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.

抽象的 心血管疾病（CVD）是美国死亡的主要原因。越来越多 认识到细颗粒污染（PM2.5）对CVD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生物标志物的改善。但是，尚未评估这些是否 长期过滤会持续或进一步改善短期影响。拟议的研究是最长的 干预试验研究了在住宅中使用低成本空气净化器对改善的影响 脆弱个体的动脉粥样硬化进展。该研究将检查对动脉瘤的反应 HEPA过滤跨四个亚组男性或女性以及西班牙裔或非西班牙裔参与者。 我们将利用洛杉矶的不同人口来研究室内PM2.5对两者的影响 动脉粥样硬化生物标志物（包括动脉刚度，血压）的水平和变化的水平和斜率 促炎和血栓形成标记物以及新型的蛋白质组学制造商以及CVD风险评分。重点 随着时间的流逝，变化的斜率是新颖的，将更好地预测未来的CVD事件和死亡率 比以前的研究评估的生物标志物水平变化。我们有一个经验丰富的调查员团队 南加州大学（USC）和杜克大学，将利用丰富的患者资源 USC Keck电子病历和链接的人口普查PM2.5数据招募100名参与者 65-84岁的非吸烟者患有缺血性心脏病病史（临床稳定至少6个月） 在过去几年中，居住在人口普查轨道上，周围的PM2.5暴露较高。参与者将是障碍 随机分为两个干预臂（HEPA或假过滤，每个持续时间为9个月），并越过 3个月冲洗期后的另一个干预臂。这种设计使我们能够进行两种干预 连续两年的同一日历月份的武器。每次将进行三次家庭访问 干预臂以设置和校准空中监视器，测量健康结果并收集生物测量。 生活方式和健康协变量将通过在线问卷收集。跨界设计和时机 - 受控干预措施将减少混杂因素的影响，因为参与者是自己的 人身内比较中的控件。将测量室内和室外PM2.5以及共污染物；和 在整个试验中将记录气象数据和野火事件。这些协变量将是 在统计分析中进行了调整。我们的目标与非HL-20-788的目标相符 研究便携式空气清洁剂对减少PM2.5暴露和CVD生物标志物的影响 奥米斯标记。拟议研究的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，以进一步调查对不良CVD事件发生率的空气过滤效果 死亡。