CClinicalTrials.gg
CompletedNCT06478901PRECISE AIUpdated Jun 27, 2024

Precision of AI-Based Cardiac Ultrasound for LVEF in the Elderly

An observational study in Heart Failure, Heart Failure Systolic and Elderly, sponsored by Hôpital Broca APHP. Completed at 1 site in France. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2024-06-27.

Sponsored by Hôpital Broca APHP · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
129
Ages
75 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Heart Failure
  • Heart Failure Systolic
  • Elderly
  • Artificial Intelligence

Keywords

  • Elderly
  • Left ventricular ejection fraction
  • Artificial intelligence
  • Echocardiography
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In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 129 is below the median of 200 across 1,679 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

This is the only study on the registry with Hôpital Broca APHP as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
75 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

75 years or more and a clinical presentation of acute heart failure

Inclusion criteria

  • At least 75 years and a clinical presentation of acute heart failure consistent with the criteria of the European Society of Cardiology guidelines

Exclusion criteria

Exclusion Criteria:

  • unstable patient
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
129 participants (actual)
Target follow-up
129 Days
Patient registry
Yes

Interventions

  • DeviceEchocardiography

    Echocardiography assited by Artificial intelligence

06

What researchers measure

Primary outcomes

  1. evaluate the relevance and accuracy of echocardiography assisted by Artificial intelligence in elderly patients

    The correlation between LVEF measurements from standard echocardiography and AutoEF-AI echocardiography was assessed using the intraclass correlation coefficient (ICC) and Bland-Altman analysis. Weighted Kappa coefficient was calculated to determine agreement between measurements in classifying patients into different categories based on LVEF

    Time frame: From enrollment to the end 48 hours

07

Study locations

1 site
  • Hôpital Broca
    Paris, 75013, France
08

References and documents

Publications

  • Chaudhry SI, Wang Y, Gill TM, Krumholz HM. Geriatric conditions and subsequent mortality in older patients with heart failure. J Am Coll Cardiol. 2010 Jan 26;55(4):309-16. doi: 10.1016/j.jacc.2009.07.066. PubMed 20117435 ↗

Individual participant data

Plan to share: Yes

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06478901
Lead sponsor
Hôpital Broca APHP
Responsible party
Sponsor
First posted
Jun 27, 2024
Start date
Jan 14, 2023
Primary completion
Feb 2, 2024
Completion
Feb 20, 2024
Last update
Jun 27, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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