Using Indoor Air Filtration to Slow Atherothrombosis Progression in Adults With Ischemic Heart Disease History
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: HEPA filtration, Sham filtration.
- Кому может быть актуально
- Состояния в реестре: Air Pollution, Atherosclerosis. Базовые параметры: 65 лет — 84 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Slowing Atherothrombosis Progression Through Indoor Air Filtration: A Crossover Trial in Hispanic and Non-Hispanic Adults With Ischemic Heart Disease History
Обзор
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.
Подробное описание
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.
Вмешательства
- Устройство HEPA filtration
HEPA filters with the capacity to reduce PM2.5 levels - Устройство Sham filtration
Sham filtration use the same appearance of air purifier but with HEPA filter removed.
Первичные конечные точки
- Change in blood pressure [Срок оценки: Blood pressure will be monitored daily during each of the 9-month intervention]
- Change in carotid-femoral pulse wave velocity [Срок оценки: At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions]
- Change in augmentation index [Срок оценки: At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions]
- Change in von Willebrand factor [Срок оценки: At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions]
- Change in P-selectin [Срок оценки: At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions]
Вторичные конечные точки (6)
- Change in fasting glucose [Срок оценки: At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions]
- Change in fasting insulin [Срок оценки: At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions]
- Changes in lipid profiles [Срок оценки: 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 [Срок оценки: At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions]
- Change in interleukin 6 [Срок оценки: 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 [Срок оценки: At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Перекрёстный дизайн
- Маскирование
- Двойное слепое
- Основная цель
- Профилактика
Центры проведения
США · 1 центр
- Keck School of Medicine, University of Southern California — Los Angeles
Идентификаторы
NCT: NCT05867381 · SAPIA_Study · R01ES033707