Short- and Long-term Health Effects of Air Pollution in Poland

Atrial Fibrillation Clinical Trial

— EP-PARTICLES  

Official title:

Short- and Long-term Health Effects of Air Pollution in Poland

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05198492
• Other study ID #: UMB-KKI-104
• Status: Active, not recruiting
• Start date: January 1, 2022
• Est. completion date: December 1, 2030

Study information

• Verified date: March 2024
• Source: Medical University of Bialystok
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The effects of air pollution on the frequency of hospital admissions and mortality due to acute coronary syndromes, atrial fibrillation, and renal disfunction are noted also in areas perceived as pollution-free (due to the lack of large industry). The aim of the project is to assess the impact of air pollution in Eastern Poland on regional public health.

Description:

The project will be conducted in Eastern Poland - the area characterized by unique natural features, large areas covered by forests, lack of factories, and relatively low industrialization. On the other hand, the region is also characterized by low socioeconomic status, in the cold season the residents' suboptimal heating choices are in result posing a major anthropogenic threat to air quality in the form of low emissions. The vast majority of studies on air pollution were conducted in highly polluted areas, in which patients are exposed to moderate and extreme concentrations of pollutants. Taking into consideration the scarce number of surveys from areas with a low level of pollution the investigators intend to analyze the relationship between air pollution and cardiovascular and renal outcomes in Eastern Poland. The examination of the impact of so-called "Polish smog" on mortality and morbidity in the study area is not without significance. It would be the first major study of the impact of this type of pollution on human health. In the subsequent part of the study, we will evaluate the effects of Polish smog in the entire country. In light of extant body of literature, the following will be considered as the public health indicators: acute coronary syndromes, episodes of atrial fibrillation, kidney disease hospitalizations or emergency room visits, cardiovascular and renal mortality.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8300000
• Est. completion date: December 1, 2030
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Residents from the analyzed area

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Atrial Fibrillation
• Kidney Diseases
• Oxidative Stress
• Particulate Matter Inhalation Injury
• Pollution; Exposure

Intervention

Other:
• Impact of air pollution
To assess the short- and long- term impact of air pollution

Locations

Country	Name	City	State
Poland	Department of Invasive Cardiology, Medical University of Bialystok	Bialystok	Podlaskie

Sponsors (5)

Lead Sponsor	Collaborator
Medical University of Bialystok	Charles University, Czech Republic, University of Liverpool, University of Lodz, University of Skopje

Country where clinical trial is conducted

Poland, 

References & Publications (6)

Kuzma L, Dabrowski EJ, Kurasz A, Bachorzewska-Gajewska H, Dobrzycki S. The 10-Year Study of the Impact of Particulate Matters on Mortality in Two Transit Cities in North-Eastern Poland (PL-PARTICLES). J Clin Med. 2020 Oct 27;9(11):3445. doi: 10.3390/jcm9113445. — View Citation

Kuzma L, Malyszko J, Bachorzewska-Gajewska H, Kralisz P, Dobrzycki S. Exposure to air pollution and renal function. Sci Rep. 2021 Jun 1;11(1):11419. doi: 10.1038/s41598-021-91000-0. — View Citation

Kuzma L, Pogorzelski S, Struniawski K, Bachorzewska-Gajewska H, Dobrzycki S. Exposure to air pollution-a trigger for myocardial infarction? A nine-year study in Bialystok-the capital of the Green Lungs of Poland (BIA-ACS registry). Int J Hyg Environ Health. 2020 Aug;229:113578. doi: 10.1016/j.ijheh.2020.113578. Epub 2020 Aug 3. — View Citation

Kuzma L, Pogorzelski S, Struniawski K, Dobrzycki S, Bachorzewska-Gajewska H. Effect of air pollution on the number of hospital admissions for acute coronary syndrome in elderly patients. Pol Arch Intern Med. 2020 Jan 31;130(1):38-46. doi: 10.20452/pamw.15064. Epub 2019 Nov 19. — View Citation

Kuzma L, Struniawski K, Pogorzelski S, Bachorzewska-Gajewska H, Dobrzycki S. Gender Differences in Association between Air Pollution and Daily Mortality in the Capital of the Green Lungs of Poland-Population-Based Study with 2,953,000 Person-Years of Follow-Up. J Clin Med. 2020 Jul 23;9(8):2351. doi: 10.3390/jcm9082351. — View Citation

Kuzma L, Wanha W, Kralisz P, Kazmierski M, Bachorzewska-Gajewska H, Wojakowski W, Dobrzycki S. Impact of short-term air pollution exposure on acute coronary syndrome in two cohorts of industrial and non-industrial areas: A time series regression with 6,000,000 person-years of follow-up (ACS - Air Pollution Study). Environ Res. 2021 Jun;197:111154. doi: 10.1016/j.envres.2021.111154. Epub 2021 Apr 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of acute coronary syndromes related with impact of air pollution.	Short- and long- term influence of air pollution on the number of hospital admissions for acute coronary syndromes.	Through study completion, an average of 1 year
Primary	Number of atrial fibrillation episodes related with impact of air pollution.	Short- and long- term influence of air pollution on the number of hospital admissions for atrial fibrillation.	Through study completion, an average of 1 year
Primary	Number of hospitalizations due to kidney diseases related with impact of air pollution.	Long- term influence of air pollution on the number of hospital admissions for kidney disease.	Through study completion, an average of 1 year
Primary	Number of hospitalizations due to acute kidney diseases related with impact of air pollution.	Long- term influence of air pollution on the number of hospital admissions for kidney disease.	Through study completion, an average of 1 year
Primary	Number of patients under hemodialysis related with impact of air pollution.	Long- term influence of air pollution on the number of hospital admissions for kidney disease.	Through study completion, an average of 1 year
Secondary	Cardiovascular mortality	Short- and long- term influence of air pollution on the number of cardiovascular mortality.	Through study completion, an average of 1 year
Secondary	Neoplasm mortality	Short- and long- term influence of air pollution on neoplasm mortality.	Through study completion, an average of 1 year
Secondary	Kidney disease mortality	Short- and long- term influence of air pollution on mortality related to renal function.	Through study completion, an average of 1 year