NCT05169463

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 27, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2023

Completed
Last Updated

December 27, 2021

Status Verified

December 1, 2021

Enrollment Period

1.8 years

First QC Date

November 16, 2021

Last Update Submit

December 23, 2021

Conditions

Respiratory DiseaseCardiovascular Diseases

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Eligibility Criteria

Age0 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • Emergency room visits for other diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)

Palermo, 90146, Italy

RECRUITING

MeSH Terms

Conditions

Respiration DisordersCardiovascular Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Central Study Contacts

Stefania La Grutta, MD

CONTACT

0916809194stefania.lagrutta@irib.cnr.it

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Director

Study Record Dates

First Submitted

November 16, 2021

First Posted

December 27, 2021

Study Start

June 1, 2021

Primary Completion

March 3, 2023

Study Completion

March 3, 2023

Last Updated

December 27, 2021

Record last verified: 2021-12

Locations

IT(1)