Feasibility of a Multifaceted Intervention to Mitigate the Cardiovascular Adverse Effects of Air Pollution: The COATED-AIR Feasibility Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Islamic Republic of Iran
Rajaie Cardiovascular Medical and Research Center
RECRUITING
Tehran
Contact Information
Primary
Parham Sadeghipour, MD
psadeghipour@hotmail.com
+989121454319
Time Frame
Start Date: 2024-01-28
Estimated Completion Date: 2024-03
Participants
Target number of participants: 50
Treatments
Experimental: Hybrid strategy
A hybrid strategy inclusive of:~1. A one-page flashcard describing the adverse cardiovascular effects of air pollution and individual-level strategies to mitigate these effects~2. 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.~3. 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~4. Dietary intervention by encouraging patients to consume citrus fruits during days with AQI ≥ 131.
No_intervention: 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
Sponsors
Leads: Parham Sadeghipour

This content was sourced from clinicaltrials.gov