Air Pollution Exposure on Acute Coronary Syndrome in Two... | NCT04539925

Studies
Air Pollution Exposure on Acute Coronary Syndrome in Two Cohorts of Industrial and Non-industrial Areas

NCT04539925

Sponsor

Medical University of Silesia

Status

Completed

Last Update Posted

Sep 7, 2020Actual

Enrollment

9,046Actual

Phase

Not provided

Conditions

Acute Coronary Syndrome
Air Pollution

Interventions

Acute coronary syndrome

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2019Actual

Primary Completion Date

Jul 1, 2020Actual

Completion Date

Jul 1, 2020Actual

First Submitted Date

Aug 31, 2020

First Submission Date that Met QC Criteria

Aug 31, 2020

First Posted Date

Sep 7, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2020

Last Update Posted Date

Sep 7, 2020Actual

Name	Class
Medical University of Bialystok	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

9,046Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Industrial area			Other: Acute coronary syndrome
Non-industrial area			Other: Acute coronary syndrome

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acute coronary syndrome	Other	The effect of air pollution on acute coronary syndrome	Industrial area Non-industrial area

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Non-ST segment elevation myocardial infarction		7 days
ST-segment elevation myocardial infarction		7 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

The study covered all residents from industrial (Katowice) and non-industrial (Białystok) areas.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Invasive Cardiology, Medical University of Bialystok, The Medical University of Bialystok Clinical Hospital		Bialystok			Poland

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D054058	Acute Coronary Syndrome

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided