Slowing Atherothrombosis Progression through Indoor Air Filtration: A Crossover Trial in Hispanic and non-Hispanic Adults with Ischemic Heart Disease History

通过室内空气过滤减缓动脉粥样硬化血栓形成的进展：对有缺血性心脏病史的西班牙裔和非西班牙裔成年人进行的交叉试验

• 批准号: 10688095
• 负责人: Zhanghua Chen
• 金额: $ 65.66万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10688095
• 关键词: Acceleration; Acute; Adult; Adverse effects; Age; Aging; Air; Air Pollution; Area; Atherosclerosis; Biological Markers; Blood Glucose; Blood Pressure; Blood coagulation; C-reactive protein; Calendar; Calibration; California; Cardiometabolic Disease; Cardiovascular Diseases; Cause of Death; Censuses; China; Clinical; Computerized Medical Record; Cross-Over Studies; Cross-Over Trials; Crossover Design; Data; Devices; Diabetes Mellitus; Double-Blind Method; Elderly; Enrollment; Environmental Risk Factor; Ethnic Origin; Event; Exposure to; Female; Filtration; Future; Goals; Health; Heart failure; Hispanic; Hispanic Populations; Home visitation; In Vitro; Incidence; Individual; Inflammatory; Interleukin-6; International; Intervention; Intervention Trial; Life; Life Style; Link; Los Angeles; Measures; Methods; Minority Groups; Monitor; Morbidity - disease rate; Multicenter Trials; Myocardial Infarction; Myocardial Ischemia; Not Hispanic or Latino; Older Population; Outcome; P-Selectin; Participant; Particulate; Patients; Persons; Physiologic pulse; Plasma; Pollution; Population Heterogeneity; Populations at Risk; Predisposition; Process; Proteomics; Questionnaires; Randomized; Recording of previous events; Research Design; Research Personnel; Risk; Risk Factors; Sampling; Specific qualifier value; Statistical Data Interpretation; Stroke; Subgroup; Sudden Death; Teenagers; Thrombosis; Time; United States; United States National Institutes of Health; Universities; University resources; Variant; Vulnerable Populations; Wildfire; Woman; air cleaner; air filtration; air monitoring; arterial stiffness; atherothrombosis; burden of illness; cardiovascular disorder risk; cardiovascular risk factor; cost; design; efficacy evaluation; efficacy testing; epidemiology study; ethnic diversity; experience; feasibility trial; fine particles; high efficiency particulate air filter; improved; in vivo; indexing; indoor air; indoor particulate matter; interest; male; men; meteorological data; mortality; non-smoker; novel; pollutant; portability; prevent; primary outcome; residence; response; secondary outcome; sex; systemic inflammatory response; treatment arm; trial comparing; von Willebrand Factor

