Dyspnea; CardiacPArADIsENCT02800122
PAthwAy of Dyspneic patIent in Emergency (PArADIsE)
An observational study of Dyspnea; Cardiac and Acute Disease, run by CHOUIHED Tahar at 1 site in France.
Trial summary
This is an observational retrospective single-center study (CHRU of Nancy) in patients cared for acute dyspnea by a medical team of the emergencies of the CHRU of Nancy. The main purpose of the study is to evaluate the outcome of patients cared for acute dyspnea by a medical team of emergencies of CHRU of Nancy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea; Cardiac, Acute Disease
- How many people
- 24,000 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2016to 25 Oct 2025
- 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: Patients with acute dyspnea cared by a medical team of emergencies of CHRU Nancy in the last 5 years.
Who may be able to join
- Man or women ≥ 18 years
- Patients with acute dyspnea cared by a medical team of the emergencies of CHRU of Nancy.
Who cannot join
- Cardiorespiratory arrest before the care by a medical team of the emergencies of the CHRU of Nancy.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU Nancy - Service des Urgences
Nancy, 54000
Tahar CHOUIHED, MD, +33 3 83 85 14 96, t.chouihed@chru-nancy.fr
Tahar CHOUIHED, MD
About this study
Official title: PAthwAy of Dyspneic patIent in Emergency
This is an observational retrospective single-center study (CHRU of Nancy) in patients cared for acute dyspnea by a medical team of the emergencies of the CHRU of Nancy.
The main purpose of the study is to evaluate the outcome of patients cared for acute dyspnea by a medical team of emergencies of CHRU of Nancy.
Read the detailed description
This observational retrospective single-center study will be conducted using data from medical records, acquired as part of usual care, patients cared for acute dyspnea in the last 5 years (from the date of authorization of data processing). About 4,000 patients will be affected, including more than 800 patients with acute heart failure.
- Conditions
- Dyspnea; Cardiac, Acute Disease
- Keywords
- acute dyspnea, emergency, acute heart failure
- Medical subject headings
- Dyspnea, Acute Disease, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with acute dyspnea | Patients with acute dyspnea treated by a medical team of emergencies of CHRU of Nancy. All patients admitted to the emergencies in the last 5 years matching the inclusion criteria will be evaluated. About 4,000 patients will be affected, including more than 800 patients with acute heart failure. (Figures based on export of ICD X codes (R06.0: Dyspnea) of patients cared in extra-hospital for acute dyspnea (diagnosis Dyspnea + Heart Failure) over the last 5 years). |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause in-hospital mortality
Measured: in the last 5 years
Secondary outcomes (9)
Demographic and clinical data of patients cared by a medical team of emergencies
Measured: in the last 5 years
Duration of total hospitalization (including emergency stay and conventional hospitalization)
Measured: in the last 5 years
The main diagnosis of the initial hospitalization
Measured: in the last 5 years
Rate of Brain Natriuretic Peptide (BNP)
Measured: in the last 5 years
Administration of non-invasive ventilation and / or diuretics and / or nitrates
Measured: in the last 5 years
Administration time of non-invasive ventilation and / or diuretics and / or nitrates
Measured: in the last 5 years
Service type admitting the patient after the emergency care (intensive care, cardiology, intensive care cardiology, other ...)
Measured: in the last 5 years
Admission time in a service after the emergency care
Measured: in the last 5 years
Mortality and re-hospitalization of included patients
Measured: in the last 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2018
- Study completion25 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dyspnea; CardiacStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 24,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHOUIHED Tahar
- Sponsor type
- University, hospital or other
- Collaborators
- Central Hospital, Nancy, France
- Responsible party
- Sponsor-investigator, CHOUIHED Tahar, Central Hospital, Nancy, France
- Investigators
- Tahar CHOUIHED, MD, PhD, Principal investigator, Central Hospital, Nancy, FranceNicolas GIRERD, MD, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800122
- Sponsor's protocol ID
- R2016-08
- Acronym
- PArADIsE
- Status last verified
- Apr 2023
- First submitted
- 6 Jun 2016
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Chouihed T, Bassand A, Duarte K, Jaeger D, Roth Y, Giacomin G, Delaruelle A, Duchanois C, Bannay A, Kobayashi M, Rossignol P, Girerd N. Head-to-head comparison of diagnostic scores for acute heart failure in the emergency department: results from the PARADISE cohort. Intern Emerg Med. 2022 Jun;17(4):1155-1163. doi: 10.1007/s11739-021-02879-6. Epub 2021 Nov 17.
PubMed 34787803Chouihed T, Buessler A, Bassand A, Jaeger D, Virion JM, Nace L, Barbe F, Salignac S, Rossignol P, Zannad F, Girerd N. Hyponatraemia, hyperglycaemia and worsening renal function at first blood sample on emergency department admission as predictors of in-hospital death in patients with dyspnoea with suspected acute heart failure: retrospective observational analysis of the PARADISE cohort. BMJ Open. 2018 Mar 30;8(3):e019557. doi: 10.1136/bmjopen-2017-019557.
