Heart FailureNCT06330103
Efficacy of AI EF Screening by Using Smartphone Application Recorded PLAX View Cardiac Ultrasound Video Clips
A study testing Easy EF in people with Heart Failure and Heart Failure With Reduced Ejection Fraction, run by Rayong Hospital at 1 site in Thailand.
Trial summary
Assessing the Efficacy of Artificial Intelligence in Left Ventricular Function Screening Using Parasternal Long Axis View Cardiac Ultrasound Video Clips ABSTRACT BACKGROUND: Echocardiography serves as a fundamental diagnostic procedure for managing heart failure patients. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Heart Failure With Reduced Ejection Fraction, Cardiac Failure
- What is being tested?
- Easy EF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 923 participants
- Where
- 1 siteThailand
- Study dates
- 1 May 2023to 31 Jul 2023
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Shot 5 second VDO clip of Parasternal long axis heart ultrasound recorded by smartphone Application "Easy EF" without patient identification with result of Ejection fraction that performed by certify cardiologist approved result
Who cannot join
- Incomplete VDO clip (too much shaking, too shot recording)
- Lighting was inappropriate
- Inappropriate ultrasound framing
- arrhythmia (atrial fibrillation)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Efficacy of Artificial Intelligence in Left Ventricular Function Screening Using Parasternal Long Axis View Cardiac Ultrasound Video Clips
Assessing the Efficacy of Artificial Intelligence in Left Ventricular Function Screening Using Parasternal Long Axis View Cardiac Ultrasound Video Clips
ABSTRACT BACKGROUND: Echocardiography serves as a fundamental diagnostic procedure for managing heart failure patients. Data from Thailand's Ministry of Public Health reveals that there is a substantial patient population, with over 100,000 admissions annually due to this condition. Nevertheless, the widespread implementation of echocardiography in this patient group remains challenging, primarily due to limitations in specialist resources, particularly in rural community hospitals. Although modern community hospitals are equipped with ultrasound machines capable of basic cardiac assessment (e.g., parasternal long axis view), the demand for expert cardiologists remains a formidable obstacle to achieving comprehensive diagnostic capabilities. Leveraging the capabilities of Artificial Intelligence (AI) technology, proficient in the accurate prediction and processing of diverse healthcare data types, offers a promising for addressing this prevailing issue. This study is designed to assess the effectiveness of AI in evaluating cardiac performance from parasternal long axis view ultrasound video clips obtained via the smartphone application.
OBJECTIVES: To evaluate the effectiveness of artificial intelligence in screening cardiac function from parasternal long axis view cardiac ultrasound video clips obtained through the smartphone application.
Read the detailed description
METHODS: The investigators built the smartphone application to collect parasternal long axis view video clips and used artificial intelligence "Easy EF" to evaluate cardiac function. All samples that were evaluated for LVEF by certified cardiologists, 70% of all clips were used to train AI, while the remaining 30% of clips were used to test if AI could process the results correctly. Artificial intelligence aims to classify cardiac function into three groups: Reduced EF, Mildly Reduced EF, and Preserved LV.
- Conditions
- Heart Failure, Heart Failure With Reduced Ejection Fraction, Cardiac Failure, Echocardiography, Artificial Intelligence
- Being tested
- Easy EF
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Easy EFOther
Also called artificial intelligence, mobile smart phone application
AI was integrated into the application smartphone and used smartphone camera to recorded shot VDO clip of heart ultrasound in parasternal long axis view and returned cardiac function result to user.
| Study group | Role | What they receive |
|---|---|---|
| LV function from cardiologist | Active comparator | Certified Cardiologist will access and interpreted LV function by used traditional Echocardiography then separate result into three group Preserved LV ejection fraction(EF>50%), mildly reduce ejection fraction(EF40-49%), reduced LV ejection fraction(EF<40%) Receives: Other: Easy EF |
| LV function By artificial intelligence | Experimental | AI will access VDO clips in only parasternal long axis view and separate into three group Preserved LV ejection fraction(EF>50%), mildly reduce ejection fraction(EF40-49%), reduced LV ejection fraction(EF<40%) Receives: Other: Easy EF |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficiency of AI in screening left ventricular cardiac function by use smartphone application
percentage of correct LV function clip that interpreted by AI in each LV function group(Preserved LV, Mildly reduced LV, Reduced LV function) and overall compare with result from certified cardiologist
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start1 May 2023
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 923 samples that were evaluated for LVEF by certified cardiologists, 739 clips were used to train AI, while the remaining 184 clips were used to test if AI could process the results correctly. Artificial intelligence aims to classify cardiac function into three groups: Reduced EF, Mildly Reduced EF, and Preserved LV.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 923 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rayong Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chulalongkorn University
- Responsible party
- Principal investigator, Sittiluck Wongwantanee, Rayong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330103
- Sponsor's protocol ID
- RayongH
- Status last verified
- Mar 2024
- First submitted
- 5 Mar 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: result of AI screening
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy of Artificial Intelligence in Left Ventricular Function Screening Using Parasternal Long Axis View Cardiac Ultrasound Video Clips
- ClinicalTrials.gov ID
- NCT06330103
- Acronym / sponsor ID
- RayongH
- Conditions
- Heart Failure, Heart Failure With Reduced Ejection Fraction, Cardiac Failure, Echocardiography, Artificial Intelligence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 923 participants (actual)
- Lead sponsor
- Rayong HospitalUniversity, hospital or other
- Collaborators
- Chulalongkorn University
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 26 Mar 2024 (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.
