Cardiovascular Effects of Exposure to Wood Smoke in Healthy Human Adults
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in polymorphonuclear neutrophils (PMN%) in the Sputum
研究概览
简要总结
MASKOFF Clinical Trials 8/22/23
Brief Summary:
Purpose: The study is designed to investigate cardiovascular effects of young healthy human subjects exposed to wood smoke.
Participants: Approximately 80 young (18-35 years old) healthy subjects to complete.
Procedure (methods): After consenting to participate in the study, subjects will be exposed first to filtered air and on the next exposure day to approximately 500 µg/m^3 wood smoke. Both exposures will be 2 hours long with alternating 15 min of exercise (cycle ergometer) and 15 min rest period. The exercise level will be adjusted to achieve approximately 20 L/min/m^2 minute ventilation. Venous blood samples and measurements of lung, cardiac and vascular function will be made prior to and immediately following each exposure. Induced sputum samples and nasal epithelial lining fluid will be collected approximately 24 hours post each exposure.
详细描述
Wood smoke pollution is a common problem across the world, including in the US. This wood smoke comes from people using wood to heat and cook, as well as from wildfires. The purpose of this research study is to investigate the cardiovascular effects of exposure to wood smoke in young, healthy human subjects. Results from this study will also increase understanding of how wood smoke exposure adversely affects the functioning of the human cardiovascular and respiratory systems. This understanding may be especially important for patients with cardiopulmonary diseases.
There is a likelihood that due to scheduling conflicts and other unexpected scenarios (such as government shutdowns etc.) that the time between consenting and participation could be delayed, although every effort will be made to accommodate subjects without hurting the integrity of the study. There will be 5 sessions, including a consenting session which will last for about 5 hours. The two exposure-day sessions will last approximately 8-9 hours each and will occur 48 hours apart. There will also be two follow-up visits lasting approximately 4-hours each on the day following the participants' last exposure.
Before consenting to be part of this study, the potential participant must read all consent forms in entirety. The research and medical staff will then answer all of the participants' questions and explain the risks involved in this study to satisfaction.
The participant should have already undergone a general physical examination to ensure that said participant is a suitable candidate for this study. Participants who were assigned female at birth will be asked about menstrual history and a pregnancy test will be performed. This will be repeated on each exposure day if more than 7 days have lapsed since the last pregnancy test at the HSF.
Consenting Day:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None (Participant)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-35 years old , healthy, with a Body Mass Index (BMI, kg/m^2) values ≥ 19 and ≤ 34, inclusive).
- •Physical conditioning that allows intermittent, mild exercise for approximately 60 min during a 2 hour exposure session. The volunteer must be able to complete the exposure exercise regimen at a workload sufficient to induce a minute ventilation rate of approximately 20 L/min/m^2 for 15 min without exceeding 80% of projected maximal heart rate.
- •Normal ECG.
- •Normal lung function based on NHANES III reference values. i. Forced vital capacity (FVC) ≥ 80% of that predicted for age, gender, ethnicity, and height.
- •ii. Forced expiratory volume in one second (FEV1) ≥ 80% of that predicted for age, gender, ethnicity, and height.
- •iii: FEV1/FVC ratio ≥ 70% (absolute value)
- •Oxygen saturation greater than 94% at the time of physical exam.
排除标准
- •Individuals with the following conditions:
- •A history of acute or chronic cardiovascular disease, chronic respiratory disease, cancer, rheumatologic disease, neuromuscular disease, or immunodeficiency state.
- •BMI (kg/m^2) values < 19 and >
- •Blood pressure readings ≥ 140 systolic and/or ≥ 90 diastolic.
- •Diabetes (previously diagnosed or with hemoglobin A1c level equal to or greater than 6.4%).
- •Asthma or a history of asthma.
- •Bleeding/clotting disorders.
- •Individuals with a cardiovascular disease risk score greater than 10% using the ACC/AHA ASCVD risk calculator. (Based on the 10-year risk of heart disease or stroke using the Atherosclerotic Cardiovascular Disease algorithm published in 2013 American College of Cardiology/American Heart Association Guideline on the Assessment of Cardiovascular risk.)
- •Individuals who have unspecified illnesses, which in the judgment of the medical staff might increase the risk associated with wood smoke inhalation will be a basis for exclusion.
- •Individuals who have had recent (within 6 months) abdominal an/or eye surgery, or with any types of hernia, as well as any other contraindicators for raised intra-abdominal pressure.
