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临床试验/NCT03234205
NCT03234205已完成不适用

Measurements of Myocardial Relaxation Time by MRI During Respiration

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2011年8月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
9
试验地点
1
主要终点
Movement correction in images assessed by senior radiologists

研究概览

简要总结

Measurement of T2 transversal relaxation time by magnetic resonance has a major interest in cardiac imagery. It has been initially used for quantitative evaluation of heart viability and more recently for edema characterization. It allows to prematurely detect a cardiac transplant rejection. This technique needs successively around ten FSE sequences during apnea. Weak reproducibility of successive apneas and discomfort of patient limit the precision of this measurement and consequently its use in standard care. The ARTEMIS study method allows the examination during free respiration without prolonging the duration of examination compared to the examination during apnea. Moreover, image processing is simplified and correction of respiratory movements renders results more reliable.

This is a pilot study of evaluation of ARTEMIS technique of image reconstruction. ARTEMIS is a method of MRI image reconstruction for measurements of T2 transversal relaxation. It allows to obtain diagnostic images without movement artifacts.

The primary objective si to show the feasibility of ARTEMIS method for measurement of myocardial T2 relaxation time during free respiration in cardiac transplant patients.

The secondary objective is to collect quantitative data to compare ARTEMIS method of measurement of T2 during free respiration and standard clinical practice during apnea.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • To have had a heart transplant, whenever
  • To have an MRI scan of heart with measurement of T2 relaxation time (whatever the reason for examination)
  • To be aware and cooperative
  • Affiliation to social security plan
  • To have given written consent after having received oral and written, clear and intelligible information

排除标准

  • All contraindications to MRI (implantable defibrillator, cochlear implant, neurosurgical clip, intraorbital or encephalic metallic foreign body, endoprosthesis installed since less than 4 weeks, osteosynthesis materials installed since less than 6 weeks...)
  • Instable hemodynamic status, acute respiratory failure, uncertain general status or necessity of continuous monitoring incompatible with MRI examination
  • Minors or being under juridical protection or absence of social security
  • Refusal or impossibility of informed consent of patient

研究组 & 干预措施

MRI scan during free respiration

Experimental

干预措施: MRI scan (Device)

结局指标

主要结局

Movement correction in images assessed by senior radiologists

时间窗: baseline

Image quality assessed y senior radiologists

时间窗: baseline

次要结局

  • Quantitative measurement of myocardial transversal relaxation time in 6 segments of short median axe cross-section of left ventricle in standard and ARTEMIS images(baseline)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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