EmergenciesMEESSINCT05340972
Evaluate the Predictive Impact of the MEESSI Score
An observational study of Emergencies and Heart Diseases, run by University of Monastir at 1 site in Tunisia.
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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Emergencies, Heart Diseases
- What is being tested?
- MEESSI score
- How many people
- 1,500 participants
- Where
- 1 siteTunisia
- Study dates
- 15 Jan 2009to 30 May 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 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient admitted to emergencies with a final diagnosis of AHF
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Tunisia1 site, 1 recruiting
- Recruiting
Emergency department of University hospital Fattouma Bourguiba
Monastir, 5000
semir nouira, professor, 73106000 ext. 216, semir.nouira@rns.tn
Khaoula bel haj ali, MD, 29777277 ext. 216, belhajalikhaoula@yahoo.fr
About this study
Official title: Evaluate the Predictive Impact of the Meessi MEESSI Score for the Risk Stratification of Patients Admitted for Acute Heart Failure in Emergency Department
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.
Read the detailed 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.
- Conditions
- Emergencies, Heart Diseases
- Being tested
- MEESSI score
- Keywords
- MEESSI score, ACUTE HEART FAILURE
- Medical subject headings
- Emergencies, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEESSI scoreDiagnostic test
The score aimed to predict the AHF patient's future in the month following management for ED
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (3)
Re-admission rate [ Time Frame: 30 days ]
30-day re-admission rate compared between the 4 risk categories defined by the MEESSI score
Measured: 30 days
Mortality rate [ Time Frame: 30 days ]
Mortality rate at 30 days compared between the 4 risk categories defined by the MEESSI score
Measured: 30 days
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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start15 Jan 2009
- Primary completion30 May 2023 (estimated)
- Study completion30 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmergenciesStudies 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
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
- Investigators
- Semir Nouira, Pr, Principal investigator, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05340972
- Sponsor's protocol ID
- MEESSI 2022
- Acronym
- MEESSI
- Status last verified
- May 2023
- First submitted
- 7 Apr 2022
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: EVALUATE THE PREDICTIVE IMPACT OF THE MEESSI SCORE FOR THE RISK STRATIFICATION OF PATIENTS ADMITTED FOR ACUTE HEART FAILURE IN EMERGENCY STRUCTURES
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Predictive Impact of the Meessi MEESSI Score for the Risk Stratification of Patients Admitted for Acute Heart Failure in Emergency Department
- ClinicalTrials.gov ID
- NCT05340972
- Acronym / sponsor ID
- MEESSI / MEESSI 2022
- Conditions
- Emergencies, Heart Diseases
- Keywords
- MEESSI score, ACUTE HEART FAILURE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 15 Jan 2009 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 22 Apr 2022 (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.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient admitted to emergencies with a final diagnosis of AHF
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| MEESSI scoreThe score aimed to predict the AHF patient's future in the month following management for ED | Diagnostic test | – |
Primary outcome
MEESSI score
Time frame: 30 days
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.
3 secondary outcomes
Re-admission rate [ Time Frame: 30 days ]
Time frame: 30 days
Mortality rate [ Time Frame: 30 days ]
Time frame: 30 days
Sensitivity [ Time Frame: 30 days ]
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Individual participant dataSharing planned: No. EVALUATE THE PREDICTIVE IMPACT OF THE MEESSI SCORE FOR THE RISK STRATIFICATION OF PATIENTS ADMITTED FOR ACUTE HEART FAILURE IN EMERGENCY STRUCTURES
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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.
Semir Nouira, Pr principal investigator
University of Monastir
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 Emergencies and Heart Diseases, run by University of Monastir at 1 site in Tunisia.
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 5 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 16 May 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 Tunisia. 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 Semir Nouira, Professor (7310600 ext. 216, semir.nouira@rns.tn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MEESSI score (time frame: 30 days). 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 16 May 2023.