PubMed 29602842
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PAthwAy of Dyspneic patIent in Emergency
- ClinicalTrials.gov ID
- NCT02800122
- Acronym / sponsor ID
- PArADIsE / R2016-08
- Conditions
- Dyspnea; Cardiac, Acute Disease
- Keywords
- acute dyspnea, emergency, acute heart failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24,000 participants (estimated)
- Lead sponsor
- CHOUIHED TaharUniversity, hospital or other
- Collaborators
- Central Hospital, Nancy, France
- Study start
- Mar 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- 25 Oct 2025 (estimated)
- First posted
- 15 Jun 2016 (estimated)
- 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.
This is an observational retrospective single-center study (CHRU of Nancy) in patients cared for acute dyspnea by a medical team of the emergencies of the CHRU of Nancy.
The main purpose of the study is to evaluate the outcome of patients cared for acute dyspnea by a medical team of emergencies of CHRU of Nancy.
Detailed description
This observational retrospective single-center study will be conducted using data from medical records, acquired as part of usual care, patients cared for acute dyspnea in the last 5 years (from the date of authorization of data processing). About 4,000 patients will be affected, including more than 800 patients with acute heart failure.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with acute dyspnea | – | –Patients with acute dyspnea treated by a medical team of emergencies of CHRU of Nancy. All patients admitted to the emergencies in the last 5 years matching the inclusion criteria will be evaluated. About 4,000 patients will be affected, including more than 800 patients with acute heart failure. (Figures based on export of ICD X codes (R06.0: Dyspnea) of patients cared in extra-hospital for acute dyspnea (diagnosis Dyspnea + Heart Failure) over the last 5 years). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute dyspnea cared by a medical team of emergencies of CHRU Nancy in the last 5 years.
Key inclusion criteria (2 listed)
- Man or women ≥ 18 years
- Patients with acute dyspnea cared by a medical team of the emergencies of CHRU of Nancy.
Key exclusion criteria (1 listed)
- Cardiorespiratory arrest before the care by a medical team of the emergencies of the CHRU of Nancy.
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
All cause in-hospital mortality
Time frame: in the last 5 years
9 secondary outcomes
Demographic and clinical data of patients cared by a medical team of emergencies
Time frame: in the last 5 years
Duration of total hospitalization (including emergency stay and conventional hospitalization)
Time frame: in the last 5 years
The main diagnosis of the initial hospitalization
Time frame: in the last 5 years
Rate of Brain Natriuretic Peptide (BNP)
Time frame: in the last 5 years
Administration of non-invasive ventilation and / or diuretics and / or nitrates
Time frame: in the last 5 years
Administration time of non-invasive ventilation and / or diuretics and / or nitrates
Time frame: in the last 5 years
Service type admitting the patient after the emergency care (intensive care, cardiology, intensive care cardiology, other ...)
Time frame: in the last 5 years
Admission time in a service after the emergency care
Time frame: in the last 5 years
Mortality and re-hospitalization of included patients
Time frame: in the last 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Derived from this study: PubMed 34787803Chouihed T, Bassand A, Duarte K, Jaeger D, Roth Y, Giacomin G, Delaruelle A, Duchanois C, Bannay A, Kobayashi M, Rossignol P, Girerd N. Head-to-head comparison of diagnostic scores for acute heart failure in the emergency department: results from the PARADISE cohort. Intern Emerg Med. 2022 Jun;17(4):1155-1163. doi: 10.1007/s11739-021-02879-6. Epub 2021 Nov 17.
- Derived from this study: PubMed 29602842Chouihed T, Buessler A, Bassand A, Jaeger D, Virion JM, Nace L, Barbe F, Salignac S, Rossignol P, Zannad F, Girerd N. Hyponatraemia, hyperglycaemia and worsening renal function at first blood sample on emergency department admission as predictors of in-hospital death in patients with dyspnoea with suspected acute heart failure: retrospective observational analysis of the PARADISE cohort. BMJ Open. 2018 Mar 30;8(3):e019557. doi: 10.1136/bmjopen-2017-019557.
- 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.
Tahar CHOUIHED, MD, PhD principal investigator
Central Hospital, Nancy, France
Nicolas GIRERD, MD principal investigator
Central Hospital, Nancy, France
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 Dyspnea; Cardiac and Acute Disease, run by CHOUIHED Tahar at 1 site 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 2 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 18 Apr 2023. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tahar CHOUIHED, MD, PhD (+ 33 3 83 15 73 88, t.chouihed@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause in-hospital mortality (time frame: in the last 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02800122, which also lists 2 linked publications.
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 18 Apr 2023.