NETTUNIT - Italy-Tunisia Cross-border Environmental network_1

December 23, 2021 updated by: Stefania La Grutta, MD, Istituto per la Ricerca e l'Innovazione Biomedica
Retrospective, case-crossover study aiming to use environmental pollutant data for assessing the associated risk of visiting the emergency room (ER) for respiratory or cardiovascular problems in the territory of the Caltanissetta Provincial Health Authority (Italy). All the ER visits for respiratory and/or cardiovascular disorders in the hospital of Gela (Italy) and Niscemi (Italy) from 2010 to 2019 will be considered.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Palermo, Italy, 90146
        • Recruiting
        • Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All emergency room visits for respiratory or cardiovascular problems at the hospital of Gela (Italy) and Niscemi (Italy), from 2010 to 2019.

Description

Inclusion Criteria:

  • All emergency room visits for respiratory or cardiovascular problems at the hospital of Gela (Italy) and Niscemi (Italy), from 2010 to 2019.

Exclusion Criteria:

  • Emergency room visits for other diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of emergency room visit for respiratory diseases (binary outcome)
Time Frame: From year 2010 to year 2019
Dates of emergency room visits (case days) for respiratory diseases will be retrieved and linked to air pollution data. For each case day, the binary outcome will be equal to 1. For the two control days (7 days before/after the case day), the binary outcome will be equal to 0.
From year 2010 to year 2019
Occurrence of emergency room visit for cardiovascular diseases (binary outcome)
Time Frame: From year 2010 to year 2019
Dates of emergency room visits (case days) for cardiovascular diseases will be retrieved and linked to air pollution data. For each case day, the binary outcome will be equal to 1. For the two control days (7 days before/after the case day), the binary outcome will be equal to 0.
From year 2010 to year 2019

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto per la Ricerca e l'Innovazione Biomedica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Anticipated)

March 3, 2023

Study Completion (Anticipated)

March 3, 2023

Study Registration Dates

First Submitted

November 16, 2021

First Submitted That Met QC Criteria

December 23, 2021

First Posted (Actual)

December 27, 2021

Study Record Updates

Last Update Posted (Actual)

December 27, 2021

Last Update Submitted That Met QC Criteria

December 23, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03/2021_1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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