Chest X-ray in Diagnosis of Heart Failure | NCT05135338

Studies
Chest X-ray in Diagnosis of Heart Failure

NCT05135338

Sponsor

University of Monastir

Status

Completed

Last Update Posted

Nov 26, 2021Actual

Enrollment

1,000Actual

Phase

Not provided

Conditions

Chest X-ray ; Heart Failure

Interventions

Not provided

Countries

Tunisia

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

Nov 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 21, 2018Actual

Primary Completion Date

Dec 21, 2020Actual

Completion Date

Dec 21, 2020Actual

First Submitted Date

Nov 18, 2021

First Submission Date that Met QC Criteria

Nov 18, 2021

First Posted Date

Nov 26, 2021Actual

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

Nov 18, 2021

Last Update Posted Date

Nov 26, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Pr. Semir Nouira, chief of the Emergency departement in CHU fattouma Bourguiba Monastir , PhD, University of MonastirPrincipal Investigator

Lead Sponsor

University of MonastirOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

The objective of this study is to compare the performance of x-chest ray in the diagnosis of acute cardiac insuficiency through the interpretation of a senior and a non-senior.

Detailed Description

Acute cardiac insufficiency (ICA) is a leading cause of acute dyspnea in the emergency department (SU) and is associated with a higher risk of morbidity and mortality.

An increasing number of tools for better ICA diagnosis are available in the SUs. However, there is likely room to improve the ICA diagnostic approach using widely available routine tools, including chest x-ray .

Chest x-ray is a rapid and inexpensive method that is routinely performed in an emergency in patients with acute dyspnea. This is the first-line diagnostic imaging modality recommended in the guidelines.

The objective of this study is to compare the performance of x-chest ray in the diagnosis of acute cardiac insuficiency through the interpretation of a senior and a non-senior.

A senior emergency physician or resident and an intern, perform a reading of chest x-ray in any included patient by answering to following questions:

Is there cardiomegaly? Calculation of the cardio-thoracic index Is there a vascular distribution towards the vertices, if so is it uni or bilateral? Is there pleurisy, if so is it uni or bilateral? Is there an interstitial syndrome, if so is it uni or bilateral? Is there an alveolar syndrome, if so if so is it single or bilateral? Is the diagnosis of heart failure very likely, likely or unlikely? Then there will be a comparison of the two answers.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
answer 1		a senior emergency physician on interpretation of chest x-ray and blinded to the final diagnosis .
answer 2		a resident or an intern interpretation of chest x-ray and blinded to the final diagnosis

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The reproductibility of chest x-ray in the diagnosis of heart failure	Comparison of the two answers of a senior and non -senior emergency physician chest x- ray interpretation in the probability of heart failure diagnosis .	0 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age over 18 All dyspnea acute non-traumatic A resident or intern in medicine and a senior are available to read chest x-ray within 24 hours of admission

Exclusion Criteria:

Age under 18
Post traumatic dyspnea
Patient not requiring hospitalization
Mechanical ventilation from the start
Cardio-respiratory arrest
Pregnant woman
And any patient who cannot achieve reproducibility within 24 hours of admission.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

alla patients admitted to th ED with acurte dyspnea who have recieved chest x- ray .

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fattouma Bourguiba Monastir University Hospital Center		Monastir		5000	Tunisia

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure
D004194	Disease

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided