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A Multifaceted Intervention to Mitigate the Adverse Cardiovascular Effects of Air Pollution: A Feasibility Randomized Controlled Trial Publisher



Sadeghipour P1, 2 ; Talasaz AH3, 4, 5 ; Rashedi S6 ; Jamalkhani S1 ; Ghoshouni H1 ; Babaei M1, 7 ; Kohansal E1 ; Mohebbi B1 ; Elahifar A9, 10 ; Omidvar R1 ; Hadavand N1 ; Hassanvand MS9 ; Poopak A1 ; Bakhshandeh H1 Show All Authors
Authors
  1. Sadeghipour P1, 2
  2. Talasaz AH3, 4, 5
  3. Rashedi S6
  4. Jamalkhani S1
  5. Ghoshouni H1
  6. Babaei M1, 7
  7. Kohansal E1
  8. Mohebbi B1
  9. Elahifar A9, 10
  10. Omidvar R1
  11. Hadavand N1
  12. Hassanvand MS9
  13. Poopak A1
  14. Bakhshandeh H1
  15. Mazloomzadeh S1
  16. Kakavand H11
  17. Aghakouchakzadeh M11
  18. Piazza G6, 12
  19. Krumholz HM8, 13, 14
  20. Bikdeli B6, 12, 13
Show Affiliations
Authors Affiliations
  1. 1. Vascular Diseases and Thrombosis Research Center, Rajaie Cardiovascular Medical and Research Institue, Tehran, Iran
  2. 2. Clinical Trial Center, Rajaie Cardiovascular, Medical, and Research Center, Iran University of Medical Sciences, Tehran, Iran
  3. 3. Department of Pharmacotherapy and Outcomes Sciences, Virginia Commonwealth University, Richmond, VA, United States
  4. 4. Department of Pharmacy Practice, Arnold and Marie Schwartz College of Pharmacy and Health Sciences, Long Island University, New York, NY, United States
  5. 5. Department of Pharmacy, New York-Presbyterian Hospital, Columbia University Medical Center, New York, NY, United States
  6. 6. Thrombosis Research Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States
  7. 7. School of Medicine, Tehran University of Medical Sciences, Tehran, Iran
  8. 8. Department of Health Policy and Management, Yale School of Public Health, New Haven, CT, United States
  9. 9. Department of Environmental Health Engineering, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
  10. 10. Center for Air Pollution Research (CAPR), Institute for Environmental Research (IER), Tehran University of Medical Sciences, Tehran, Iran
  11. 11. Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran
  12. 12. Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States
  13. 13. YNHH, Yale Center for Outcomes Research and Evaluation (CORE), New Haven, CT, United States
  14. 14. Section of Cardiovascular Medicine, Yale School of Medicine, New Haven, CT, United States

Source: Journal of Cardiovascular Pharmacology Published:2025


Abstract

Air pollution is associated with excess thrombotic and cardiovascular events. However, clinical outcomes trials evaluating interventions to mitigate such adverse events in patients with atherosclerotic cardiovascular diseases (ASCVD) are lacking. This is a single-center, open-label, feasibility randomized controlled trial (RCT) conducted in adult patients with documented ASCVD. Participants were randomized to a hybrid strategy consisting of an educational flashcard, educational cell phone text message alerts on polluted days to stay indoors, use KN95 masks if they need to go outside, and to consume citrus fruits on polluted days, versus usual care. The main objectives were to assess the feasibility of enrollment and adherence to and satisfaction with the hybrid strategy along with health-related quality of life and anxiety level. Between January 28, 2024, and February 18, 2024, 130 patients were screened, of whom 50 (38.5%) were randomized. During the study period, 12 polluted days occurred, and patients received a median of 8 ((IQR) 8 to 10) alerts. The majority adhered to all components on all polluted days, including full adherence for reading flashcards in 56%, avoiding outdoor activities in 52%, wearing KN-95 facemasks if they went out in 81.8%, and self-reported citrus fruit consumption in 84% of enrollees. The most participants in the intervention arm were satisfied with all components of the hybrid staretgy. Quality of life index and anxiety level remained unchanged for both groups during the 30-day follow-up. This pilot study shows the feasibility of recruitment to multifaceted strategy to mitigate the cardiovascular effects of air pollution with high adherence and satisfaction, thus supporting initiatives to design and conduct a large-scale RCT to validate and extend these findings. Copyright © 2025 Wolters Kluwer Health, Inc. All rights reserved.
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