Chest X-ray for Clinical EvaluationAI-CXRNCT04996381
Feasibility of AI-based Heart Function Prediction Model Using CXR
An observational study of Chest X-ray for Clinical Evaluation, run by Yonsei University at 1 site in South Korea.
Trial summary
The investigators will develop an artificial intelligence model to predict left ventricular ejection fraction using chest radiographic images and transthoracic echocardiography data. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Chest X-ray for Clinical Evaluation
- What is being tested?
- Scanning Chest X-rays and performing AI algorithms on images
- How many people
- 505 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2022to 1 Sep 2022
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing a transthoracic echocardiogram will be enrolled.
Who may be able to join
- Adults who are 20 years and older
- Patient who visited the emergency room or outpatient clinic due to dyspnea and chest pain
Who cannot join
- Patient refusal
- Uncertain radiographs or transthoracic echocardiography
- Uncertain tests results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Artificial Intelligence-based Heart Function Prediction Model Using Chest Radiography
The investigators will develop an artificial intelligence model to predict left ventricular ejection fraction using chest radiographic images and transthoracic echocardiography data.
Read the detailed description
Echocardiography should be considered at an early stage in patients who have first developed heart failure or who do not have information about heart function, but the examination may be delayed due to lack of time and manpower in the actual medical field.
Primary Objective: Use chest radiographs to predict the left ventricular ejection fraction
- Conditions
- Chest X-ray for Clinical Evaluation
- Being tested
- Scanning Chest X-rays and performing AI algorithms on images
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scanning Chest X-rays and performing AI algorithms on imagesDiagnostic test
Chest X-Rays; AI CNNs; Results
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Ejection Fraction < 40%
Evaluate the performance of chest X-ray based artificial intelligence algorithms to identify individuals with reduced ejection fraction (<40%)
Measured: Within two weeks of chest X-ray
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start1 Mar 2022
- Primary completion30 Jun 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest X-ray for Clinical EvaluationStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- 505 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SungA Bae, Yonsei University
- Investigators
- In Hyun Jung, MD, PhD, Study chair, Yongin Severance Hospital, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996381
- Sponsor's protocol ID
- YonseiU
- Acronym
- AI-CXR
- Status last verified
- Sep 2022
- First submitted
- 4 Aug 2021
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Artificial Intelligence-based Heart Function Prediction Model Using Chest Radiography
- ClinicalTrials.gov ID
- NCT04996381
- Acronym / sponsor ID
- AI-CXR / YonseiU
- Conditions
- Chest X-ray for Clinical Evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 505 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 9 Aug 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 investigators will develop an artificial intelligence model to predict left ventricular ejection fraction using chest radiographic images and transthoracic echocardiography data.
Detailed description
Echocardiography should be considered at an early stage in patients who have first developed heart failure or who do not have information about heart function, but the examination may be delayed due to lack of time and manpower in the actual medical field.
Primary Objective: Use chest radiographs to predict the left ventricular ejection fraction
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing a transthoracic echocardiogram will be enrolled.
Key inclusion criteria (2 listed)
- Adults who are 20 years and older
- Patient who visited the emergency room or outpatient clinic due to dyspnea and chest pain
Key exclusion criteria (3 listed)
- Patient refusal
- Uncertain radiographs or transthoracic echocardiography
- Uncertain tests results
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 |
|---|---|---|
| Scanning Chest X-rays and performing AI algorithms on imagesChest X-Rays; AI CNNs; Results | Diagnostic test | – |
Primary outcome
Left Ventricular Ejection Fraction < 40%
Time frame: Within two weeks of chest X-ray
Evaluate the performance of chest X-ray based artificial intelligence algorithms to identify individuals with reduced ejection fraction (<40%)
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 14 Sep 2022.
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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.
In Hyun Jung, MD, PhD study chair
Yongin Severance Hospital, Yonsei University College of Medicine
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 for Clinical Evaluation, run by Yonsei University at 1 site in South Korea.
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 2 inclusion and 3 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 14 Sep 2022. 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 South Korea. 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?
Left Ventricular Ejection Fraction < 40% (time frame: Within two weeks of chest X-ray). 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 Sep 2022.