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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05340972
Other study ID # MEESSI 2022
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 15, 2009
Est. completion date May 30, 2023

Study information

Verified date May 2023
Source University of Monastir
Contact Semir Nouira, Professor
Phone 7310600
Email semir.nouira@rns.tn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

Improved risk stratification of acute heart failure (AHF) in the emergency department (ED) may help physicians' decisions regarding patient admission or early discharge disposition. The MEESSI-AHF (Multiple Estimation of risk based on the Emergency department Spanish Score In patients with AHF) score was developed to predict 30-day mortality in patients presenting with AHF EDs in Spain. Whether it performs well in other countries is unknown. The MEESSI-AHF risk model includes 13 variables readily available on arrival to Emergency Department. The 40% of patients classified as LOW RISK (30-day mortality: <2%) should be considered as potential candidates to be early discharged from Emergency Department without admission after adequate response to initial treatment. The 10% of patients classified as VERY HIGH RISK (30-day mortality: >2%) may clearly benefit from hospital admission. Objective: To externally validate the MEESSI-AHF score in another country.


Recruitment information / eligibility

Status Recruiting
Enrollment 1500
Est. completion date May 30, 2023
Est. primary completion date May 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 95 Years
Eligibility Inclusion Criteria: - Major patient - Patient admitted to emergencies with final diagnosis of AHF according to the opinion of two emergency experts after consulting the data from the clinical examination, cardiac echocardiography, and BNP level. - 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 causes of dyspnea - Impossibility of giving the patient informed information - Pregnant woman

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
MEESSI score
The score aimed to predict the AHF patient's future in the month following management for ED

Locations

Country Name City State
Tunisia Emergency department of University hospital Fattouma Bourguiba Monastir

Sponsors (1)

Lead Sponsor Collaborator
University of Monastir

Country where clinical trial is conducted

Tunisia, 

Outcome

Type Measure Description Time frame Safety issue
Primary MEESSI score predict the AHF patient's future in the month following management in ED with The MEESSI (Multiple Estimation of risk based on the Emergency department Spanish Score In patients with AHF).The MEESSI-AHF risk model includes 13 variables readily available on arrival to Emergency Department. The 40% of patients classified as LOW RISK (30-day mortality: <2%) should be considered as potential candidates to be early discharged from Emergency Department without admission after adequate response to initial treatment. The 10% of patients classified as VERY HIGH RISK (30-day mortality: >2%) may clearly benefit from hospital admission. 30 days
Secondary 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
Secondary Mortality rate [ Time Frame: 30 days ] Mortality rate at 30 days compared between the 4 risk categories defined by the MEESSI score 30 days
Secondary Sensitivity [ Time Frame: 30 days ] Sensitivity, specificity and ROC curve of the MEESSI score in relation to the composite criterion according to the 4 risk categories 30 days
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