NCT05198492

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,300,000

participants targeted

Target at P75+ for all trials

Timeline
55mo left

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Jan 2011Dec 2030

Study Start

First participant enrolled

January 1, 2011

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 6, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
8.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Expected
Last Updated

June 21, 2024

Status Verified

June 1, 2024

Enrollment Period

10 years

First QC Date

January 6, 2022

Last Update Submit

June 18, 2024

Conditions

Keywords

Air PollutionPublic HealthAcute Coronary SyndromesAtrial FibrillationKidney DiseasesParticulate MatterCardiovascular Diseases

Outcome Measures

Primary Outcomes (6)

  • Number of acute coronary syndromes related to the 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

  • Number of atrial fibrillation episodes related to the 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

  • Number of hospitalizations due to kidney diseases related to the 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

  • Number of hospitalizations due to acute kidney diseases related to the 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

  • Number of patients under hemodialysis related to the 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

  • Number of ischemic strokes related to the impact of air pollution.

    Short- and long- term influence of air pollution on the number of hospital admissions for ischemic strokes.

    Through study completion, an average of 1 year

Secondary Outcomes (3)

  • Cardiovascular mortality

    Through study completion, an average of 1 year

  • Neoplasm mortality

    Through study completion, an average of 1 year

  • Kidney disease mortality

    Through study completion, an average of 1 year

Study Arms (7)

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.

Other: Impact of air pollution

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.

Other: 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.

Other: 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).

Other: Impact of air pollution

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).

Other: 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).

Other: Impact of air pollution

Patients with hospitalizations or emergency room visits due to ischemic strokes

Data on hospitalization for ischemic strokes 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.

Other: Impact of air pollution

Interventions

To assess the short- and long- term impact of air pollution

Patients who died due to cardiovascular diseasesPatients who died due to kidney diseasesPatients who died due to neoplasm diseasesPatients with hospitalizations or emergency room visits due to acute coronary syndromesPatients with hospitalizations or emergency room visits due to atrial fibrillationPatients with hospitalizations or emergency room visits due to ischemic strokesPatients with hospitalizations or emergency room visits due to kidney diseases

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Residents from the analyzed area

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Invasive Cardiology, Medical University of Bialystok

Bialystok, Podlaskie Voivodeship, 15-276, Poland

Location

Related Publications (11)

  • 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.

    PMID: 33120927BACKGROUND
  • 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.

    PMID: 32717977BACKGROUND
  • 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.

    PMID: 34075149BACKGROUND
  • 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.

    PMID: 33872649BACKGROUND
  • 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.

    PMID: 32758862BACKGROUND
  • 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.

    PMID: 31742576BACKGROUND
  • 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.

  • 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.

  • Swieczkowski M, Lip GYH, Kurasz A, Jemielita P, Duzinkiewicz M, Januszko T, Dobrzycki S, Kuzma L. Short-term exposure to air pollution and risk of ischemic stroke requiring intravenous thrombolysis: a population-level analysis in Poland from the EP-PARTICLES study. Environ Health. 2025 Sep 29;24(1):69. doi: 10.1186/s12940-025-01230-2.

  • Swieczkowski M, Lip GYH, Abohashem S, Jemielita P, Kurasz A, Duzinkiewicz M, Januszko T, Tomaszuk-Kazberuk A, Dobrzycki S, Kuzma L. Interplay between mental health, greenness, and environmental factors in cardiovascular mortality: insights from AIR-MIND. Eur J Prev Cardiol. 2025 Dec 23;32(18):1915-1927. doi: 10.1093/eurjpc/zwaf534.

  • Swieczkowski M, Lip GYH, Kurasz A, Dabrowski EJ, Tomaszuk-Kazberuk A, Kaminski JW, Struzewska J, Dobrzycki S, Kuzma L. Association between exposure to air pollution and increased ischaemic stroke incidence: a retrospective population-based cohort study (EP-PARTICLES study). Eur J Prev Cardiol. 2025 Mar 18;32(4):276-287. doi: 10.1093/eurjpc/zwae301.

MeSH Terms

Conditions

Acute Coronary SyndromeAtrial FibrillationKidney DiseasesIschemic StrokeCardiovascular Diseases

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesVascular DiseasesArrhythmias, CardiacPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesStrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Łukasz Kuźma

    Medical University of Bialystok

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 6, 2022

First Posted

January 20, 2022

Study Start

January 1, 2011

Primary Completion

December 31, 2020

Study Completion (Estimated)

December 1, 2030

Last Updated

June 21, 2024

Record last verified: 2024-06

Locations