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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03601481
Recruitment Status : Suspended (Software update needed)
First Posted : July 26, 2018
Last Update Posted : July 30, 2018
Sponsor:
Collaborator:
Centre Hospitalier Universitaire Dijon
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Study Description
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Brief 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.


Condition or disease
Myocardial Infarction

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Study Design
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Study Type : Observational
Estimated Enrollment : 167 participants
Observational Model: Other
Time Perspective: Retrospective
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
Actual Study Start Date : March 3, 2014
Actual Primary Completion Date : March 3, 2014
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. Volume of myocardic cavity [ Time Frame: Day 2 ]
  3. Ejection fraction [ Time Frame: Day 2 ]
  4. Weight of the myocard [ Time Frame: Day 2 ]
  5. Thickness of the myocard [ Time Frame: Day 2 ]
  6. Precision of the localisation of endocardic and epicardic edge [ Time Frame: 6 months ]
  7. Volume of myocardic cavity [ Time Frame: 6 months ]
  8. Weight of the myocard [ Time Frame: 6 months ]
  9. Thickness of the myocard [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Major patient with heart attack
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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,
  • 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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT03601481    
Other Study ID Numbers: API/2012/36
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Besancon:
telemedicine
cardiac images
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases