Clinical trial NCT05198492: Short- and Long-term Health Effects of Air Pollution in Poland
Official title: Short- and Long-term Health Effects of Air Pollution in Poland
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Coronary Syndrome
Atrial Fibrillation
Kidney Diseases
Particulate Matter Inhalation Injury
Pollution; Exposure
Oxidative Stress
Ischemic Stroke
Keywords: Air Pollution
Public Health
Acute Coronary Syndromes
Atrial Fibrillation
Kidney Diseases
Particulate Matter
Cardiovascular Diseases
Lead sponsor: Medical University of Bialystok
Sponsor class: OTHER
Collaborators: name: Charles University, Czech Republic
name: University of Liverpool
name: University of Skopje
name: University of Lodz
First posted: 2022-01-20
Enrollment: 8300000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be based on residents of Eastern Poland. This term covers 5 voivodships - Warmińsko-Mazurskie, Podlaskie, Lubelskie, Świętokrzyskie, Podkarpackie - with total area of 99,004 km2. The inhabitants of this region constitute 21.3% of the population of Poland and 1.6% of the population of the European Union. The area characterized by unique natural features, large areas covered by forests, lack of factories, and relatively low industrialization is not free of air pollution. As 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.

Brief 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.

Detailed 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, ischemic strokes, kidney disease hospitalizations or emergency room visits, cardiovascular and renal mortality.

Eligibility criteria: Inclusion Criteria:

* Residents from the analyzed area

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of acute coronary syndromes related to the impact of air pollution.
timeFrame: Through study completion, an average of 1 year
measure: Number of atrial fibrillation episodes related to the impact of air pollution.
timeFrame: Through study completion, an average of 1 year
measure: Number of hospitalizations due to kidney diseases related to the impact of air pollution.
timeFrame: Through study completion, an average of 1 year
measure: Number of hospitalizations due to acute kidney diseases related to the impact of air pollution.
timeFrame: Through study completion, an average of 1 year
measure: Number of patients under hemodialysis related to the impact of air pollution.
timeFrame: Through study completion, an average of 1 year
measure: Number of ischemic strokes related to the impact of air pollution.
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Cardiovascular mortality
timeFrame: Through study completion, an average of 1 year
measure: Neoplasm mortality
timeFrame: Through study completion, an average of 1 year
measure: Kidney disease mortality
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Białystok
country: Poland
facility: Department of Invasive Cardiology, Medical University of Bialystok
state: Podlaskie
Study officials:
affiliation: Medical University of Bialystok
name: Łukasz Kuźma
role: STUDY_DIRECTOR
References:
citation: 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.
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.
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.
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.
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.
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.
citation: Kuzma L, Dabrowski EJ, Kurasz A, Swieczkowski M, Jemielita P, Kowalewski M, Wanha W, Kralisz P, Tomaszuk-Kazberuk A, Bachorzewska-Gajewska H, Dobrzycki S, Lip GYH. Effect of air pollution exposure on risk of acute coronary syndromes in Poland: a nationwide population-based study (EP-PARTICLES study). Lancet Reg Health Eur. 2024 Apr 22;41:100910. doi: 10.1016/j.lanepe.2024.100910. eCollection 2024 Jun.
citation: Swieczkowski M, Dobrzycki S, Kuzma L. Multi-City Analysis of the Acute Effect of Polish Smog on Cause-Specific Mortality (EP-PARTICLES Study). Int J Environ Res Public Health. 2023 Apr 18;20(8):5566. doi: 10.3390/ijerph20085566.