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

NCT06478901 | Completed DMC

• 1 other identifier: PRECIS-AI-2024-01
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Heart Failure Systolic; Elderly; Artificial Intelligence

Keywords

Elderly; Left ventricular ejection fraction; Artificial intelligence; Echocardiography

Outcome Measures

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

  From enrollment to the end 48 hours

Interventions

Echocardiography DEVICE

Echocardiography assited by Artificial intelligence

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• unstable patient

Sponsors & Collaborators

• Hôpital Broca APHP: lead

Study Sites (1)

Hôpital Broca

Paris, 75013, France

Location

Related Publications (1)

• 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.

  PMID: 20117435 RESULT

MeSH Terms

Conditions

Heart Failure; Heart Failure, Systolic

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 129 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 27, 2024
• Study Start: January 14, 2023
• Primary Completion: February 2, 2024
• Study Completion: February 20, 2024
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)