Evaluate the Predictive Impact of the EHMRG | NCT05632263

Studies
Evaluate the Predictive Impact of the EHMRG

NCT05632263

Sponsor

University of Monastir

Status

Unknown status

Last Update Posted

Mar 14, 2023Actual

Enrollment

1,500Estimated

Phase

Not provided

Conditions

Emergencies
Heart Diseases

Interventions

EHMRGscore

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 30, 2023Estimated

Primary Completion Date

Nov 30, 2023Estimated

Completion Date

Dec 15, 2023Estimated

First Submitted Date

Nov 19, 2022

First Submission Date that Met QC Criteria

Nov 19, 2022

First Posted Date

Nov 30, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2023

Last Update Posted Date

Mar 14, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EHMRGscore		validation of the EHMRG score for hospitalized patients with acute heart failure in the emergency department	Diagnostic Test: EHMRGscore

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EHMRGscore	Diagnostic Test	validation of the EHMRG score for hospitalized patients with acute heart failure in the emergency department	EHMRGscore

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	7days

Secondary Outcomes

Measure	Description	Time Frame
Re-admission rate 30-day re-admission rate	30day ré-admission rate	30days
Mortality rate Mortality rate at 30 days	Mortality rate at 30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

95 Years

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nouira semir, Pr	Contact	73106046	216	semir.nouira@rns.tn
Bel Hadj Ali khaoula, MD	Contact	73106046	216	belhadjalikhaoula@yahoo.fr

Overall Officials

Name	Affiliation	Role
Nouira Semir, Pr	University of Monastir	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

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.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004630	Emergencies
D006331	Heart Diseases

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided