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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06330103
Other study ID # RayongH
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2023
Est. completion date July 31, 2023

Study information

Verified date March 2024
Source Rayong Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 923
Est. completion date July 31, 2023
Est. primary completion date July 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Easy EF
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.

Locations

Country Name City State
Thailand Rayong Hospital Rayong

Sponsors (2)

Lead Sponsor Collaborator
Rayong Hospital Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 3 month
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