Viewing Study NCT06478901



Ignite Creation Date: 2024-07-17 @ 11:49 AM
Last Modification Date: 2024-10-26 @ 3:33 PM
Study NCT ID: NCT06478901
Status: COMPLETED
Last Update Posted: 2024-06-27
First Post: 2024-06-10

Brief Title: Precision of AI-Based Cardiac Ultrasound for LVEF in the Elderly
Sponsor: Hôpital Broca APHP
Organization: Hôpital Broca APHP

Study Overview

Official Title: Precision and RElevance of CardIac ultraSound Using Artificial Intelligence for Left Ventricle Ejection Fraction Assessment in the Elderly PRECISE AI
Status: COMPLETED
Status Verified Date: 2024-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: PRECISE AI
Brief Summary: Heart failure HF is common in older adults especially those over 65 It is a leading cause of hospitalization and has high mortality rates Diagnosing HF in elderly patients can be challenging due to atypical symptoms and multiple other health issues Echocardiography an ultrasound of the heart is crucial for accurate diagnosis and treatment planning

One problem in geriatric care is the difficulty of accessing echocardiography due to high demand and limited specialized doctors Recent advancements show that AI-assisted portable ultrasound devices can reliably measure heart function producing results comparable to traditional methods

This study aims to evaluate the accuracy and relevance of AI-assisted echocardiography AutoEF-AI in elderly patients It also assesses whether geriatricians even without specialized training can capture quality images for AI analysis

In simple terms this study investigates if portable ultrasound devices with AI can provide precise heart function diagnostics making it easier for older adults with heart failure to get the care they need even without specialists
Detailed Description: Heart failure HF is a major chronic illness particularly common in older adults With advances in healthcare and an aging population HF is increasingly affecting people over 65 years old In fact 80 of HF patients are over 65 HF is associated with high mortality rates and is the leading cause of hospitalization after age 80 and even after age 65 in some countries like France

In older adults HF symptoms are often atypical due to multiple other health conditions increased frailty and associated geriatric syndromes making diagnosis difficult In this context echocardiography an ultrasound of the heart is essential for accurately diagnosing HF

Evaluating the left ventricular ejection fraction LVEF through echocardiography is a fundamental step in diagnosing HF and deciding on treatment strategies This evaluation helps refine the HF diagnosis propose appropriate treatments and monitor changes in heart function over time

One major challenge in geriatric units and nursing homes EHPADs is the difficulty in accessing echocardiography due to growing demand and a limited number of specialized doctors

Recent studies have shown that automated LVEF measurements assisted by artificial intelligence AI using portable ultrasound devices are reliable and produce results comparable to traditional methods This AI-assisted automatic LVEF calculation AutoEF-AI could be a major advantage in geriatric departments providing a credible alternative to conventional echocardiography for evaluating LVEF in HF patients

The main goal of this study was to evaluate the relevance and accuracy of AutoEF-AI echocardiography in elderly patients The secondary goal was to assess whether geriatricians without specialized training in echocardiography could capture images of sufficient quality to be analyzed by automatic LVEF algorithms with acceptable accuracy

In simple terms this study aims to determine if using portable ultrasound devices assisted by artificial intelligence can provide diagnostics as precise as traditional methods This could make evaluating heart function more accessible and effective for older adults with heart failure even when specialists are not available

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None