NCT04539925

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9,046

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2019

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 7, 2020

Completed
Last Updated

September 7, 2020

Status Verified

August 1, 2020

Enrollment Period

7 months

First QC Date

August 31, 2020

Last Update Submit

August 31, 2020

Conditions

Keywords

Acute Coronary SyndromeAir pollution

Outcome Measures

Primary Outcomes (2)

  • Non-ST segment elevation myocardial infarction

    7 days

  • ST-segment elevation myocardial infarction

    7 days

Study Arms (2)

Industrial area

Other: Acute coronary syndrome

Non-industrial area

Other: Acute coronary syndrome

Interventions

The effect of air pollution on acute coronary syndrome

Industrial areaNon-industrial area

Eligibility Criteria

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Department of Invasive Cardiology, Medical University of Bialystok, The Medical University of Bialystok Clinical Hospital

Bialystok, Poland

Location

Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland

Katowice, 40-635, Poland

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

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

Study Record Dates

First Submitted

August 31, 2020

First Posted

September 7, 2020

Study Start

December 1, 2019

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

September 7, 2020

Record last verified: 2020-08

Locations