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

NCT ID: NCT05942729

Last Updated: 2023-07-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2027-01-01

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

Conditions

Hypertension Arterial; Hypokinetic; Cardiomyopathies; Left Ventricular Hypertrophy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients with hypokinetic cardiomyopathy.

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.

Determine the etiology of hypokinetic and hypertrophic heart disease on transthoracic echocardiography data alone

Intervention Type: OTHER

The origin of the pathology will have been previously diagnosed for each patient thanks to complementary examinations performed as part of routine care (e.g. cardiac CT, 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)

Patients with left ventricular hypertrophy related to hypertension/infiltrative myocardial disease

The second arm includes patients with left ventricular hypertrophy, whose aetiology may be various and whose workup is particularly extensive and expensive.

Determine the etiology of hypokinetic and hypertrophic heart disease on transthoracic echocardiography data alone

Intervention Type: OTHER

The origin of the pathology will have been previously diagnosed for each patient thanks to complementary examinations performed as part of routine care (e.g. cardiac CT, 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)

Interventions

Determine the etiology of hypokinetic and hypertrophic heart disease on transthoracic echocardiography data alone

The origin of the pathology will have been previously diagnosed for each patient thanks to complementary examinations performed as part of routine care (e.g. cardiac CT, 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)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Minor patients
• Patients under curatorship or guardianship

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hopital Lyon Sud

Pierre-Bénite, , France

Site Status: RECRUITING

Countries

France

Facility Contacts

Pierre-Yves COURAND, MD, PhD

Role: primary

pierre-yves.courand@chu-lyon.fr

04.78.86.57.37 ext. +33

Other Identifiers

69HCL22_0819

Identifier Type: -

Identifier Source: org_study_id