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Myocardial InfarctionTELECARDNCT03601481

Implementation and Validation of Telemedicine Software for the Automation of MRI Examinations of Acute Myocardial Infarctions

An observational study of Myocardial Infarction, run by Centre Hospitalier Universitaire de Besancon.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Myocardial Infarction
How many people
167 participants
Where
No sites listed yet
Study dates
3 Mar 2014to 3 Jun 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Major patient with heart attack

Who may be able to join

  • Age between 18 years and 75 yeras
  • heart attack with medical treatment within 12 hours
  • heart attack with or without segment S-T gap

Who cannot join

  • cardiogenic choc
  • medical history with heart attack,
  • medical history with left ventricle dysfonction (ejection fraction< 45%),
  • medical history with clinic manifestations of heart failure,
  • medical history with surgical coronary revascularisation in the last 6 months,
  • congenital cardiopathy, myocardiopathy,
Show all 16Show fewer
  • evolutive infection syndrome (HIV, VHB, VHC),
  • chronic inflammatory pathology,
  • leucopenia, thrombopenia, anemia,
  • medical history with treatment by G-CSF; EPO; GM-CSF,
  • stasis trouble, evolutive hemorragic syndrome, transfusion,
  • renal insuffisance (clearance MDRD < 60ml/min),
  • renal insuffisance with creatinin > 120 µmol/L,
  • hepatic insuffisance,
  • medical history of cancer or pathology with life expectancy < 1 year,
  • pregnancy.

About this study

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.

Read the detailed description
  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.
Keywords
telemedicine, cardiac images
Medical subject headings
Myocardial Infarction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Precision of the localisation of endocardic and epicardic edge

    Validation of a software telemedecine for automatic treatment of cardio-vascular MRI

    Measured: Day 2

  2. Volume of myocardic cavity

    Measured: Day 2

  3. Ejection fraction

    Measured: Day 2

  4. Weight of the myocard

    Measured: Day 2

  5. Thickness of the myocard

    Measured: Day 2

  6. Precision of the localisation of endocardic and epicardic edge

    Measured: 6 months

  7. Volume of myocardic cavity

    Measured: 6 months

  8. Weight of the myocard

    Measured: 6 months

  9. Thickness of the myocard

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2018
  2. Study start3 Mar 2014
  3. Primary completion3 Mar 2014
  4. Study completion3 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Retrospective
Enrolment
167 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03601481
Sponsor's protocol ID
API/2012/36
Acronym
TELECARD
Status last verified
Sep 2024
First submitted
17 Jul 2018
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Myocardial Infarction, run by Centre Hospitalier Universitaire de Besancon.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Precision of the localisation of endocardic and epicardic edge (time frame: Day 2). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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