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.
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,
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- 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
- 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.
- 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.
- 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.
- Conditions
- Myocardial Infarction
- 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.
Precision of the localisation of endocardic and epicardic edge
Validation of a software telemedecine for automatic treatment of cardio-vascular MRI
Measured: Day 2
Volume of myocardic cavity
Measured: Day 2
Ejection fraction
Measured: Day 2
Weight of the myocard
Measured: Day 2
Thickness of the myocard
Measured: Day 2
Precision of the localisation of endocardic and epicardic edge
Measured: 6 months
Volume of myocardic cavity
Measured: 6 months
Weight of the myocard
Measured: 6 months
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.
- First posted26 Jul 2018
- Study start3 Mar 2014
- Primary completion3 Mar 2014
- Study completion3 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Dijon
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03601481
- Acronym / sponsor ID
- TELECARD / API/2012/36
- Conditions
- Myocardial Infarction
- Keywords
- telemedicine, cardiac images
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Dijon
- Study start
- 3 Mar 2014 (actual)
- Primary completion
- 3 Mar 2014 (actual)
- Study completion
- 3 Jun 2020 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
- 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.
- 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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Major patient with heart attack
Key inclusion criteria (3 listed)
- Age between 18 years and 75 yeras
- heart attack with medical treatment within 12 hours
- heart attack with or without segment S-T gap
Key exclusion criteria (16 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Precision of the localisation of endocardic and epicardic edge
Time frame: Day 2
Validation of a software telemedecine for automatic treatment of cardio-vascular MRI
Volume of myocardic cavity
Time frame: Day 2
Ejection fraction
Time frame: Day 2
Weight of the myocard
Time frame: Day 2
Thickness of the myocard
Time frame: Day 2
Precision of the localisation of endocardic and epicardic edge
Time frame: 6 months
Volume of myocardic cavity
Time frame: 6 months
Weight of the myocard
Time frame: 6 months
Thickness of the myocard
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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.