NCT04541498

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 1, 2019

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 9, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

January 10, 2022

Status Verified

September 1, 2021

Enrollment Period

2.6 years

First QC Date

August 21, 2020

Last Update Submit

January 6, 2022

Conditions

Keywords

Air pollutionParticulate MatterAcute Coronary SyndromesCardiovascular DiseaseRisk factors

Outcome Measures

Primary Outcomes (3)

  • Incidence of acute coronary syndromes

    Number of acute coronary syndromes related with impact of air pollution

    Through study completion, an average of 1 year

  • Incidence of cardiovascular mortality

    Number of cardiovascular deaths related with impact of air pollution

    Through study completion, an average of 1 year

  • Incidence of acute cerebral syndromes

    Number of acute cerebral syndromes related with impact of air pollution

    Through study completion, an average of 1 year

Study Arms (2)

Population of Poland

Exposure to short term long term effects of air pollution and climate change

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

Other: Impact of air pollution and climate changes

Interventions

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

Patients with Acute Coronary and Cerebral SyndromesPopulation of Poland

Eligibility Criteria

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

You may qualify if:

  • \- residents from analysed 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 Białystok 24A M. Skłodowskiej-Curie St.

Bialystok, 15-276, Poland

Location

Related Publications (5)

  • 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.

  • 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, 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, 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.

  • Rogalska 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.

MeSH Terms

Conditions

Acute Coronary SyndromeCardiovascular Diseases

Interventions

Climate Change

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Climatic ProcessesEcological and Environmental PhenomenaBiological Phenomena

Study Officials

  • Lukasz Kuzma, MD, PhD

    Medical University of Bialystok, Department of Invasive Cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

August 21, 2020

First Posted

September 9, 2020

Study Start

January 1, 2019

Primary Completion

August 1, 2021

Study Completion

January 1, 2022

Last Updated

January 10, 2022

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

All IPD that underlie results in a publication

Locations