Myocardial Infarction Clinical Trial
Official title:
Mise en Place et Validation d'un Logiciel de Télémédecine Permettant l'Automatisation du Traitement Des Examens IRM Des Infarctus du Myocarde en Phase Aigue
Validation of a telemedicine software application for an automated treatment of
cardio-vascular MRI completely identical for both CHUs.
Providing the software application to other CHU seeking a tool suitable for multi-centric
studies.
1. Scientific context:
Cardiac MRI has become a standard technique for determining the size of myocardial
infarction as well as evaluating myocardial function and perfusion. However, the
quantitative analysis of the images targeted on the left and right ventricles relies on
computer treatments often manual so tedious and dependent on the user, or at best
semi-automatic. The absence of a completely automated method limits the extraction of
quantitative and reproducible parameters for each patient, which is necessary for the
follow-up of patients who have had an acute myocardial infarction.
2. Objective (s):
The goal is to integrate in a telemedicine software solution (partnership with the
company Covalia) an automated method of processing these data completely identical for
both CHUs. This development could be made available to other UHC seeking a tool suitable
for multicenter studies.
3. Materials and Methods:
An engineer will be recruited to develop algorithms for robust, reliable and ergonomic
software for the study of myocardial function and perfusion. The software will be accessible
by users via the internet, and will integrate all the security and personal protection
constraints that a telemedicine tool requires. The telemedicine aspect will be done in
partnership with the company Covalia, which obtained for its software solutions CE marking
thanks to an organization ISO 13485 applied to the whole of the company.
The images used for the realization of the software will be taken from the Besançon patient
examinations included in the previous PHRC (1) and will be used after anonymisation.
Validation of the software will be based on current BioCard PHRC examinations in Dijon and
Besançon. This study concerning the implementation and the validation of a software, a
hundred of cases will be included in order to obtain a sufficient representation of the
included population (ie sufficient observable variability) to validate the technical
characteristics of the software (reliability, reproducibility, sensitivity, precision).
The software will automatically provide the calculation of tele-diastolic and tele-systolic
volumes, ejection fraction, thickness and myocardial thickening. In addition, the study of
myocardial infusion after injection of a contrast medium will consist of the construction of
parametric perfusion maps, as well as an automatic determination of myocardial viability. The
development of the computer tool will be based on the software "Quantified Imaging Resource",
developed by Alain Lalande and Alexandre Comte and whose results have already been the
subject of publications.
The aforementioned parameters will be calculated automatically (with the software) and
manually (2 experts will perform these calculations). The results will then be compared and
analyzed by the statisticians of the Besançon and Dijon clinical investigation centers
(1) : Détermination du taux et du type de progéniteurs vasculaires dans l'infarctus
myocardique avec et sans sus décalage du segment ST - 2005 - Dr Meneveau (cardiologie)
4- Expected results and perspectives (less than 30 words)
- Complete software development and validation on the BioCard PHRC exams.
- Integration of the software in a tele-medicine application.
- Submission of at least two articles for international journals.
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