EmergenciesEHMRGscoreNCT05632263
Evaluate the Predictive Impact of the EHMRG
An observational study of Emergencies and Heart Diseases, run by University of Monastir.
Trial summary
External validation of the EHMRG score for hospitalized patients with acute heart failure in the emergency department 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?
- EHMRGscore
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2023to 15 Dec 2023
- How long will I take part?
- 6 Years
- 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: It is a prospective cohort study carried out in the ED of Monastir over a period from February 2009 to September 2020 which included patients admitted to the ED with a discharge diagnosis of AHF.
Who may be able to join
- Patients consulted for acute dyspnea and were diagnosed with acute heart failure.
- Major patient.
- Subject who accept to participate in the research.
Who cannot join
- Patient who refuse to participate in the study.
- Impossibility of giving the patient informed information
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluate the Predictive Impact of the EHMRG Score for Patients Admitted to the Emergency Department With Final Diagnosis of Acute Heart Failure
External validation of the EHMRG score for hospitalized patients with acute heart failure in the emergency department
Read the detailed description
It is a prospective cohort study carried out in the ED of Monastir which included patients admitted to the ED with a discharge diagnosis of AHF.
- Conditions
- Emergencies, Heart Diseases
- Being tested
- EHMRGscore
- Keywords
- EHMRGscore, 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.
EHMRGscoreDiagnostic test
validation of the EHMRG score for hospitalized patients with acute heart failure in the emergency department
| Study group | Role | What they receive |
|---|---|---|
| EHMRGscore | validation of the EHMRG score for hospitalized patients with acute heart failure in the emergency department Receives: Diagnostic Test: EHMRGscore |
What is being measured
The primary outcome is the main question the study is designed to answer.
EHMRGscore
The primary outcome of interest is the EHMRG predictive accuracy to prognosticate 7-day mortality was measured by the athe area under the receiver operating characteristic curver (AUROC) with 95% confidence intervals.
Measured: 7days
Secondary outcomes (2)
Re-admission rate 30-day re-admission rate
30day ré-admission rate
Measured: 30days
Mortality rate Mortality rate at 30 days
Mortality rate at 30 days
Measured: 30day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start30 Apr 2023 (estimated)
- Primary completion30 Nov 2023 (estimated)
- Study completion15 Dec 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)
- Target duration
- 6 Years
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
- Nouira Semir, Pr, Principal investigator, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632263
- Sponsor's protocol ID
- EHMRG_MIR
- Acronym
- EHMRGscore
- Status last verified
- Mar 2023
- First submitted
- 19 Nov 2022
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The EHMRG Risk score is based on commonly available parameters at presentation. It includes 10 predictors of mortality: age/mode of ED presentation / SBP / heart-rate / oxygen saturation/potassium concentration, creatinine concentration, troponin, presence of active cancer, and treatment with metolazone.
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Predictive Impact of the EHMRG Score for Patients Admitted to the Emergency Department With Final Diagnosis of Acute Heart Failure
- ClinicalTrials.gov ID
- NCT05632263
- Acronym / sponsor ID
- EHMRGscore / EHMRG_MIR
- Conditions
- Emergencies, Heart Diseases
- Keywords
- EHMRGscore, 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
- 30 Apr 2023 (estimated)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 30 Nov 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.
External validation of the EHMRG score for hospitalized patients with acute heart failure in the emergency department
Detailed description
It is a prospective cohort study carried out in the ED of Monastir which included patients admitted to the ED with a discharge diagnosis of AHF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EHMRGscore | – | Diagnostic Test: EHMRGscorevalidation of the EHMRG score for hospitalized patients with acute heart failure in the emergency department |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It is a prospective cohort study carried out in the ED of Monastir over a period from February 2009 to September 2020 which included patients admitted to the ED with a discharge diagnosis of AHF.
Key inclusion criteria (3 listed)
- Patients consulted for acute dyspnea and were diagnosed with acute heart failure.
- Major patient.
- Subject who accept to participate in the research.
Key exclusion criteria (2 listed)
- Patient who refuse to participate in the study.
- Impossibility of giving the patient informed information
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 |
|---|---|---|
| EHMRGscorevalidation of the EHMRG score for hospitalized patients with acute heart failure in the emergency department | Diagnostic test | EHMRGscore |
Primary outcome
EHMRGscore
Time frame: 7days
The primary outcome of interest is the EHMRG predictive accuracy to prognosticate 7-day mortality was measured by the athe area under the receiver operating characteristic curver (AUROC) with 95% confidence intervals.
2 secondary outcomes
Re-admission rate 30-day re-admission rate
Time frame: 30days
Mortality rate Mortality rate at 30 days
Time frame: 30day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Individual participant dataSharing planned: No. The EHMRG Risk score is based on commonly available parameters at presentation. It includes 10 predictors of mortality: age/mode of ED presentation / SBP / heart-rate / oxygen saturation/potassium concentration, creatinine concentration, troponin, presence of active cancer, and treatment with metolazone.
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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.
Nouira Semir, Pr principal investigator
University of Monastir
Questions about this trial
What is this clinical trial studying?
An observational study of Emergencies and Heart Diseases, run by University of Monastir.
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 2 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 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Nouira semir, Pr (73106046 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?
EHMRGscore (time frame: 7days). 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 14 Mar 2023; AzTrials last refreshed its copy on 31 Oct 2026.