist of a 15 minute exercise interval at a level of up to 25 L/min/m2BSA followed by a 15 minute rest period.
활성 비교기: Concentrated PM2.5
Exposure to PM2.5 will be conducted in an exposure chamber at the EPA Human Studies Facility on the UNC campus.
다른: PM2.5
Each subject will be exposed up to 35-50 μg/m3 PM2.5 for 4 hours. Subjects will exercise on a bike or treadmill. Each exercise session will consist of a 15 minute exercise interval at a level of up to 25 L/min/m2BSA followed by a 15 minute rest period.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Changes in heart rate variability
기간: Pre exposure to 24hours post exposure
10 minute electrocardiogram recording (measured by Holter ECG) in which the
Pre exposure to 24hours post exposure

2차 결과 측정

결과 측정
측정값 설명
기간
1초 만에 강제 만료된 볼륨(FEV1)
기간: 노출 전 ~ 노출 후 24시간
1초의 강제 호기량(FEV1)은 컴퓨터와 연결된 건식 폐활량계에서 수행되는 폐활량계에 의해 결정됩니다.
노출 전 ~ 노출 후 24시간
강제 폐활량
기간: 노출 전 ~ 노출 후 24시간
강제 폐활량(FVC)은 컴퓨터에 연결된 건식 폐활량계에서 수행되는 폐활량계에 의해 결정됩니다.
노출 전 ~ 노출 후 24시간
Index of inflammatory markers
기간: Pre exposure to 24hours post exposure
Index of inflammatory markers is the mean % changes in a basket of factors related to systemic inflammation (IL-6, IL-8, TNF-a, IL-b, CRP) in the blood following exposure to PM2.5 vs. clean air.
Pre exposure to 24hours post exposure

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Environmental Protection Agency (EPA)

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2017년 1월 16일

기본 완료 (실제)

2019년 1월 20일

연구 완료 (실제)

2020년 7월 30일

연구 등록 날짜

최초 제출

2017년 7월 25일

QC 기준을 충족하는 최초 제출

2017년 7월 25일

처음 게시됨 (실제)

2017년 7월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 9월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 9월 3일

마지막으로 확인됨

2021년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • 16-1548

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아니요

IPD 계획 설명

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약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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