- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06330103
Efficacy of AI EF Screening by Using Smartphone Application Recorded PLAX 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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Rayong, Thailand, 066
- Rayong Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Incomplete VDO clip (too much shaking, too shot recording)
- Lighting was inappropriate
- Inappropriate ultrasound framing
- arrhythmia (atrial fibrillation)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: LV function from cardiologist
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%)
|
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.
Other Names:
|
Experimental: LV function By artificial intelligence
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%)
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
3 month
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RayongH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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