- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04417881
EVALUER L'IMPACT PREDICTIF DU SCORE MEESSI POUR LA STRATIFICATION DU RISQUE DES PATIENTS ADMIS POUR INSUFFISANCE CARDIAQUE AIGUE DANS LES STRUCTURES D'URGENCES (ICA-MEESSI)
October 1, 2021 updated by: University Hospital, Strasbourg, France
EVALUER L'IMPACT PREDICTIF DU SCORE MEESSI POUR LA STRATIFICATION DU RISQUE DES PATIENTS ADMIS POUR INSUFFISANCE CARDIAQUE AIGUE DANS LES STRUCTURES D'URGENCES (ICA-MEESSI)
Our primary purpose is to assess MEESSI score in predicting mortality and readmission of patients managed for acute heart failure (AHF) in Emergency Department.
European Society of Cardiology recommend risk stratification for patients with AHF. MEESSI score is not prospectively validated out of Spain.
Study Overview
Study Type
Observational
Enrollment (Actual)
367
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Besançon, France, 25030
- Hopital Jean Minjoz
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Cahors, France, 46005
- Centre Hospitalier Jean Rougie
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Colmar, France, 68000
- Hopitaux Civils de Colmar
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Haguenau, France, 67500
- CH Haguenau
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Montbrison, France, 42605
- Centre Hospitalier Forez
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Montpellier, France, 34295
- CHU de Montpellier
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Nancy, France, 54035
- Chu de Nancy
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Paris, France, 75013
- CHU Pitié Salpétrière
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Reims, France, 51100
- CHU de Reims
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Remiremont, France, 88200
- Ch Remiremont
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Sarreguemines, France, 57200
- Hôpital Robert Pax
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Strasbourg, France, 67091
- Les Hôpitaux Universitaires de Strasbourg
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Toulouse, France, 31300
- CHU Toulouse
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Trévenans, France, 90400
- Hôpital Nord Franche Comté
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patient admitted to emergencies with suspicion of ICA
Description
Inclusion Criteria:
- Major patient
- Patient admitted to emergencies with suspicion of ICA according to the clinical intuition of the emergency doctor after interrogation, clinical examination, biology and imaging
- Patient with health insurance
- Subject who accept to participate in the research
Exclusion Criteria:
- Patient who refuse to participate in the study
- Patient with coronary syndrome with ST segment elevation
- Other diagnosis of dyspnea
- Persons deprived of their freedom or under the protection of justice
- Persons under guardianship or curatorship
- Impossibility of giving the patient informed information
- Pregnant woman
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
patients with acurate heart failure
|
MEESSI score in predicting mortality and readmission of patients managed for acute heart failure (AHF) in Emergency Department.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MEESSI score
Time Frame: 30 days
|
Tscore to predict the patient's future in the month following management for ED ICA.
That is to say the number of days alive outside the hospital in the month following an ICA episode.
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Re-admission rate
Time Frame: 30 days
|
30-day re-admission rate compared between the 4 risk categories defined by the MEESSI score
|
30 days
|
Mortality rate
Time Frame: 30 days
|
Mortality rate at 30 days compared between the 4 risk categories defined by the MEESSI score
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30 days
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Sensitivity
Time Frame: 30 days
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Sensitivity, specificity and ROC curve of the MEESSI score in relation to the composite criterion according to the 4 risk categories
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30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 19, 2020
Primary Completion (ACTUAL)
December 19, 2020
Study Completion (ACTUAL)
June 23, 2021
Study Registration Dates
First Submitted
June 2, 2020
First Submitted That Met QC Criteria
June 2, 2020
First Posted (ACTUAL)
June 5, 2020
Study Record Updates
Last Update Posted (ACTUAL)
October 8, 2021
Last Update Submitted That Met QC Criteria
October 1, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7880
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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