Air Pollution and Cardiovascular Disease in Qatar: an Interventional Study to Reduce Blood Pressure: the APCIQ-BP Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Systolic Blood Pressure
研究概览
简要总结
The main objective is to determine if in-home portable air cleaners provide persistent reductions in PM2.5 exposures and improvements in systolic blood pressure and biochemical parameters over 4-weeks in patients with metabolic syndrome residing in Qatar.
详细描述
Chronic cardio-metabolic diseases such as hypertension and diabetes contribute disproportionately to global morbidity and mortality and are increasing believed to have multiple environmental influences.
PM2.5 is the fifth leading risk factor for global mortality - largely due to cardiovascular disease (CVD). Reducing personal exposure to air pollution has shown promise in improving key cardiovascular risk factors (blood pressure and insulin resistance) in limited studies, but durability of these effects is not known. Personal air cleaners have been shown to decrease personal exposure to PM2.5 and reduce blood pressure in small studies and may serve as a pragmatic intervention in high-risk patients in whom air pollution is a strong contributor to cardiovascular health.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-smokers (100% abstinence from use of any smoking or vaping product during the prior year)
- •Age ≥18 and less than 60 years old
- •Living in a single residence (home, apartment) located anywhere in Qatar
- •Mild systolic hypertension: screening visit systolic BP 130 to 159 mm Hg (off treatment or taking ≤ 2 BP medications that have been stable without changes during prior 4 weeks) plus ≥ 2 more additional criteria for the metabolic syndrome:
- •Waist circumference ≥102 cm if male and ≥88 cm if female
- •Fasting triglycerides ≥150 mg/dL (or taking a triglyceride-lowering medication)
- •HDL-C ≤ 40 mg/dL if male and ≤ 50 mg/dL if female (or taking an HDL-raising medication),
- •Fasting glucose ≥100 mg/dL
排除标准
- •Pregnancy (self-reported)
- •Screening visit urine positive for cotinine (NicAlert >100 ng/mL)
- •Living with an active smoker who smokes indoors (by self-report)
- •High risk conditions that prohibit allowing home BP to be >130/80 mm Hg during the10-week trial including any cardiovascular disease (coronary artery disease, prior stroke, heart failure, peripheral arterial disease, aneurysm) or ≥ stage 3 kidney disease (estimated glomerular filtration rate < 60 ml/min)
- •A medical condition placing the participant at risk from participation (per investigators)
- •Expected overnight travel outside their residence during the study
- •HEPA filter within the air conditioners of the residence (self-reported) or individual use of HEPA filter
- •Unable to comprehend/sign an informed consent
- •Lung disease requiring oxygen
- •Cancer receiving treatment
- •Screening visit: BP ≥160/100 mm Hg or fasting blood glucose ≥126 mg/dL and confirmed diabetes with follow-up HbA1c ≥6.5%. If glucose is elevated ≥126 mg/dL but HbA1c<6.5%, they could still participate.
- •Medication changes in past 4 weeks. If participants are on medications for high BP or hyperlipidemia, they will need to have had stable therapy during prior 10 weeks with no planned changes during the study
- •Left upper arm circumference >17 inches as this will make BP levels inaccurate with the home monitor used
- •Acute illness or infectious symptoms within the prior 4 weeks.
研究组 & 干预措施
Sham mode
In home use of portable air cleaners without a High Efficiency Particulate Air (HEPA) filter for 4 weeks.
干预措施: Air cleaners without HEPA filter (Device)
Active mode
In home use of portable air cleaners with a High Efficiency Particulate Air (HEPA) filter for 4 weeks.
干预措施: Air cleaners with HEPA filter (Device)
结局指标
主要结局
Change in Systolic Blood Pressure
时间窗: week 4, week 10
Mean change from baseline in systolic blood pressure
次要结局
- Change in Fasting Glycemia(week 4, week 10)
- Change in Insulin Resistance Index(week 4, week 10)