Feasibility of a Multifaceted Intervention to Mitigate the Cardiovascular Adverse Effects of Air Pollution: The COATED-AIR Feasibility Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Feasibility of conducting the trial
研究概览
简要总结
The main goal of this clinical trial is to evaluate the feasibility of conducting a large-scale clinical trial testing a program containing several aspects for reducing the effects of air pollution on cardiovascular health (which is named the hybrid program hereafter) in adult patients (18 years or older) with atherosclerotic cardiovascular disease. Furthermore, we seek to answer how much patients adhere to and are satisfied with implementing the hybrid program, and what problems executing this program will bring for patients.
详细描述
Background:
Air pollution, as the fourth leading cause of mortality globally, is annually responsible for 6.67 million deaths worldwide and approximately half of them are attributable to cardiovascular causes. Some of the pollutants can negatively affect the cardiovascular system, as they may pass through the lungs, entering into the bloodstream, and cause inflammation and oxidative stress. Exposure to these pollutants is associated with a diverse range of fatal and/or adverse non-fatal cardiovascular events, including myocardial infarction, heart failure, atrial fibrillation, and ischemic stroke.
Besides strategies in societal-level aiming to control the air pollution, various individual-level solutions have been suggested to mitigate the health-related effects of air pollution. Text messaging via mobile phones to alert individuals about unhealthy air quality levels, and recommending to limit activity and time spent in outdoors, use face mask when going out, or use air filtration systems are among these individual-level solutions to restrict the air pollution-related health effects. Furthermore, several studies have proposed dietary interventions and demonstrated that some nutrients, especially vitamins C and E, are potentially capable to counter with the adverse effects of air pollutants on the cardiovascular system. However, the efficacy of these individual-level solutions to reduce the the incidence of clinically relevant outcomes such as myocardial infarction, stroke, and acute limb events.
The current pilot randomized controlled trial (RCT) seeks to test the feasibility and adherence of patients with atherosclerotic cardiovascular diseases (ASCVD) to a multifaceted intervention including a one-page informational flashcard, cell phone message alerting on days with poor air quality to encourage patients not to spend time outdoors, or to wearing KN-95 facemasks outdoors in those days, and encouraging patients to consume citrus fruits on highly polluted days (which is hereafter referred to as hybrid strategy).
Randomization Procedure:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥18 years) with documented ASCVD defined as at least one of the following:
- •Coronary artery disease (CAD):
- •Previous or recent documented type I myocardial infarction
- •History of coronary revascularization (percutaneous coronary intervention or coronary artery bypass graft surgery)
- •History of obstructive CAD (>50% stenosis) documented by coronary computed tomography (CT) or conventional angiography
- •Peripheral arterial disease (PAD):
- •Previous or recent acute ischemic limb event (>7 days prior)
- •History of previous endovascular/surgical lower or upper extremities revascularization for an atherosclerotic cause
- •History of ulcer or lower extremities amputation due to ASCVD.
- •Carotid arterial diseases:
- •History of previous endovascular/surgical carotid artery revascularization for atherosclerotic cause
- •History of > 50% carotid artery stenosis based on documented imaging tests (Duplex ultrasonography, CT angiography, magnetic resonance angiography, or conventional angiography)
- •Ischemic stroke:
- •History of recent or previous documented ischemic stroke not due to systemic hypoperfusion/hypotension being treated with low-dose aspirin
- •Willing to participate and able to provide written informed consent
排除标准
- •Being within 7 days of acute/unstable ASCVD events (acute myocardial infarction, acute limb event, and acute ischemic stroke) or receiving triple antithrombotic therapy
- •Active bleeding
- •History of upper gastrointestinal bleeding within the past 30 days
- •History of intracranial hemorrhage within the past 30 days
- •End-stage kidney disease with estimated creatinine clearance < 15 mL/min, or undergoing hemodialysis or peritoneal dialysis
- •Known aspirin sensitivity without prior successful desensitization
- •Known comorbidities associated with poor prognosis (e.g., metastatic cancer) in conjunction with an estimated life expectancy of less than one year according to the treating clinician
- •Vascular disease known exclusively to be from causes other than atherosclerosis (spontaneous coronary or peripheral dissection (fibromuscular dysplasia, segmental arterial mediolysis) or vasculitis such as Takayasu arteritis, Buerger's disease (i.e., thromboangiitis obliterans), and Churg Strauss syndrome
- •Inherited or acquired severe coagulopathies including hemophilia and decompensated liver cirrhosis
- •Any other unexpected/unwarranted conditions that make the participants unsuitable for recruitment or follow-up
- •Known allergy to KN-95 or other masks, or citrus fruits
- •Any facial dysmorphia that makes the patient unable or unwilling to wear a face mask
- •Any medical condition necessitating unblinded facemask use for outdoor activities at the discretion of the treating clinician, or based on patient preference
- •Inability to receive/read text messages/phone calls by personal mobile phone
- •Unwillingness to participate, such as hesitation to wear a mask, if randomized
研究组 & 干预措施
Hybrid strategy
A hybrid strategy inclusive of:
- A one-page flashcard describing the adverse cardiovascular effects of air pollution and individual-level strategies to mitigate these effects
- Alerting patients on polluted days (defined as air quality index (AQI) ≥ 131 [33]) by sending cell phone text messages and recommending to not go outdoors or minimize outdoor activities (especially exercising) on those days. This will also be accompanied by periodic phone calls to ascertain that the patients receive the messages and are attentive to them.
- Wearing KN-95 facemasks (provided by the investigators of this study) as a physical barrier against air pollution on highly polluted days (defined as AQI ≥ 131) in case the patient cannot avoid going outdoors
- Dietary intervention by encouraging patients to consume citrus fruits during days with AQI ≥ 131.
干预措施: Hybrid strategy (Other)
Usual care
No active strategy (usual care) without any clear recommendations related to air pollution. A control card will be shared with the patients randomized to the control group
结局指标
主要结局
Feasibility of conducting the trial
时间窗: within 30 days
Recruitment rate defined as the proportion of participants randomized divided by the proportion of eligible participants
次要结局
- Patient satisfaction with the hybrid strategy(within 30 days)
- Adherence to the individual components of the hybrid strategy(within 30 days)
- Any potential adverse events in intervention and control groups during the 30-day follow-up(within 30 days)
研究者
Parham Sadeghipour
Associate professor
Rajaie Cardiovascular Medical and Research Center