- •Individuals who are currently taking systemic steroids or oral anticoagulants long term.
- •Individuals who are taking prescribed medications such as ß-blocker medications, that may impact the results of wood smoke challenge for the duration of the study. Other medications not specifically mentioned here may be reviewed by the medical staff prior to an individual's inclusion in the study. Use of other medications will be evaluated on a case-by-case basis. There is the potential that an individual's current medication use will preclude them from participating in the study at the current time, but they may be reassessed and potentially rescheduled for participation later based on the judgement of the medical staff.
- •Individuals who are allergic to:
- •Chemical vapors or gases.
- •Tape or electrodes on their skin.
- •Or individuals with active allergies or currently experience allergy related symptoms
- •Individuals who are pregnant, attempting to become pregnant or breastfeeding.
- •Individuals who are currently smoking (including vaping, hookah and e-cigarette) or have smoking history within 1 year of study or have an equal to greater than or 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, or fumes.
- •Individuals who do not read, speak, or understand English well enough to give informed consent.
- •Individuals that are unable to perform the exercise required for the study.
- •Individuals who are unwilling or unable to stop taking any current dietary supplements or vitamins for the duration of the study.
- •Individuals currently taking prebiotics, probiotics, or antihistamines.
- •Individuals who have experienced an acute respiratory illness within the last 6 weeks.
- •Individuals that will NOT comply with the following requirements:
- •Avoid smoke and fumes for 24 hours before all visits.
- •Avoid exposure to unvented household combustion sources (gas stoves, lit fireplaces, oil/kerosene heaters) for 48 hours before all visits.
- •Avoid over-the-counter pain medications such as aspirin, Advil, Aleve, or NSAIDs for 48 hours before all visits.
- •Avoid drinking alcohol 34 hours before all visits
- •Avoid strenuous exercise for 24 hours prior to an after all visits.
- •Eat a light breakfast and low-fat lunch on the exposure day.
- •Refrain from eating pan fried and/or grilled foods 12 hours prior to the exposure days.
- •Refrain from consuming caffeine for 12 hours prior to all study visits.
- •Refrain from consuming food 2 hours prior to the consenting and follow up sessions, as this may interfere with induced sputum collection.
- •Wear a N95 mask during all visits to the HSF. A mask will be provided to participants upon check-in.
- •Since examining changes of cells in the induced sputum is an important test for this study, if a subject is a non-producer, or if the quality of their sputum sample does not meet the requirements, they will be disqualified and imbursed for participation up to this point.
研究组 & 干预措施
Controlled Exposure
All subjects will be exposed to both air containing wood smoke and filtered air for 2 hours with alternating 15 minutes of exercise (cycle ergometer) and rest.
干预措施: Filtered Air (Other)
Controlled Exposure
All subjects will be exposed to both air containing wood smoke and filtered air for 2 hours with alternating 15 minutes of exercise (cycle ergometer) and rest.
干预措施: Wood Smoke (Other)
结局指标
主要结局
Change in polymorphonuclear neutrophils (PMN%) in the Sputum
时间窗: Day 1, Day 3, Day 5
Airway inflammation will be assessed by the % PMN in the sputum
次要结局
- Change in Forced Expired Volume in the First Second (FEV1) (liter)(Day 1, Day 2, Day 3, Day 4, Day 5)
- Change in Forced Vital Capacity (FVC) (liter)(Day 1, Day 2, Day 3, Day 4, Day 5)
- Change in Blood Fatty Acids (ng/mL)(Day 2, Day 3, Day 4, Day 5)
- Change in Blood Cholesterol (ng/mL)(Day 2, Day 3, Day 4, Day 5)
- Change in Cytokines in Nasal Epithelial Lining Fluid (NELF) (ng/mL)(Day 1, Day 2, Day 3, Day 4, Day 5)
- Change in Diameters (mm) of Retinal Arteries and Veins(Day 2, Day 3, Day 4, Day 5)
- Percent Change in Heart Rate Variability(Day 2, Day 3, Day 4, Day 5)
- Change in interleukin-6, interleukin-8, interleukin-1 beta, and tumor-necrosis factor alpha in blood. (pg/mL)(Day 2, Day 3, Day 4, Day 5)
- Change in C-reactive protein in blood. (mg/dL)(Day 2, Day 3, Day 4, Day 5)