Chest X-ray ; Heart FailureNCT05135338
Chest X-ray in Diagnosis of Heart Failure
An observational study of Chest X-ray ; Heart Failure, run by University of Monastir at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Chest X-ray ; Heart Failure
- How many people
- 1,000 participants
- Where
- 1 siteTunisia
- Study dates
- 21 Jan 2018to 21 Dec 2020
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: alla patients admitted to th ED with acurte dyspnea who have recieved chest x- ray .
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Fattouma Bourguiba Monastir University Hospital Center
Monastir, 5000
About this study
Official title: Comparison Between a Senior and a Junior Interpretation of a Chest X-ray in the Diagnosis of Heart Failure
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.
Read the 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.
- Conditions
- Chest X-ray ; Heart Failure
- Keywords
- chest x-ray, heart failure, diagnosis, senior, non-senior
- Medical subject headings
- Heart Failure, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 0 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start21 Jan 2018
- Primary completion21 Dec 2020
- Study completion21 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest X-ray ; Heart FailureStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
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, PhD, Principal investigator, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135338
- Sponsor's protocol ID
- Chest-X-ray/HF
- Status last verified
- Nov 2021
- First submitted
- 18 Nov 2021
- Last updated
- 26 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between a Senior and a Junior Interpretation of a Chest X-ray in the Diagnosis of Heart Failure
- ClinicalTrials.gov ID
- NCT05135338
- Acronym / sponsor ID
- Chest-X-ray/HF
- Conditions
- Chest X-ray ; Heart Failure
- Keywords
- chest x-ray, heart failure, diagnosis, senior, non-senior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 21 Jan 2018 (actual)
- Primary completion
- 21 Dec 2020 (actual)
- Study completion
- 21 Dec 2020 (actual)
- First posted
- 26 Nov 2021 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- alla patients admitted to th ED with acurte dyspnea who have recieved chest x- ray .
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (7 listed)
- Age under 18
- Post traumatic dyspnea
- Patient not requiring hospitalization
- Mechanical ventilation from the start
- Cardio-respiratory arrest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The reproductibility of chest x-ray in the diagnosis of heart failure
Time frame: 0 days
Comparison of the two answers of a senior and non -senior emergency physician chest x- ray interpretation in the probability of heart failure diagnosis .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Chest X-ray ; Heart Failure
Recruiting
Strategy for EArly Recognition of Cancer, COPD & Heart Failure in the Emergency Department
Cancer, Cardiovascular
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, PhD 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 Chest X-ray ; Heart Failure, 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 1 inclusion and 7 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: finished, as of the sponsor's last update on 26 Nov 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The reproductibility of chest x-ray in the diagnosis of heart failure (time frame: 0 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 26 Nov 2021.