Etiological DiagnOsis of caRdiac Diseases Based on echoCardiograpHIc Images and Clinical Data.

Recruiting

• Conditions: Hypertension Arterial; Cardiomyopathies; Hypokinetic; Left Ventricular Hypertrophy
• Interventions: Other: Determine the etiology of hypokinetic and hypertrophic heart disease on transthoracic echocardiography data alone

• Registration Number: NCT05942729
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Research hypothesis - Recent studies have shown that high-dimensional descriptors of the cardiac function can be efficiently exploited to characterize targeted pathologies. In this project, the investigators hypothesize that echocardiograms possess a wealth of information that is currently under-exploited and that, combined with relevant patient data, will allow the development of robust and accurate digital tools for etiological diagnosis.

Objectives - Based on key advances recently obtained in image analysis, notably by members of the consortium, the objective of this project is to develop rigorous and explainable cardiac disease prediction models from echocardiography based on the transformer paradigm (AI). The strength of this study lies in the development of a strong AI framework to model the complex interactions between high-quality image-based measurements extracted from echocardiograms and relevant patient data to automatically predict etiological diagnosis of cardiac diseases

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Status Verified: 2023-07
• Study First Submitted: 2023-07-04
• Study First Submitted QC: 2023-07-04
• Study First Posted: 2023-07-12
• Last Update Submitted: 2023-07-12
• Last Update Posted: 2023-07-13
• Primary Completion: 2025-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Patients with transthoracic echocardiography with satisfactory image quality (sufficient echogenicity)

Exclusion Criteria

• Minor patients
• Patients under curatorship or guardianship

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with left ventricular hypertrophy related to hypertension/infiltrative myocardial disease	Determine the etiology of hypokinetic and hypertrophic heart disease on transthoracic echocardiography data alone	The second arm includes patients with left ventricular hypertrophy, whose aetiology may be various and whose workup is particularly extensive and expensive.
Patients with hypokinetic cardiomyopathy.	Determine the etiology of hypokinetic and hypertrophic heart disease on transthoracic echocardiography data alone	The first arm includes patients with hypokinetic cardiomyopathy for whom echocardiographic data do not readily distinguish between a cause related to coronary artery disease or related to primary myocardial dysfunction, requiring invasive intervention, i.e., coronary angiography.

Primary Outcome Measures

Name	Time	Method
the comparison of the performance of the etiological diagnosis obtained by the artificial intelligence with the etiological diagnosis already established and validated by a physician from the complementary examinations performed on the targeted patients.	Baseline	The origin of the pathology being previously diagnosed for each patient thanks to complementary examinations carried out in routine (e.g.: cardiac scanner, cardiac MRI, coronary angiography, thorough biology, nuclear medicine). This information will be used (i) to guide the learning of the AI method developed during the project from a sub-population (80% of the collected database will be used to train the algorithms); (ii) to serve as an evaluation criterion from a test sub-population (remaining 20% of the collected database). In addition, visualization tools will be developed to allow clinicians to analyze and interpret the results, particularly with respect to the decision mechanism performed by the algorithm to predict the origin of the pathology. In particular, attention maps will be displayed that will simply allow clinicians to see which data or part of the data was assembled in order to make the decision.

Trial Locations

Locations (1)

Hopital Lyon Sud; 🇫🇷 Pierre-Bénite, France