Slowing Atherothrombosis Progression Through Indoor Air Filtration: A Crossover Trial in Hispanic and Non-Hispanic Adults With Ischemic Heart Disease History
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Change in blood pressure
研究概览
简要总结
This double-blind, randomized, crossover trial aims to test the hypothesis that longer-term indoor air filtration intervention can slow atherothrombosis progression by reducing indoor fine particulate matter (PM2.5) exposure in adults with ischemic heart disease history.
详细描述
This double-blind, randomized, crossover trial will recruit 112 adults with ischemic heart disease history and will investigate potential benefits of indoor high efficiency particulate air (HEPA) filtration on ameliorating the progression of atherothrombosis. Participants will be contacted and recruited to the study based on inclusion and exclusion criteria. After consenting, participants will go through a total of 21-month study period comprised of true HEPA filtration and sham filtration, each of 9-month in duration, and a 3-month wash-out period. After 3-month wash-out period, participants will be switched to the other arm of the intervention. During the trial, project specialists will complete a series of home visits before, in the middle, and after each intervention session to set up air purifiers and indoor and outdoor air pollution monitors, as well as conduct interview to collect questionnaire data, measure vascular function, blood pressure, and collect biospecimens. Participants will self-monitor their daily blood pressure through out the intervention periods. In aim 1, researchers will assess the effect of a 9-month residential HEPA intervention on atherothrombosis progression in 112 participants. In aim 2, the researchers will examine the association between reduction in indoor PM2.5 exposure brought by the intervention and the changes in atherothrombosis progression indicators adjusting for outdoor PM2.5 exposure. In aim 3, researchers will examine atherothrombosis responses (both levels and slopes of change) to the HEPA intervention within four subgroups of participants: 1) non-Hispanics, 2) Hispanics, 3) females, and 4) males.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
A sham filter will be used in the control, to replace HEPA filter in the intervention group. Participants and investigators will be blinded to the intervention type, only investigators who will prepare air filters for intervention will be unblinded for the real air filter type.
入排标准
- 年龄范围
- 65 Years 至 84 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 65 and 84 years old;
- •Weight ≥ 110 pounds;
- •Nonsmokers for at least 1 year;
- •Have ischemic heart disease history, clinically stable for 6 months, without any deterioration in symptoms or episodes of angina based on past electronic medical records;
- •Both English and Spanish speaking participants will be included in the recruitment;
- •Live in the Los Angeles County.
排除标准
- •Have history of degenerative disease of the nervous system such as dementia and Alzheimer's;
- •Currently have active cancer treatments;
- •The residential house has already had HEPA filters;
- •Participants will move out from the current residential address in the next 2 years;
- •Participants will spend more than 1 month living outside the primary home;
- •Have any health conditions that prohibit collecting health and covariate data and biospecimens;
- •Participants' residential houses are not feasible for setting up air purifiers and air pollutants monitors.
研究组 & 干预措施
HEPA first and sham
This group of participants will be assigned to the intervention of HEPA filtration with the capacity to reduce indoor PM2.5 levels at their residence for 9 months first. After 3-month wash-out period, participants will be assigned to sham filters (air purifier has the same appearance but HEPA filter is removed) for 9 months.
干预措施: HEPA filtration (Device)
HEPA first and sham
This group of participants will be assigned to the intervention of HEPA filtration with the capacity to reduce indoor PM2.5 levels at their residence for 9 months first. After 3-month wash-out period, participants will be assigned to sham filters (air purifier has the same appearance but HEPA filter is removed) for 9 months.
干预措施: Sham filtration (Device)
Sham first and HEPA
This group of participants will be assigned to the intervention of sham filtration with HEPA filter removed at their residence for 9 months first. After 3-month wash-out period, participants will be assigned to the HEPA filtration for 9 months.
干预措施: HEPA filtration (Device)
Sham first and HEPA
This group of participants will be assigned to the intervention of sham filtration with HEPA filter removed at their residence for 9 months first. After 3-month wash-out period, participants will be assigned to the HEPA filtration for 9 months.
干预措施: Sham filtration (Device)
结局指标
主要结局
Change in blood pressure
时间窗: Blood pressure will be monitored daily during each of the 9-month intervention
Differences between baseline and systolic and diastolic blood pressure measured during and after intervention
Change in carotid-femoral pulse wave velocity
时间窗: At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions
Differences between baseline and carotid-femoral pulse wave velocity measured with Vicorder device during and after intervention
Change in augmentation index
时间窗: At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions
Differences between baseline and augmentation index measured with Vicorder device during and after intervention
Change in von Willebrand factor
时间窗: At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions
Differences between baseline and von Willebrand factor measured during and after intervention
Change in P-selectin
时间窗: At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions
Differences between baseline and P-selectin measured during and after intervention
次要结局
- Change in fasting glucose(At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions)
- Change in C-reactive protein(At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions)
- Change in interleukin 6(At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions)
- Change in fasting insulin(At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions)
- Changes in lipid profiles(At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions)
- Changes in 384 kinds of targeted cardiovascular disease-related proteomic markers(At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions)
研究者
Zhanghua Chen
Assistant Professor
University of Southern California