Program to Reduce Heart Problems from Air Pollution
Feasibility of a Multifaceted Intervention to Mitigate the Cardiovascular Adverse Effects of Air Pollution: The COATED-AIR Feasibility Trial
This study is testing a new program that helps adults with heart disease reduce the harmful effects of air pollution through alerts, activity tips, and dietary changes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rajaie Cardiovascular Medical and Research Center Academic / other |
| Locations | 1 site (Tehran) |
| Trial ID | NCT06261606 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the feasibility of a multifaceted program designed to mitigate the cardiovascular effects of air pollution in adults with atherosclerotic cardiovascular disease. The program includes strategies such as mobile alerts for air quality, recommendations for outdoor activity limitations, and dietary interventions with specific nutrients. The study aims to assess patient adherence, satisfaction, and any challenges faced during the implementation of this hybrid program. By understanding these factors, the trial seeks to lay the groundwork for a larger-scale clinical trial in the future.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with documented atherosclerotic cardiovascular disease.
Not a fit: Patients without a history of atherosclerotic cardiovascular disease or those under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly reduce cardiovascular complications associated with air pollution exposure.
How similar studies have performed: While individual-level interventions for air pollution effects have been proposed, this specific multifaceted approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tehran
- Rajaie Cardiovascular Medical and Research Center — Tehran, Iran, Islamic Republic of (Recruiting)
Study contacts
- Principal investigator: Parham Sadeghipour, M.D — Rajaie Cardiovascular Medical and Research Center
- Study coordinator: Parham Sadeghipour, MD
- Email: psadeghipour@hotmail.com
- Phone: +989121454319
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.