AngioplastyACIRA-REHOSPNCT03115723
Analysis of Hospitalizations One Year After Acts of CAG and PCI in the Aquitaine région - ACIRA Register Data Analysis
An observational study of Angioplasty and Coronary Angiography, run by University Hospital, Bordeaux at 11 sites in France.
Trial summary
Hospital readmission rate following percutaneous coronary interventions (PCI) or coronary angiographies (CAG) is a main indicator of quality of care and addresses economic issues. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angioplasty, Coronary Angiography
- What is being tested?
- Percutaneous coronary intervention and Coronary angiography
- Type of treatment
- Surgery or procedure
- How many people
- 11,487 participants
- Where
- 11 sitesFrance
- Study dates
- 15 Jan 2016to 15 Jan 2017
- How long will I take part?
- 1 Year
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All volunteer adults (≥ 18 years) and French resident patients who underwent PCI and CAG in nine interventional cardiology hospitals in the Aquitaine region (France), from January 1, 2012 to December 31, 2013.
Who may be able to join
- Patients included in ACIRA Registry : All volunteer adults (≥ 18 years) and French resident patients who underwent PCI and CAG in the interventional cardiology hospitals in the Aquitaine region (France),
- Initial PCI or CAG performed from January 1, 2012 to December 31, 2013,
- Initial PCI or CAG performed in nine interventional cardiology hospitals in the Aquitaine region (France).
Who cannot join
- Patients who declined to take part of ACIRA Registry,
- Patients resident outside the Aquitaine region (France),
- Patients who died during the initial hospital stay,
- Patients hospitalized for a PCI or a CAG the month preceding the initial procedure including in the ACIRA-Rehosp study.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Clinique Esquirol St Hilaire
Agen
Clinique cardiologique d'Aressy
Aressy
GCS Bayonne
Bayonne
Clinique de Caudéran les pins-francs
Bordeaux
Clinique de St Augustin
Bordeaux
CH de Libourne
Libourne
CH de Mont de Marsan
Mont-de-Marsan
CH de Pau
Pau
CH de Perigueux
Périgueux
CHU de Bordeaux
Pessac, 33604
Hôpital privé St Martin
Pessac
About this study
Official title: Frequency and Characteristics of Rehospitalizations During One Year After Percutaneous Coronary Intervention and Coronary Angiography - Results of the ACIRA Registry, Aquitaine Region
Hospital readmission rate following percutaneous coronary interventions (PCI) or coronary angiographies (CAG) is a main indicator of quality of care and addresses economic issues. The aim of this study is to quantify the frequency and analyse the types of rehospitalizations and repeat revascularizations during one year after a PCI or a CAG. This information is needed to organize the health care pathway and to identify preventable rehospitalizations.
- Conditions
- Angioplasty, Coronary Angiography
- Being tested
- Percutaneous coronary intervention, Coronary angiography
- Keywords
- Hospitalization, Health Care Economics and Organizations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary interventionProcedure or surgery
Coronary angiographyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Group 1 : Percutaneous coronary intervention | All the patients who underwent percutaneous coronary intervention, in 9 invasive cardiology centers in the Aquitaine Region, France. Receives: Procedure: Percutaneous coronary intervention | |
| Group 2 : Coronary angiography | All the patients who underwent coronary angiography, in 9 invasive cardiology centers in the Aquitaine Region, France Receives: Procedure: Coronary angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type of rehospitalization
Measured: Baseline to 1 year
Number of rehospitalization
Measured: Baseline to 1 year
Secondary outcomes (3)
Identification of hospitals
All hospitals concerned by initial coverage and rehospitalization
Measured: Baseline to 1 year
Type of diagnoses and procedures associated with each type of rehospitalization
Measured: Baseline to 1 year
Type of cardiac rehabilitation procedures in hospitalizations for post-operative and rehabilitation wards
Measured: Baseline to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start15 Jan 2016
- Primary completion15 Jan 2017
- Study completion15 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AngioplastyStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11,487 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saillour-Glénisson Florence, MD, Study chair, University Hospital, BordeauxLesaine Emilie, MD, Study director, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03115723
- Sponsor's protocol ID
- CHUBX 2014/29
- Acronym
- ACIRA-REHOSP
- Status last verified
- Feb 2022
- First submitted
- 10 Apr 2017
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency and Characteristics of Rehospitalizations During One Year After Percutaneous Coronary Intervention and Coronary Angiography - Results of the ACIRA Registry, Aquitaine Region
- ClinicalTrials.gov ID
- NCT03115723
- Acronym / sponsor ID
- ACIRA-REHOSP / CHUBX 2014/29
- Conditions
- Angioplasty, Coronary Angiography
- Keywords
- Hospitalization, Health Care Economics and Organizations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,487 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 15 Jan 2016 (actual)
- Primary completion
- 15 Jan 2017 (actual)
- Study completion
- 15 Jan 2017 (actual)
- First posted
- 14 Apr 2017 (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.
Hospital readmission rate following percutaneous coronary interventions (PCI) or coronary angiographies (CAG) is a main indicator of quality of care and addresses economic issues. The aim of this study is to quantify the frequency and analyse the types of rehospitalizations and repeat revascularizations during one year after a PCI or a CAG. This information is needed to organize the health care pathway and to identify preventable rehospitalizations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 : Percutaneous coronary intervention | – | Procedure: Percutaneous coronary interventionAll the patients who underwent percutaneous coronary intervention, in 9 invasive cardiology centers in the Aquitaine Region, France. |
| Group 2 : Coronary angiography | – | Procedure: Coronary angiographyAll the patients who underwent coronary angiography, in 9 invasive cardiology centers in the Aquitaine Region, France |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All volunteer adults (≥ 18 years) and French resident patients who underwent PCI and CAG in nine interventional cardiology hospitals in the Aquitaine region (France), from January 1, 2012 to December 31, 2013.
Key inclusion criteria (3 listed)
- Patients included in ACIRA Registry : All volunteer adults (≥ 18 years) and French resident patients who underwent PCI and CAG in the interventional cardiology hospitals in the Aquitaine region (France),
- Initial PCI or CAG performed from January 1, 2012 to December 31, 2013,
- Initial PCI or CAG performed in nine interventional cardiology hospitals in the Aquitaine region (France).
Key exclusion criteria (4 listed)
- Patients who declined to take part of ACIRA Registry,
- Patients resident outside the Aquitaine region (France),
- Patients who died during the initial hospital stay,
- Patients hospitalized for a PCI or a CAG the month preceding the initial procedure including in the ACIRA-Rehosp study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous coronary intervention | Procedure or surgery | Group 1 : Percutaneous coronary intervention |
| Coronary angiography | Procedure or surgery | Group 2 : Coronary angiography |
Primary outcome
Type of rehospitalization
Time frame: Baseline to 1 year
Number of rehospitalization
Time frame: Baseline to 1 year
3 secondary outcomes
Identification of hospitals
Time frame: Baseline to 1 year
Type of diagnoses and procedures associated with each type of rehospitalization
Time frame: Baseline to 1 year
Type of cardiac rehabilitation procedures in hospitalizations for post-operative and rehabilitation wards
Time frame: Baseline to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Saillour-Glénisson Florence, MD study chair
University Hospital, Bordeaux
Lesaine Emilie, MD study director
University Hospital, Bordeaux
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angioplasty and Coronary Angiography, run by University Hospital, Bordeaux at 11 sites in France.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type of rehospitalization (time frame: Baseline to 1 year). 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 9 Feb 2022.