- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05198492
Short- and Long-term Health Effects of Air Pollution in Poland (EP-PARTICLES)
Study Overview
Status
Conditions
Intervention / Treatment
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, kidney disease hospitalizations or emergency room visits, cardiovascular and renal mortality.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Podlaskie
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Białystok, Podlaskie, Poland, 15-276
- Department of Invasive Cardiology, Medical University of Bialystok
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Residents from the analyzed area
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with hospitalizations or emergency room visits due to acute coronary syndromes
Data on hospitalization for acute coronary syndromes were obtained and extracted from the National Health Fund reports.
In the present analysis, we used data from patients registered as residents in the Podlaskie, Lubelskie, Podkarpackie, Świetokrzyskie, and Warminsko-Mazurskie voivodeships from January 1, 2011 to December 31, 2020.
The set of variables that were subjected to the analysis included demographic features and ICD-10 codes.
The diagnosis was based on reports obtained from to the National Health Fund, and these reports have not been reviewed with patient hospital documentation.
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To assess the short- and long- term impact of air pollution
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Patients with hospitalizations or emergency room visits due to atrial fibrillation
Data on hospitalization for atrial fibrillation were obtained and extracted from the National Health Fund reports.
In the present analysis, we used data from patients registered as residents in the Podlaskie, Lubelskie, Podkarpackie, Świetokrzyskie, and Warminsko-Mazurskie voivodeships from January 1, 2011 to December 31, 2020.
The set of variables that were subjected to the analysis included demographic features and ICD-10 codes.
The diagnosis was based on reports obtained from to the National Health Fund, and these reports have not been reviewed with patient hospital documentation.
|
To assess the short- and long- term impact of air pollution
|
Patients with hospitalizations or emergency room visits due to kidney diseases
Data on hospitalization for kidney diseases were obtained and extracted from the National Health Fund reports.
In the present analysis, we used data from patients registered as residents in the Podlaskie, Lubelskie, Podkarpackie, Świetokrzyskie, and Warminsko-Mazurskie voivodeships from January 1, 2011 to December 31, 2020.
The set of variables that were subjected to the analysis included demographic features and ICD-10 codes.
The diagnosis was based on reports obtained from to the National Health Fund, and these reports have not been reviewed with patient hospital documentation.
|
To assess the short- and long- term impact of air pollution
|
Patients who died due to cardiovascular diseases
Data on mortality were collected from the National Statistical Office in Poland.
These include information on all the deaths recorded in the Podlaskie, Lubelskie, Podkarpackie, Świetokrzyskie, and Warminsko-Mazurskie voivodeships from January 1, 2011 to December 31, 2020 The records included sex and age of people who had died, and the causes of deaths were classified according to codes in the International Classification of Diseases-10th Revision (ICD-10).
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To assess the short- and long- term impact of air pollution
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Patients who died due to neoplasm diseases
Data on mortality were collected from the National Statistical Office in Poland.
These include information on all the deaths recorded in the Podlaskie, Lubelskie, Podkarpackie, Świetokrzyskie, and Warminsko-Mazurskie voivodeships from January 1, 2011 to December 31, 2020 The records included sex and age of people who had died, and the causes of deaths were classified according to codes in the International Classification of Diseases-10th Revision (ICD-10).
|
To assess the short- and long- term impact of air pollution
|
Patients who died due to kidney diseases
Data on mortality were collected from the National Statistical Office in Poland.
These include information on all the deaths recorded in the Podlaskie, Lubelskie, Podkarpackie, Świetokrzyskie, and Warminsko-Mazurskie voivodeships from January 1, 2011 to December 31, 2020 The records included sex and age of people who had died, and the causes of deaths were classified according to codes in the International Classification of Diseases-10th Revision (ICD-10).
|
To assess the short- and long- term impact of air pollution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of acute coronary syndromes related with impact of air pollution.
Time Frame: Through study completion, an average of 1 year
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Short- and long- term influence of air pollution on the number of hospital admissions for acute coronary syndromes.
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Through study completion, an average of 1 year
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Number of atrial fibrillation episodes related with impact of air pollution.
Time Frame: Through study completion, an average of 1 year
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Short- and long- term influence of air pollution on the number of hospital admissions for atrial fibrillation.
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Through study completion, an average of 1 year
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Number of hospitalizations due to kidney diseases related with impact of air pollution.
Time Frame: Through study completion, an average of 1 year
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Long- term influence of air pollution on the number of hospital admissions for kidney disease.
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Through study completion, an average of 1 year
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Number of hospitalizations due to acute kidney diseases related with impact of air pollution.
Time Frame: Through study completion, an average of 1 year
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Long- term influence of air pollution on the number of hospital admissions for kidney disease.
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Through study completion, an average of 1 year
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Number of patients under hemodialysis related with impact of air pollution.
Time Frame: Through study completion, an average of 1 year
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Long- term influence of air pollution on the number of hospital admissions for kidney disease.
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Through study completion, an average of 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiovascular mortality
Time Frame: Through study completion, an average of 1 year
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Short- and long- term influence of air pollution on the number of cardiovascular mortality.
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Through study completion, an average of 1 year
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Neoplasm mortality
Time Frame: Through study completion, an average of 1 year
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Short- and long- term influence of air pollution on neoplasm mortality.
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Through study completion, an average of 1 year
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Kidney disease mortality
Time Frame: Through study completion, an average of 1 year
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Short- and long- term influence of air pollution on mortality related to renal function.
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Through study completion, an average of 1 year
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Łukasz Kuźma, Medical University of Bialystok
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Urologic Diseases
- Arrhythmias, Cardiac
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Kidney Diseases
- Atrial Fibrillation
- Acute Coronary Syndrome
Other Study ID Numbers
- UMB-KKI-104
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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