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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05169463
Other study ID # 03/2021_1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2021
Est. completion date March 3, 2023

Study information

Verified date December 2021
Source Istituto per la Ricerca e l'Innovazione Biomedica
Contact Stefania La Grutta, MD
Phone 0916809194
Email stefania.lagrutta@irib.cnr.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10000
Est. completion date March 3, 2023
Est. primary completion date March 3, 2023
Accepts healthy volunteers No
Gender All
Age group N/A to 100 Years
Eligibility 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 Design


Locations

Country Name City State
Italy Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR) Palermo

Sponsors (1)

Lead Sponsor Collaborator
Istituto per la Ricerca e l'Innovazione Biomedica

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Occurrence of emergency room visit for respiratory diseases (binary outcome) 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
Primary Occurrence of emergency room visit for cardiovascular diseases (binary outcome) 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
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