Feasibility of a Multifaceted Program to Reduce Cardiovascular Complications of Air Pollution

Launched by PARHAM SADEGHIPOUR · Feb 7, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new program designed to help reduce the harmful effects of air pollution on heart health in adults with certain heart conditions, such as atherosclerosis and coronary artery disease. The main goal is to see if this program is practical to implement on a larger scale and to understand how well patients follow it and feel about it.

To participate in this trial, you need to be an adult over 18 years old who has a documented heart condition, like a previous heart attack or surgery related to heart disease. The study is open to all genders, and participants should be willing to wear a mask when outdoors and engage in the program. If you join, you can expect to be part of a supportive environment that helps track your experiences and any challenges you might face while trying to improve your heart health in the context of air pollution. Your feedback will be important for shaping future studies and programs!

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Adult patients (≥18 years) with documented ASCVD defined as at least one of the following:
• * Coronary artery disease (CAD):
• • 1. Previous or recent documented type I myocardial infarction
• • 2. History of coronary revascularization (percutaneous coronary intervention or coronary artery bypass graft surgery)
• • 3. History of obstructive CAD (\>50% stenosis) documented by coronary computed tomography (CT) or conventional angiography
• * Peripheral arterial disease (PAD):
• • 1. Previous or recent acute ischemic limb event (\>7 days prior)
• • 2. History of previous endovascular/surgical lower or upper extremities revascularization for an atherosclerotic cause
• • 3. History of ulcer or lower extremities amputation due to ASCVD.
• * Carotid arterial diseases:
• • 1. History of previous endovascular/surgical carotid artery revascularization for atherosclerotic cause
• • 2. History of \> 50% carotid artery stenosis based on documented imaging tests (Duplex ultrasonography, CT angiography, magnetic resonance angiography, or conventional angiography)
• * Ischemic stroke:
• • 1. 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
• Exclusion Criteria:
• • 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