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临床试验/NCT03601481
NCT03601481暂停不适用

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

Centre Hospitalier Universitaire de Besancon0 个研究点目标入组 167 人开始时间: 2014年3月3日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
入组人数
167
主要终点
Ejection fraction

研究概览

简要总结

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.

详细描述

  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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Ejection fraction

时间窗: Day 2

Weight of the myocard

时间窗: 6 months

Precision of the localisation of endocardic and epicardic edge

时间窗: 6 months

Volume of myocardic cavity

时间窗: 6 months

Thickness of the myocard

时间窗: 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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