ABSTRACT Cardiovascular disease (CVD) is the leading cause of death in the US. There has been an increasing recognition of the important contribution of fine particulate pollution (PM2.5) to CVD morbidity and mortality. Mounting evidence suggests that the use of indoor air filtration to reduce PM2.5 exposure from days to weeks leads to improvement in acute atherothrombosis biomarkers. However, no trials have assessed whether these short-term effects are sustained or further improved with prolonged filtration. The proposed study is the longest intervention trial investigating the effect of using low-cost air purifiers in residences on ameliorating atherothrombosis progressions in vulnerable individuals. The study will examine atherothrombosis responses to HEPA filtration across and within four subgroups of male or female and Hispanic or non-Hispanic participants. We will leverage the diverse population in Los Angeles to investigate the effect of indoor PM2.5 filtration on both levels and slopes of change in atherothrombosis biomarkers including arterial stiffness, blood pressure, targeted proinflammatory and prothrombotic markers, and novel proteomic makers, as well as CVD risk score. The focus on the slopes of change over time is novel and will provide better prediction of future CVD events and mortality than biomarker level changes assessed in previous studies. We have an experienced team of investigators at the University of Southern California (USC) and Duke University and will leverage the rich patient resource from the USC KECK electronic medical records and the linked census-track PM2.5 data to enroll 100 participants of 65-84 years old non-smokers with a history of ischemic heart disease (clinically stable for at least 6 months) who have lived in the census track with higher ambient PM2.5 exposure in the past years. Participants will be block- randomized to two intervention arms (HEPA or sham filtrations, each of 9-month duration) and crossed over to the other intervention arm after a 3-month washout period. This design allows us to conduct the two intervention arms in the same calendar months of two consecutive years. Three home visits will be conducted during each intervention arm to set-up and calibrate air monitors, measure health outcomes, and collect biospecimens. Lifestyle and health covariates will be collected through online questionnaires. The crossover design and timing- controlled interventions will reduce the influence of confounding factors since participants serve as their own controls in the within-person comparison. Indoor and outdoor PM2.5 and co-pollutants will be measured; and meteorological data as well as wildfire events will be recorded throughout the trial. These covariates will be adjusted for in the statistical analyses. Our aims match the goal of NOT-HL-20-788 calling feasibility trials to investigate the effects of portable air cleaners on reducing PM2.5 exposure and CVD biomarkers including novel omics markers. Findings of the proposed study will provide the efficacy and feasibility data to support future nationwide or multi-center trials to further investigate the air filtration effect on adverse CVD event incidence and mortality.

摘要 心血管疾病(CVD)是美国人的主要死亡原因。有越来越多的人 认识到细颗粒物污染(PM2.5)对心血管疾病发病率和死亡率的重要贡献。 越来越多的证据表明，使用室内空气过滤将PM2.5暴露从几天减少到几周 导致急性动脉粥样硬化血栓形成生物标志物的改善。然而，还没有试验评估这些 长期过滤可持续或进一步改善短期效果。拟议的研究是时间最长的 居住区使用低成本空气净化器改善效果的干预试验研究 动脉粥样硬化血栓形成在易患个体中的进展。这项研究将检查动脉粥样硬化血栓形成对 HEPA在男性或女性以及西班牙裔或非西班牙裔参与者的四个亚组中进行筛选。 我们将利用洛杉矶多样化的人群来调查室内PM2.5过滤对两者的影响 动脉粥样硬化血栓形成生物标志物的水平和斜率，包括动脉僵硬、血压、靶向 促炎和血栓前标志物，以及新的蛋白质组标志物，以及心血管疾病风险评分。焦点 对随时间变化的斜率的预测是新颖的，将为未来的心血管事件和死亡率提供更好的预测 而不是先前研究中评估的生物标记物水平变化。我们有一支经验丰富的调查团队， 南加州大学(USC)和杜克大学，并将利用来自 南加州大学凯克分校的电子医疗记录和关联的人口普查跟踪PM2.5数据，以登记100名参与者 65-84岁，有缺血性心脏病病史(临床稳定至少6个月)的非吸烟者 在过去的几年里生活在环境PM2.5暴露较高的人口普查轨道上。参与者将被封杀- 随机分为两个干预组(HEPA或假过滤，每组持续9个月)，并交叉至 另一支干预臂在3个月的洗涤期后。这种设计允许我们进行两次干预 武器在连续两年的相同日历月内。期间将进行三次家访。 用于安装和校准空气监测仪、测量健康结果和收集生物标本的干预性手臂。 生活方式和健康协变量将通过在线问卷收集。跨界车的设计和定时- 受控干预将减少混杂因素的影响，因为参与者是他们自己的 控制在人与人之间的比较。将测量室内和室外PM2.5和其他污染物；以及 气象数据以及野火事件将在整个试验过程中被记录下来。这些协变量将是 在统计分析中进行了调整。我们的目标符合NOT-HL-20-788呼叫可行性试验的目标 调查便携式空气净化器对降低PM2.5暴露和心血管疾病生物标志物的影响 组学标记。建议的研究结果将提供有效性和可行性数据，以支持未来 全国或多中心试验，进一步调查空气过滤对心血管不良事件发生率和 死亡率。