Respiratory DiseaseNCT05169463
NETTUNIT - Italy-Tunisia Cross-border Environmental network_1
An observational study of Respiratory Disease and Cardiovascular Diseases, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
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). Read more about this study
- Who is it for?
- Ages 0 to 100 years
- Conditions the study is for
- Respiratory Disease, Cardiovascular Diseases
- How many people
- 10,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2021to 3 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All emergency room visits for respiratory or cardiovascular problems at the hospital of Gela (Italy) and Niscemi (Italy), from 2010 to 2019.
Who may be able to join
- All emergency room visits for respiratory or cardiovascular problems at the hospital of Gela (Italy) and Niscemi (Italy), from 2010 to 2019.
Who cannot join
- Emergency room visits for other diseases.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Palermo, 90146
Stefania La Grutta, MD, 0916809194, stefania.lagrutt@irib.cnr.it
About this study
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.
- Conditions
- Respiratory Disease, Cardiovascular Diseases
- Medical subject headings
- Respiration Disorders, Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From year 2010 to year 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2021
- Study start1 Jun 2021
- Primary completion3 Mar 2023 (estimated)
- Study completion3 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione Biomedica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefania La Grutta, MD, Istituto per la Ricerca e l'Innovazione Biomedica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05169463
- Sponsor's protocol ID
- 03/2021_1
- Status last verified
- Dec 2021
- First submitted
- 16 Nov 2021
- Last updated
- 27 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NETTUNIT - Italy-Tunisia Cross-border Environmental network_1
- ClinicalTrials.gov ID
- NCT05169463
- Acronym / sponsor ID
- 03/2021_1
- Conditions
- Respiratory Disease, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione BiomedicaUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 3 Mar 2023 (estimated)
- Study completion
- 3 Mar 2023 (estimated)
- First posted
- 27 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All emergency room visits for respiratory or cardiovascular problems at the hospital of Gela (Italy) and Niscemi (Italy), from 2010 to 2019.
Key inclusion criteria (1 listed)
- All emergency room visits for respiratory or cardiovascular problems at the hospital of Gela (Italy) and Niscemi (Italy), from 2010 to 2019.
Key exclusion criteria (1 listed)
- Emergency room visits for other diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Disease and Cardiovascular Diseases, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefania La Grutta, MD (0916809194, stefania.lagrutta@irib.cnr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of emergency room visit for respiratory diseases (binary outcome) (time frame: From year 2010 to year 2019). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2021.