Pollution; ExposurePL-PARTICLESNCT04541498
Impact of Air Pollution and Climate Changes on the Epidemiology of Cardiovascular Disease
An observational study of Pollution; Exposure and Acute Coronary Syndrome, run by Medical University of Bialystok at 1 site in Poland.
Trial summary
Despite the fact that the topic of air pollution has been in focus of researchers for many years, there are no big studies that take up the matter of its influence on acute coronary, cerebral syndromes and CVD mortality in Europe. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pollution; Exposure, Acute Coronary Syndrome, Chronic Coronary Insufficiency
- What is being tested?
- Impact of air pollution and climate changes
- How many people
- 150,000 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2019to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: In primary we focus on Podlaskie Voivodeship. The region is located in north-east Poland which is a developing country as well as one of the poorest regions of the EU. Within four national parks, the region is widely known as the Green Lungs of Poland, mainly due to large areas covered by forests, lack of factories, and relatively low industrialization.
Who may be able to join
- residents from analysed area.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Invasive Cardiology Medical University of Białystok 24A M. Skłodowskiej-Curie St.
Bialystok, 15-276
About this study
Despite the fact that the topic of air pollution has been in focus of researchers for many years, there are no big studies that take up the matter of its influence on acute coronary, cerebral syndromes and CVD mortality in Europe. Taking into consideration the scarce number of surveys from Europe the investigators decided to analyze the impact of air pollution on cardiovascular diseases and CVD mortality in Poland.
Read the detailed description
Air quality and its impact on health was put in the spotlight since the infamous Great Smog of London. Since then, it became clear that adverse effects are serious and can no longer be ignored. According to the World Health Organization (WHO) estimations, in last year ambient air pollution caused 4,200,000 deaths worldwide. These statistics included a total of 29,165 deaths that were attributed to air pollution in Poland.
The vast of studies are conducted in highly polluted areas, in which patients are exposed to extreme concentrations like China oraz Indie. Taking into consideration the scarce number of surveys from Europe the investigators decided to analyze the impact of air pollution and cardiovascular diseases in Poland.
Data on morbidity and mortality were collected from the National Statistical Office in Poland. The data of air pollutions and gases were obtained from Voivodeship Inspectorate for Environmental Protection. The daily meteorological data were obtained from the Institute of Meteorology and Water Manageme
- Conditions
- Pollution; Exposure, Acute Coronary Syndrome, Chronic Coronary Insufficiency, Particulate Matter Inhalation Injury, Cardiovascular Diseases, Cardiovascular Risk Factor
- Being tested
- Impact of air pollution and climate changes
- Keywords
- Air pollution, Particulate Matter, Acute Coronary Syndromes, Cardiovascular Disease, Risk factors
- Medical subject headings
- Acute Coronary Syndrome, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impact of air pollution and climate changesOther
To assess the short- and long- term impact of air pollution and climate changes
| Study group | Role | What they receive |
|---|---|---|
| Population of Poland | Exposure to short term long term effects of air pollution and climate change Receives: Other: Impact of air pollution and climate changes | |
| Patients with Acute Coronary and Cerebral Syndromes | Exposure to short term long term effects of air pollution and climate change Receives: Other: Impact of air pollution and climate changes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute coronary syndromes
Number of acute coronary syndromes related with impact of air pollution
Measured: Through study completion, an average of 1 year
Incidence of cardiovascular mortality
Number of cardiovascular deaths related with impact of air pollution
Measured: Through study completion, an average of 1 year
Incidence of acute cerebral syndromes
Number of acute cerebral syndromes related with impact of air pollution
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start1 Jan 2019
- Primary completion1 Aug 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pollution; ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 150,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lukasz Kuzma, Medical University of Bialystok
- Investigators
- Lukasz Kuzma, MD, PhD, Principal investigator, Medical University of Bialystok, Department of Invasive Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04541498
- Sponsor's protocol ID
- UMB-KKI-103
- Acronym
- PL-PARTICLES
- Status last verified
- Sep 2021
- First submitted
- 21 Aug 2020
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All IPD that underlie results in a publication
Publications
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.
PubMed 31742576Kuzma 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.
PubMed 32758862Kuzma 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.
PubMed 32717977Kuzma 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.
