Acute Coronary SyndromeNCT04539925
Air Pollution Exposure on Acute Coronary Syndrome in Two Cohorts of Industrial and Non-industrial Areas
An observational study of Acute Coronary Syndrome and Air Pollution, run by Medical University of Silesia at 2 sites in Poland.
Trial summary
Background: There is a lack of data on the effect of air pollution on acute coronary syndrome (ACS) in industrial and non-industrial areas. Objectives: A comparison of association of air pollution exposure with ACS in two cohorts of industrially different areas. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Coronary Syndrome, Air Pollution
- What is being tested?
- Acute coronary syndrome
- How many people
- 9,046 participants
- Where
- 2 sitesPoland
- Study dates
- 1 Dec 2019to 1 Jul 2020
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study is performed in two big provincial cities in Poland, Europe, namely Bialystok and Katowice. In the last year of the analysis, the areas were inhabited by 294,925 and 296,262 residents, respectively.
The study covered all residents from industrial (Katowice) and non-industrial (Białystok) areas.
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Department of Invasive Cardiology, Medical University of Bialystok, The Medical University of Bialystok Clinical Hospital
Bialystok
Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland
Katowice, 40-635
About this study
Official title: 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)
Background: There is a lack of data on the effect of air pollution on acute coronary syndrome (ACS) in industrial and non-industrial areas.
Objectives: A comparison of association of air pollution exposure with ACS in two cohorts of industrially different areas.
Materials and methods: The study covered 6,000,000 person-years of follow-up and five types of air pollution between 2008 and 2017. A time series regression analysis with 7-lag was used to assess the effects air pollution on ACS.
- Conditions
- Acute Coronary Syndrome, Air Pollution
- Being tested
- Acute coronary syndrome
- Keywords
- Acute Coronary Syndrome, Air pollution
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute coronary syndromeOther
The effect of air pollution on acute coronary syndrome
| Study group | Role | What they receive |
|---|---|---|
| Industrial area | Not described Receives: Other: Acute coronary syndrome | |
| Non-industrial area | Not described Receives: Other: Acute coronary syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-ST segment elevation myocardial infarction
Measured: 7 days
ST-segment elevation myocardial infarction
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start1 Dec 2019
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 9,046 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Bialystok
- Responsible party
- Principal investigator, Wojciech Wańha, Medical University of Silesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04539925
- Sponsor's protocol ID
- 03
- Status last verified
- Aug 2020
- First submitted
- 31 Aug 2020
- Last updated
- 7 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04539925
- Acronym / sponsor ID
- 03
- Conditions
- Acute Coronary Syndrome, Air Pollution
- Keywords
- Acute Coronary Syndrome, Air pollution
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,046 participants (actual)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Collaborators
- Medical University of Bialystok
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 7 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.
Background: There is a lack of data on the effect of air pollution on acute coronary syndrome (ACS) in industrial and non-industrial areas.
Objectives: A comparison of association of air pollution exposure with ACS in two cohorts of industrially different areas.
Materials and methods: The study covered 6,000,000 person-years of follow-up and five types of air pollution between 2008 and 2017. A time series regression analysis with 7-lag was used to assess the effects air pollution on ACS.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Industrial area | – | Other: Acute coronary syndrome |
| Non-industrial area | – | Other: Acute coronary syndrome |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study is performed in two big provincial cities in Poland, Europe, namely Bialystok and Katowice. In the last year of the analysis, the areas were inhabited by 294,925 and 296,262 residents, respectively.
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 |
|---|---|---|
| Acute coronary syndromeThe effect of air pollution on acute coronary syndrome | Other | Industrial area, Non-industrial area |
Primary outcome
Non-ST segment elevation myocardial infarction
Time frame: 7 days
ST-segment elevation myocardial infarction
Time frame: 7 days
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 7 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and Air Pollution, run by Medical University of Silesia at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Non-ST segment elevation myocardial infarction (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Sep 2020.