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NCT Number: NCT05942729

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Lyon Sud

Pierre-Bénite, 69310, France

Location status: Recruiting

Location contact

Pierre-Yves COURAND, MD, PhD

CONTACT

[email protected]

04.78.86.57.37 ext. +33

Pierre-Yves COURAND, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Minor patients
  • Patients under curatorship or guardianship

Treatment and study plan

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

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)

Primary outcomes

  1. 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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: ORCHID

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Jul 12, 2023
Registry last updated
Jul 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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