PubMed 33872649Rogalska E, Kurasz A, Kuzma L, Bachorzewska-Gajewska H, Dobrzycki S, Kozinski M, Sobkowicz B, Tomaszuk-Kazberuk A. Comparing Atrial-Fibrillation Validated Rapid Scoring Systems in the Long-Term Mortality Prediction in Patients Referred for Elective Coronary Angiography: A Subanalysis of the Bialystok Coronary Project. Int J Environ Res Public Health. 2022 Aug 21;19(16):10419. doi: 10.3390/ijerph191610419.
PubMed 36012052
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Air Pollution and Climate Changes on the Epidemiology of Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT04541498
- Acronym / sponsor ID
- PL-PARTICLES / UMB-KKI-103
- Conditions
- Pollution; Exposure, Acute Coronary Syndrome, Chronic Coronary Insufficiency, Particulate Matter Inhalation Injury, Cardiovascular Diseases, Cardiovascular Risk Factor
- Keywords
- Air pollution, Particulate Matter, Acute Coronary Syndromes, Cardiovascular Disease, Risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150,000 participants (actual)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 9 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite the fact that the topic of air pollution has been in focus of researchers for many years, there are no big studies that take up the matter of its influence on acute coronary, cerebral syndromes and CVD mortality in Europe. Taking into consideration the scarce number of surveys from Europe the investigators decided to analyze the impact of air pollution on cardiovascular diseases and CVD mortality in Poland.
Detailed description
Air quality and its impact on health was put in the spotlight since the infamous Great Smog of London. Since then, it became clear that adverse effects are serious and can no longer be ignored. According to the World Health Organization (WHO) estimations, in last year ambient air pollution caused 4,200,000 deaths worldwide. These statistics included a total of 29,165 deaths that were attributed to air pollution in Poland.
The vast of studies are conducted in highly polluted areas, in which patients are exposed to extreme concentrations like China oraz Indie. Taking into consideration the scarce number of surveys from Europe the investigators decided to analyze the impact of air pollution and cardiovascular diseases in Poland.
Data on morbidity and mortality were collected from the National Statistical Office in Poland. The data of air pollutions and gases were obtained from Voivodeship Inspectorate for Environmental Protection. The daily meteorological data were obtained from the Institute of Meteorology and Water Manageme
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Population of Poland | – | Other: Impact of air pollution and climate changesExposure to short term long term effects of air pollution and climate change |
| Patients with Acute Coronary and Cerebral Syndromes | – | Other: Impact of air pollution and climate changesExposure to short term long term effects of air pollution and climate change |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- In primary we focus on Podlaskie Voivodeship. The region is located in north-east Poland which is a developing country as well as one of the poorest regions of the EU. Within four national parks, the region is widely known as the Green Lungs of Poland, mainly due to large areas covered by forests, lack of factories, and relatively low industrialization.
Key inclusion criteria (1 listed)
- residents from analysed area.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Impact of air pollution and climate changesTo assess the short- and long- term impact of air pollution and climate changes | Other | Patients with Acute Coronary and Cerebral Syndromes, Population of Poland |
Primary outcome
Incidence of acute coronary syndromes
Time frame: Through study completion, an average of 1 year
Number of acute coronary syndromes related with impact of air pollution
Incidence of cardiovascular mortality
Time frame: Through study completion, an average of 1 year
Number of cardiovascular deaths related with impact of air pollution
Incidence of acute cerebral syndromes
Time frame: Through study completion, an average of 1 year
Number of acute cerebral syndromes related with impact of air pollution
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
- Results publication: PubMed 31742576Kuzma 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.
- Results publication: PubMed 32758862Kuzma 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.
- Results publication: PubMed 32717977Kuzma 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.
- Results publication: PubMed 33872649Kuzma 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.
- Derived from this study: PubMed 36012052Rogalska E, Kurasz A, Kuzma L, Bachorzewska-Gajewska H, Dobrzycki S, Kozinski M, Sobkowicz B, Tomaszuk-Kazberuk A. Comparing Atrial-Fibrillation Validated Rapid Scoring Systems in the Long-Term Mortality Prediction in Patients Referred for Elective Coronary Angiography: A Subanalysis of the Bialystok Coronary Project. Int J Environ Res Public Health. 2022 Aug 21;19(16):10419. doi: 10.3390/ijerph191610419.
- Individual participant dataSharing planned: No. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lukasz Kuzma, MD, PhD principal investigator
Medical University of Bialystok, Department of Invasive Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pollution; Exposure and Acute Coronary Syndrome, run by Medical University of Bialystok at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of acute coronary syndromes (time frame: Through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04541498, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2022.