EHMRGscore: Evaluate the Predictive Impact of the EHMRG

• Sponsor: University of Monastir (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05632263
• Collaborator: (none)
• Enrollment: 1,500
• Anticipated Duration (Months): 5.5

Study Details

Study Description

Brief Summary

External validation of the EHMRG score for hospitalized patients with acute heart failure in the emergency department

Condition or Disease	Intervention/Treatment	Phase
Emergencies; Heart Diseases	Diagnostic Test: EHMRGscore

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

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 1500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluate the Predictive Impact of the EHMRG Score for Patients Admitted to the Emergency Department With Final Diagnosis of Acute Heart Failure
• Anticipated Study Start Date: Dec 30, 2022
• Anticipated Primary Completion Date: May 30, 2023
• Anticipated Study Completion Date: Jun 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
EHMRGscore validation of the EHMRG score for hospitalized patients with acute heart failure in the emergency department	Diagnostic Test: EHMRGscore; validation of the EHMRG score for hospitalized patients with acute heart failure in the emergency department

Outcome Measures

Primary Outcome Measures

1. EHMRGscore [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.

Secondary Outcome Measures

1. Re-admission rate 30-day re-admission rate [30days]

   30day ré-admission rate

2. Mortality rate Mortality rate at 30 days [30day]

   Mortality rate at 30 days

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 95 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients consulted for acute dyspnea and were diagnosed with acute heart failure.

• Major patient.

• Subject who accept to participate in the research.

Exclusion Criteria:

• Patient who refuse to participate in the study.

• Impossibility of giving the patient informed information

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Monastir

Investigators

• Principal Investigator: Nouira Semir, Pr, University of Monastir

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pr. Semir Nouira, clinical proffesor, University of Monastir
• ClinicalTrials.gov Identifier: NCT05632263
• Other Study ID Numbers: EHMRG_MIR
• First Posted: Nov 30, 2022
• Last Update Posted: Nov 30, 2022
• Last Verified: Nov 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Pr. Semir Nouira, clinical proffesor, University of Monastir: EHMRGscore; ACUTE HEART FAILURE
• Additional relevant MeSH terms: Heart Diseases; Emergencies

Study Results

No Results Posted as of Nov 30, 2022