Assessing the Efficacy of Artificial Intelligence in Left Ventricular Function Screening Using Parasternal Long Axis View Cardiac Ultrasound Video Clips
ABSTRACT BACKGROUND: Echocardiography serves as a fundamental diagnostic procedure for managing heart failure patients. Data from Thailand's Ministry of Public Health reveals that there is a substantial patient population, with over 100,000 admissions annually due to this condition. Nevertheless, the widespread implementation of echocardiography in this patient group remains challenging, primarily due to limitations in specialist resources, particularly in rural community hospitals. Although modern community hospitals are equipped with ultrasound machines capable of basic cardiac assessment (e.g., parasternal long axis view), the demand for expert cardiologists remains a formidable obstacle to achieving comprehensive diagnostic capabilities. Leveraging the capabilities of Artificial Intelligence (AI) technology, proficient in the accurate prediction and processing of diverse healthcare data types, offers a promising for addressing this prevailing issue. This study is designed to assess the effectiveness of AI in evaluating cardiac performance from parasternal long axis view ultrasound video clips obtained via the smartphone application.
OBJECTIVES: To evaluate the effectiveness of artificial intelligence in screening cardiac function from parasternal long axis view cardiac ultrasound video clips obtained through the smartphone application.
Detailed description
METHODS: The investigators built the smartphone application to collect parasternal long axis view video clips and used artificial intelligence "Easy EF" to evaluate cardiac function. All samples that were evaluated for LVEF by certified cardiologists, 70% of all clips were used to train AI, while the remaining 30% of clips were used to test if AI could process the results correctly. Artificial intelligence aims to classify cardiac function into three groups: Reduced EF, Mildly Reduced EF, and Preserved LV.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 923 samples that were evaluated for LVEF by certified cardiologists, 739 clips were used to train AI, while the remaining 184 clips were used to test if AI could process the results correctly. Artificial intelligence aims to classify cardiac function into three groups: Reduced EF, Mildly Reduced EF, and Preserved LV.
| Arm | Type | Receives |
|---|---|---|
| LV function from cardiologist | Active comparator | Other: Easy EFCertified Cardiologist will access and interpreted LV function by used traditional Echocardiography then separate result into three group Preserved LV ejection fraction(EF>50%), mildly reduce ejection fraction(EF40-49%), reduced LV ejection fraction(EF<40%) |
| LV function By artificial intelligence | Experimental | Other: Easy EFAI will access VDO clips in only parasternal long axis view and separate into three group Preserved LV ejection fraction(EF>50%), mildly reduce ejection fraction(EF40-49%), reduced LV ejection fraction(EF<40%) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Shot 5 second VDO clip of Parasternal long axis heart ultrasound recorded by smartphone Application "Easy EF" without patient identification with result of Ejection fraction that performed by certify cardiologist approved result
Key exclusion criteria (4 listed)
- Incomplete VDO clip (too much shaking, too shot recording)
- Lighting was inappropriate
- Inappropriate ultrasound framing
- arrhythmia (atrial fibrillation)
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 |
|---|---|---|
| Easy EFAlso: artificial intelligence, mobile smart phone applicationAI was integrated into the application smartphone and used smartphone camera to recorded shot VDO clip of heart ultrasound in parasternal long axis view and returned cardiac function result to user. | Other | LV function By artificial intelligence, LV function from cardiologist |
Primary outcome
efficiency of AI in screening left ventricular cardiac function by use smartphone application
Time frame: 3 month
percentage of correct LV function clip that interpreted by AI in each LV function group(Preserved LV, Mildly reduced LV, Reduced LV function) and overall compare with result from certified cardiologist
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 Mar 2024.
- Individual participant dataSharing planned: Yes. result of AI screening
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Easy EF in people with Heart Failure and Heart Failure With Reduced Ejection Fraction, run by Rayong Hospital at 1 site in Thailand.
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 4 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 Mar 2024. 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 Thailand. 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?
efficiency of AI in screening left ventricular cardiac function by use smartphone application (time frame: 3 month). 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 Mar 2024; AzTrials last refreshed its copy on 31 Oct 2026.